InfluenzaPhase 2NCT00397215

Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Adults Over 60 Years of Age

A Phase 2 study testing Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) and Fluarix in people with Influenza, run by GlaxoSmithKline at 12 sites in 2 countries.

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 the immunogenicity and safety of a single or double dose of the pandemic influenza candidate vaccine (GSK1562902A), administered following a two-administration schedule (21 days apart) in adults over 60 years of age. Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) and Fluarix
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 437 participants
Where: 12 sitesin 2 countries
Study dates: 17 Nov 2006to 14 Sep 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 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female aged 61 years or above at the time of the first vaccination.
Written informed consent obtained from the subject.
Healthy subjects or subjects with well controlled underlying disease.

Who cannot join

Administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ during the 2006-2007 influenza season.
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 H5N1 vaccine.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of chronic alcohol consumption and/or drug abuse.

Show all 14Show fewer

History of hypersensitivity to vaccines.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (including egg and thiomersal allergy).
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Acute disease at the time of enrolment.
Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
Administration of immunoglobulins and/or any blood products within the three months preceding the first vaccination or during the study.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Trial locations and contacts

12 sites in 2 countries.

Country

City, postcode or hospital

12 sites in 2 countries

Belgium7 sites

GSK Investigational Site
Dour, 7370
GSK Investigational Site
Gozée, 6534
GSK Investigational Site
Libramont, 6800
GSK Investigational Site
Mont-Godinne, 5530
GSK Investigational Site
Sprimont, 4140
GSK Investigational Site
Tessenderlo, 3980
GSK Investigational Site
Watermael-Boitsfort, 1170

Other trials in Belgium

Italy5 sites

GSK Investigational Site
Genoa, Liguria, 16132
GSK Investigational Site
Milan, Lombardy, 20127
GSK Investigational Site
Monserrato Cagliari, Sardinia, 09042
GSK Investigational Site
Ragusa, Sicily, 97100
GSK Investigational Site
Sassari, Sardinia, 07100

Other trials in Italy

About this study

Official title: Evaluate Immunogenicity & Safety of a Single or Double-dose of the Pandemic Influenza Candidate Vaccine (GSK1562902A) Given Following a Two-administration Schedule (21 Days Apart) in Adults Over 60 Yrs

Read the detailed description

The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the candidate vaccine in healthy elderly persons. The candidate vaccine will be administered following a two-administration schedule (21 days apart) in adults over 60 years of age. The persistence of H5N1 influenza antibodies will also be evaluated up to two years after vaccination (neutralizing antibodies will only be evaluated in a subset of subjects in the adjuvanted groups). Single and double dose of H5N1 vaccine non-adjuvanted vaccine will be used as comparator.

Conditions: Influenza
Being tested: