InfluenzaPhase 2NCT00502593

Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Children

A Phase 2 study testing Pandemic Influenza Vaccine (GSK1562902A) and Fluarix™ in people with Influenza, run by GlaxoSmithKline at 7 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The present study is designed to evaluate in children (aged between 3 and 9 years) the immunogenicity and safety of different antigen doses of the candidate vaccine (GSK1562902A) administered following a two-administration schedule (21 days apart). Subjects in the control group will receive Fluarix. Read more about this study

Who is it for?: Ages 3 to 9 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Pandemic Influenza Vaccine (GSK1562902A) and Fluarix™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 138 participants
Where: 7 sitesSpain
Study dates: 23 Jul 2007to 4 Dec 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 9 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Children who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
Children aged between and including 3 and 9 years of age at the time of first vaccination.
Written informed consent obtained from the parent(s) or guardian of the subject.
Healthy children as established by medical history and clinical examination before entering the study.
Subjects who are likely to reside in the vicinity of the study center for the duration of the study.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) other than the investigational vaccine within 30 days prior to the enrolment in this study, or planned use during the study period.
Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination, with the exception of routine childhood inoculations which cannot be delayed, but which must not be administered on the same day as the investigational vaccine candidate.
Administration of the interpandemic influenza vaccine 21 days prior to Day 0 or up to Day 51.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the enrolment in this study.
Any chronic drug therapy to be continued during the study period, with the exception of inhalative treatment for seasonal allergies or asthma.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

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Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
History of hypersensitivity to vaccines.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines used in this study.
History of any neurological disorders or seizures.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study or planned during the study.
Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Spain7 sites

GSK Investigational Site
Blanes (Girona), 17300
GSK Investigational Site
L'Eliana, Valencia, 46183
GSK Investigational Site
Paiporta, Valencia, 46200
GSK Investigational Site
Quart de Poblet, Valencia, 46930
GSK Investigational Site
Valencia, 46008
GSK Investigational Site
Valencia, 46011
GSK Investigational Site
Valencia, 46024

Other trials in Spain

About this study

Official title: A Phase II, Randomized, Open, Controlled Study to Evaluate the Safety and Immunogenicity of Different Formulations of a Pandemic Influenza Vaccine Candidate (Split Virus Formulation Adjuvanted With AS03) Given Following a Two-administration Schedule (21 Days Apart) in Children Between 3 and 9 Years of Age.

Read the detailed description

This 107066 study is a participating study to the broader NCT00502593 study, which included 2 other studies, the 108498 and 108500 studies. The NCT00502593 study had a staggered design (subjects from each group being enrolled sequentially into 2 age strata, '6-9 years' 1st, and '3-5 years' next) and was run in 3 phases, phases A (Study 107066), B (Study 108498) and C (Study 108500). In each phase, the decision to vaccinate subjects aged 3-5 years and to administer a 2nd injection to subjects aged 6-9 years was made based on safety data collected on Days 0-6 after the 1st injection for the subjects aged 6-9 years. Decision to start Phase B was made on complete safety data including those collected on Day 28 of Phase A (7 days after the 2nd injection) for each age group. A similar approach was to be used to start Phase C. As safety data in Phase A did not raise any safety concerns, Phases B and C were run in parallel.

Conditions: Influenza
Being tested: Pandemic Influenza Vaccine (GSK1562902A), Fluarix™
Keywords: Influenza, Pandemic Influenza Vaccine (GSK1562902A)
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pandemic Influenza Vaccine (GSK1562902A)Biological
2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.
Fluarix™Biological
2 doses, intramuscular injection on Days 0 and 21.

Study groups in NCT00502593
Study group	Role	What they receive
GSK1562902A-A Lot 1 3-5Y Group	Experimental	Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. Receives: Biological: Pandemic Influenza Vaccine (GSK1562902A)
Fluarix-A 3-5Y Group	Active comparator	Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. Receives: Biological: Fluarix™
GSK1562902A-A Lot 1 6-9Y Group	Experimental	Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. Receives: Biological: Pandemic Influenza Vaccine (GSK1562902A)
Fluarix-A 6-9Y Group	Active comparator	Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. Receives: Biological: Fluarix™
GSK1562902A-B Lot 2 3-5Y Group	Experimental	Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. Receives: Biological: Pandemic Influenza Vaccine (GSK1562902A)
Fluarix-B 3-5Y Group	Active comparator	Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. Receives: Biological: Fluarix™
GSK1562902A-B Lot 2 6-9Y Group	Experimental	Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. Receives: Biological: Pandemic Influenza Vaccine (GSK1562902A)
Fluarix-B 6-9Y Group	Active comparator	Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. Receives: Biological: Fluarix™
GSK1562902A-C Lot 3 3-5Y Group	Experimental	Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. Receives: Biological: Pandemic Influenza Vaccine (GSK1562902A)
Fluarix-C 3-5Y Group	Active comparator	Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. Receives: Biological: Fluarix™
GSK1562902A-C Lot 3 6-9Y Group	Experimental	Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. Receives: Biological: Pandemic Influenza Vaccine (GSK1562902A)
Fluarix-C 6-9Y Group	Active comparator	Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21. Receives: Biological: Fluarix™

What is being measured

The primary outcome is the main question the study is designed to answer.

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.
Measured: At Day 0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10
Measured: At Day 21
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10
Measured: At Day 42
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.
Measured: At Month 6
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10
Measured: At Month 12
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10
Measured: At Month 24
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer below (<) 1:10 and a post-vaccination HI antibody titer above than or equal to (≥)1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Measured: At Day 21
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Measured: At Day 42
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Measured: At Month 6
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Measured: At Month 12
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Measured: At Month 24
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Measured: At Day 21
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Measured: At Day 42
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Measured: At Month 6
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Measured: At Month 12
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Measured: At Month 24
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Measured: At Day 0
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Measured: At Day 21
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Measured: At Day 42
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)
Measured: At Month 6
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)
Measured: At Month 12
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Measured: At Month 24
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase A of the study.
Measured: During the 7 day follow-up period after each vaccination
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase C of the study.
Measured: During the 7-day follow-up period after each vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever (axillary temperature above or equal (≥) 37.5°C), irritability, loss of appetite, shivering, sweating and vomiting. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature > 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results for subjects aged between 3 and 5 years participating in Phases A, B and C of the study.
Measured: During the 7-day (Days 0-6) follow-up period after any vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and fever, assessed as oral temperature above or equal (≥) 37.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Grade 3 fever= oral temperature ≥ 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results related to subjects aged 6 to 9 years participating in the study phases A, B and C.
Measured: During the 7-day (Days 0-6) follow-up period after any vaccination
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating to Phase B of the study.
Measured: During the 7-day follow-up period after each vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.
Measured: During the entire study (Day 0 to Month 24)
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event. Grade 3 AE = AE that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Related = symptom assessed as causally related to study vaccination.
Measured: During a 21 day follow-up period after the first vaccination, during a 30-day follow-up period after the second vaccination
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A
Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase A of the study.
Measured: At Days 21 and 42 and Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase A of the study.
Measured: At Days 21 and 42 and Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase A of the study.
Measured: At Days 21 and 42 and Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase A of the study.
Measured: At Days 21 and 42 and Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase A of the study.
Measured: At Days 21 and 42 and Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase A of the study
Measured: At Days 21 and 42 and Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase B of the study.
Measured: At Days 21 and 42 and Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase B of the study.
Measured: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase B of the study.
Measured: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase B of the study.
Measured: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase B of the study.
Measured: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase B of the study.
Measured: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase C of the study.
Measured: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase C of the study.
Measured: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C
Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase C of the study.
Measured: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase C of the study.
Measured: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase C of the study.
Measured: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase C of the study.
Measured: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results for subjects participating in Phase A of the study.
Measured: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results for subjects participating in Phase A of the study.
Measured: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results for subjects participating in Phase A of the study.
Measured: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase A of the study.
Measured: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results for subjects participating in Phase A of the study.
Measured: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results for subjects participating in Phase A of the study.
Measured: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.
Measured: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.
Measured: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase B of the study.
Measured: At Days 0, 21 and 42 and at Month 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase B of the study.
Measured: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase B of the study.
Measured: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase C of the study.
Measured: At Days 0, 21 and 42 and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results, for subjects participating to Phase C of the study.
Measured: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase B of the study.
Measured: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase C of the study.
Measured: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase C of the study.
Measured: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating to Phase C of the study.
Measured: At Days 0, 21 and 42 and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase C of the study.
Measured: At Days 0, 21 and 42 and at Months 6, 12 and 24

Secondary outcomes (9)

Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease
Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET).Results presented are for subjects participating in Phase A of the study
Measured: At Days 0, 21 and 42
Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease
Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET). Results presented are for subjects participating in Phase B of the study.
Measured: At Days 0, 21 and 42
Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease
Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET). Results presented are for subjects participating in Phase C of the study.
Measured: At Days 0, 21 and 42
Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies
A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase A of the study.
Measured: At Days 21 and 42
Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies
A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase B of the study.
Measured: At Days 21 and 42
Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies
A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase C of the study.
Measured: At Days 21 and 42
Titers for Serum Neutralizing Antibodies Against 2 Strains of Influenza Disease
Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO) strains. Results presented are for subjects participating in Phase A of the study. Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.
Measured: At Months 6, 12 and 24
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease as Regards to Neutralizing Antibody Response
A seroconverted subject as regards to neutralizing antibody response was a subject with a minimum 4-fold increase in neutralizing antibody titer at post-vaccination. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO) strains. Results presented are for subjects participating in Phase A of the study. Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.
Measured: At Months 6, 12 and 24.
Number of Subjects With Adverse Events of Specific Interest (AESIs)
AESIs are adverse events such as clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. AESIs assessed included neuroinflammatory disorders such as cranial nerve disorders, multiple sclerosis,transverse myelitis, Guillain-Barré syndromeor neuritis), musculoskeletal disorders (such as systemic lupus erythematosus, cutaneous lupus, polymyositis, rheumatoid arthritis, reactive arthritis, psoriatic arthropathy, or undifferentiated spondyloarthropathy), gastrointestinal disorders (such as Crohn's disease, ulcerative colitis, ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, Addison's disease). skin disorders (such as psoriasis, vitiligo, Raynaud's phenomenon, or autoimmune bullous skin diseases), and other conditions as autoimmune hemolytic anemia, thrombocytopenias, antiphospholipid syndrome, vasculitis, autoimmune hepatitis, or sarcoidosis.
Measured: Throughout the entire study period, from Day 0 to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jul 20074 Dec 2009

First posted17 Jul 2007 (estimated)
Study start23 Jul 2007
Primary completion4 Dec 2009
Study completion4 Dec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00502593
Sponsor's protocol ID: 107066
Other IDs: 108498, 108500
Status last verified: Jun 2017
First submitted: 16 Jul 2007
Last updated: 25 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Diez-Domingo J, Baldo JM, Planelles-Catarino MV, Garces-Sanchez M, Ubeda I, Jubert-Rosich A, Mares J, Garcia-Corbeira P, Moris P, Teko M, Vanden Abeele C, Gillard P. Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination. Influenza Other Respir Viruses. 2015 Mar;9(2):68-77. doi: 10.1111/irv.12295. Epub 2015 Feb 5.
PubMed 25652873
Diez-Domingo J, Garces-Sanchez M, Baldo JM, Planelles MV, Ubeda I, JuBert A, Mares J, Moris P, Garcia-Corbeira P, Drame M, Gillard P. Immunogenicity and Safety of H5N1 A/Vietnam/1194/2004 (Clade 1) AS03-adjuvanted prepandemic candidate influenza vaccines in children aged 3 to 9 years: a phase ii, randomized, open, controlled study. Pediatr Infect Dis J. 2010 Jun;29(6):e35-46. doi: 10.1097/INF.0b013e3181daf921.
PubMed 20375709

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Questions to ask the study team

What is the study trying to find out?
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Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Open, Controlled Study to Evaluate the Safety and Immunogenicity of Different Formulations of a Pandemic Influenza Vaccine Candidate (Split Virus Formulation Adjuvanted With AS03) Given Following a Two-administration Schedule (21 Days Apart) in Children Between 3 and 9 Years of Age.
ClinicalTrials.gov ID: NCT00502593
Acronym / sponsor ID: 107066
Conditions: Influenza
Keywords: Influenza, Pandemic Influenza Vaccine (GSK1562902A)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 23 Jul 2007
Primary completion: 4 Dec 2009 (actual)
Study completion: 4 Dec 2009 (actual)
First posted: 17 Jul 2007 (estimated)
Results: Posted 3 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 12

Arm	Type	Receives
GSK1562902A-A Lot 1 3-5Y Group	Experimental	Biological: Pandemic Influenza Vaccine (GSK1562902A)Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Fluarix-A 3-5Y Group	Active comparator	Biological: Fluarix™Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
GSK1562902A-A Lot 1 6-9Y Group	Experimental	Biological: Pandemic Influenza Vaccine (GSK1562902A)Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Fluarix-A 6-9Y Group	Active comparator	Biological: Fluarix™Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
GSK1562902A-B Lot 2 3-5Y Group	Experimental	Biological: Pandemic Influenza Vaccine (GSK1562902A)Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Fluarix-B 3-5Y Group	Active comparator	Biological: Fluarix™Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
GSK1562902A-B Lot 2 6-9Y Group	Experimental	Biological: Pandemic Influenza Vaccine (GSK1562902A)Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Fluarix-B 6-9Y Group	Active comparator	Biological: Fluarix™Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
GSK1562902A-C Lot 3 3-5Y Group	Experimental	Biological: Pandemic Influenza Vaccine (GSK1562902A)Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Fluarix-C 3-5Y Group	Active comparator	Biological: Fluarix™Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
GSK1562902A-C Lot 3 6-9Y Group	Experimental	Biological: Pandemic Influenza Vaccine (GSK1562902A)Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Fluarix-C 6-9Y Group	Active comparator	Biological: Fluarix™Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Who may qualify

Ages: 3 to 9 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Children who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
Children aged between and including 3 and 9 years of age at the time of first vaccination.
Written informed consent obtained from the parent(s) or guardian of the subject.
Healthy children as established by medical history and clinical examination before entering the study.
Subjects who are likely to reside in the vicinity of the study center for the duration of the study.

Key exclusion criteria (13 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the investigational vaccine within 30 days prior to the enrolment in this study, or planned use during the study period.
Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination, with the exception of routine childhood inoculations which cannot be delayed, but which must not be administered on the same day as the investigational vaccine candidate.
Administration of the interpandemic influenza vaccine 21 days prior to Day 0 or up to Day 51.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the enrolment in this study.
Any chronic drug therapy to be continued during the study period, with the exception of inhalative treatment for seasonal allergies or asthma.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pandemic Influenza Vaccine (GSK1562902A)2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.	Biological	GSK1562902A-A Lot 1 3-5Y Group, GSK1562902A-A Lot 1 6-9Y Group, GSK1562902A-B Lot 2 3-5Y Group, GSK1562902A-B Lot 2 6-9Y Group, GSK1562902A-C Lot 3 3-5Y Group, GSK1562902A-C Lot 3 6-9Y Group
Fluarix™2 doses, intramuscular injection on Days 0 and 21.	Biological	Fluarix-A 3-5Y Group, Fluarix-A 6-9Y Group, Fluarix-B 3-5Y Group, Fluarix-B 6-9Y Group, Fluarix-C 3-5Y Group, Fluarix-C 6-9Y Group

Primary outcome

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: At Day 0
Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: At Day 21
Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: At Day 42
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: At Month 6
Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: At Month 12
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: At Month 24
Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease
Time frame: At Day 21
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer below (<) 1:10 and a post-vaccination HI antibody titer above than or equal to (≥)1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease
Time frame: At Day 42
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease
Time frame: At Month 6
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease
Time frame: At Month 12
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease
Time frame: At Month 24
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: At Day 21
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: At Day 42
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: At Month 6
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: At Month 12
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: At Month 24
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
Time frame: At Day 0
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
Time frame: At Day 21
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
Time frame: At Day 42
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
Time frame: At Month 6
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
Time frame: At Month 12
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
Time frame: At Month 24
A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Time frame: During the 7 day follow-up period after each vaccination
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase A of the study.
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Time frame: During the 7-day follow-up period after each vaccination
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase C of the study.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) follow-up period after any vaccination
Assessed solicited general symptoms were drowsiness, fever (axillary temperature above or equal (≥) 37.5°C), irritability, loss of appetite, shivering, sweating and vomiting. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature > 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results for subjects aged between 3 and 5 years participating in Phases A, B and C of the study.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) follow-up period after any vaccination
Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and fever, assessed as oral temperature above or equal (≥) 37.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Grade 3 fever= oral temperature ≥ 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results related to subjects aged 6 to 9 years participating in the study phases A, B and C.
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Time frame: During the 7-day follow-up period after each vaccination
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating to Phase B of the study.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study (Day 0 to Month 24)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events
Time frame: During a 21 day follow-up period after the first vaccination, during a 30-day follow-up period after the second vaccination
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event. Grade 3 AE = AE that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Related = symptom assessed as causally related to study vaccination.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A
Time frame: At Days 21 and 42 and Months 6, 12 and 24
Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase A of the study.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A
Time frame: At Days 21 and 42 and Months 6, 12 and 24
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase A of the study.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A
Time frame: At Days 21 and 42 and Months 6, 12 and 24
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase A of the study.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A
Time frame: At Days 21 and 42 and Months 6, 12 and 24
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase A of the study.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A
Time frame: At Days 21 and 42 and Months 6, 12 and 24
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase A of the study.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A
Time frame: At Days 21 and 42 and Months 6, 12 and 24
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase A of the study
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B
Time frame: At Days 21 and 42 and Months 6, 12 and 24
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase B of the study.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase B of the study.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase B of the study.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase B of the study.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase B of the study.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase B of the study.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase C of the study.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase C of the study.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase C of the study.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase C of the study.
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase C of the study.
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase C of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results for subjects participating in Phase A of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results for subjects participating in Phase A of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results for subjects participating in Phase A of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase A of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results for subjects participating in Phase A of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results for subjects participating in Phase A of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B
Time frame: At Days 0, 21 and 42 and at Month 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase B of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase B of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase B of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C
Time frame: At Days 0, 21 and 42 and at Months 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase C of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results, for subjects participating to Phase C of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase B of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase C of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase C of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C
Time frame: At Days 0, 21 and 42 and at Months 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating to Phase C of the study.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C
Time frame: At Days 0, 21 and 42 and at Months 6, 12 and 24
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase C of the study.

9 secondary outcomes

Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease
Time frame: At Days 0, 21 and 42
Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease
Time frame: At Days 0, 21 and 42
Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease
Time frame: At Days 0, 21 and 42
Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies
Time frame: At Days 21 and 42
Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies
Time frame: At Days 21 and 42
Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies
Time frame: At Days 21 and 42
Titers for Serum Neutralizing Antibodies Against 2 Strains of Influenza Disease
Time frame: At Months 6, 12 and 24
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease as Regards to Neutralizing Antibody Response
Time frame: At Months 6, 12 and 24.
Number of Subjects With Adverse Events of Specific Interest (AESIs)
Time frame: Throughout the entire study period, from Day 0 to Month 24

Results and safety

Results posted to the registry on 3 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK1562902A-A Lot 1 3-5Y Group	51	48
Fluarix-A 3-5Y Group	18	16
GSK1562902A-A Lot 1 6-9Y Group	51	41
Fluarix-A 6-9Y Group	18	14
GSK1562902A-B Lot 2 3-5Y Group	51	47
Fluarix-B 3-5Y Group	17	17
GSK1562902A-B Lot 2 6-9Y Group	49	44
Fluarix-B 6-9Y Group	17	17
GSK1562902A-C Lot 3 3-5Y Group	49	43
Fluarix-C 3-5Y Group	17	17
GSK1562902A-C Lot 3 6-9Y Group	49	47
Fluarix-C 6-9Y Group	18	18

Primary outcome: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Time frame: At Day 0. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	GSK1562902A-A Lot 1 3-5Y Group n = 49	Fluarix-A 3-5Y Group n = 15	GSK1562902A-A Lot 1 6-9Y Group n = 43	Fluarix-A 6-9Y Group n = 15	GSK1562902A-B Lot 2 3-5Y Group n = 42	Fluarix-B 3-5Y Group n = 16	GSK1562902A-B Lot 2 6-9Y Group n = 45	Fluarix-B 6-9Y Group n = 17	GSK1562902A-C Lot 3 3-5Y Group n = 44	Fluarix-C 3-5Y Group n = 15	GSK1562902A-C Lot 3 6-9Y Group n = 43	Fluarix-C 6-9Y Group n = 13
A/VIET	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	5.1 (4.9 to 5.4)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)
A/INDO	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Population analysed: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Primary outcome: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Time frame: At Day 21. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	GSK1562902A-A Lot 1 3-5Y Group n = 49	Fluarix-A 3-5Y Group n = 15	GSK1562902A-A Lot 1 6-9Y Group n = 43	Fluarix-A 6-9Y Group n = 15	GSK1562902A-B Lot 2 3-5Y Group n = 41	Fluarix-B 3-5Y Group n = 16	GSK1562902A-B Lot 2 6-9Y Group n = 45	Fluarix-B 6-9Y Group n = 17	GSK1562902A-C Lot 3 3-5Y Group n = 43	Fluarix-C 3-5Y Group n = 15	GSK1562902A-C Lot 3 6-9Y Group n = 30	Fluarix-C 6-9Y Group n = 9
A/VIET	8.7 (6.2 to 12.3)	NA (NA to NA)	12.1 (8.4 to 17.5)	NA (NA to NA)	22.7 (14.6 to 35.3)	NA (NA to NA)	23.7 (14.3 to 39.1)	NA (NA to NA)	25.0 (16.0 to 39.3)	5.7 (4.3 to 7.7)	27.3 (16.2 to 46.0)	NA (NA to NA)
A/INDO	5.2 (4.9 to 5.6)	NA (NA to NA)	5.2 (4.8 to 5.8)	NA (NA to NA)	5.5 (4.9 to 6.2)	NA (NA to NA)	5.3 (4.9 to 5.8)	NA (NA to NA)	7.7 (6.0 to 9.8)	NA (NA to NA)	6.0 (5.0 to 7.2)	NA (NA to NA)

Primary outcome: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Time frame: At Day 42. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	GSK1562902A-A Lot 1 3-5Y Group n = 49	Fluarix-A 3-5Y Group n = 15	GSK1562902A-A Lot 1 6-9Y Group n = 43	Fluarix-A 6-9Y Group n = 15	GSK1562902A-B Lot 2 3-5Y Group n = 42	Fluarix-B 3-5Y Group n = 16	GSK1562902A-B Lot 2 6-9Y Group n = 45	Fluarix-B 6-9Y Group n = 17	GSK1562902A-C Lot 3 3-5Y Group n = 44	Fluarix-C 3-5Y Group n = 15	GSK1562902A-C Lot 3 6-9Y Group n = 43	Fluarix-C 6-9Y Group n = 13
A/VIET	392.7 (280.4 to 550.2)	NA (NA to NA)	540.3 (424.5 to 687.7)	NA (NA to NA)	678.1 (475.7 to 966.6)	NA (NA to NA)	615.8 (429 to 884)	NA (NA to NA)	956.4 (769.2 to 1189.3)	NA (NA to NA)	883.5 (737.3 to 1058.6)	NA (NA to NA)
A/INDO	53.5 (35 to 81.7)	NA (NA to NA)	60.8 (38.7 to 95.5)	NA (NA to NA)	73.7 (45.2 to 120.3)	NA (NA to NA)	64.9 (38.7 to 108.9)	NA (NA to NA)	167.9 (121.7 to 231.5)	NA (NA to NA)	92.5 (59.3 to 144.2)	NA (NA to NA)

Primary outcome: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Time frame: At Month 6. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	GSK1562902A-A Lot 1 3-5Y Group n = 50	Fluarix-A 3-5Y Group n = 15	GSK1562902A-A Lot 1 6-9Y Group n = 44	Fluarix-A 6-9Y Group n = 14	GSK1562902A-B Lot 2 3-5Y Group n = 47	Fluarix-B 3-5Y Group n = 16	GSK1562902A-B Lot 2 6-9Y Group n = 45	Fluarix-B 6-9Y Group n = 17	GSK1562902A-C Lot 3 3-5Y Group n = 29	Fluarix-C 3-5Y Group n = 11	GSK1562902A-C Lot 3 6-9Y Group n = 41	Fluarix-C 6-9Y Group n = 16
A/VIET	29.3 (19.2 to 44.6)	5.9 (4.2 to 8.3)	33.4 (21.2 to 52.7)	NA (NA to NA)	46.3 (29.8 to 72.0)	NA (NA to NA)	43.2 (27.9 to 66.8)	NA (NA to NA)	80.0 (47.0 to 136.4)	NA (NA to NA)	61.5 (38.9 to 97.3)	NA (NA to NA)
A/INDO	6.9 (5.6 to 8.4)	NA (NA to NA)	6.6 (5.2 to 8.4)	NA (NA to NA)	21.7 (14.3 to 33.0)	NA (NA to NA)	11.9 (8.4 to 16.9)	NA (NA to NA)	42.5 (23.7 to 76.3)	NA (NA to NA)	36.8 (22.3 to 60.6)	NA (NA to NA)

Population analysed: The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK1562902A -A Lot 1 3-5Y Group	0 of 51 (0%)	42 of 51 (82.4%)	Not reported
Fluarix-A 3-5Y Group	0 of 18 (0%)	17 of 18 (94.4%)	Not reported
GSK1562902A-A Lot 1 6-9Y Group	0 of 51 (0%)	48 of 51 (94.1%)	Not reported
Fluarix-A 6-9Y Group	0 of 18 (0%)	14 of 18 (77.8%)	Not reported
GSK1562902A-B Lot 2 3-5Y Group	1 of 51 (2%)	42 of 51 (82.4%)	Not reported
Fluarix-B 3-5Y Group	1 of 17 (5.9%)	11 of 17 (64.7%)	Not reported
GSK1562902A-B Lot 2 6-9Y Group	0 of 49 (0%)	41 of 49 (83.7%)	Not reported
Fluarix-B 6-9Y Group	0 of 17 (0%)	13 of 17 (76.5%)	Not reported
GSK1562902A-C Lot 3 3-5Y Group	2 of 49 (4.1%)	43 of 49 (87.8%)	Not reported
Fluarix-C 3-5Y Group	0 of 17 (0%)	13 of 17 (76.5%)	Not reported
GSK1562902A-C Lot 3 6-9Y Group	1 of 49 (2%)	46 of 49 (93.9%)	Not reported
Fluarix-C 6-9Y Group	0 of 18 (0%)	17 of 18 (94.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25652873Diez-Domingo J, Baldo JM, Planelles-Catarino MV, Garces-Sanchez M, Ubeda I, Jubert-Rosich A, Mares J, Garcia-Corbeira P, Moris P, Teko M, Vanden Abeele C, Gillard P. Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination. Influenza Other Respir Viruses. 2015 Mar;9(2):68-77. doi: 10.1111/irv.12295. Epub 2015 Feb 5.
Derived from this study: PubMed 20375709Diez-Domingo J, Garces-Sanchez M, Baldo JM, Planelles MV, Ubeda I, JuBert A, Mares J, Moris P, Garcia-Corbeira P, Drame M, Gillard P. Immunogenicity and Safety of H5N1 A/Vietnam/1194/2004 (Clade 1) AS03-adjuvanted prepandemic candidate influenza vaccines in children aged 3 to 9 years: a phase ii, randomized, open, controlled study. Pediatr Infect Dis J. 2010 Jun;29(6):e35-46. doi: 10.1097/INF.0b013e3181daf921.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pandemic Influenza Vaccine (GSK1562902A) and Fluarix™ in people with Influenza, run by GlaxoSmithKline at 7 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease (time frame: At Day 0). The study lists 65 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00502593, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.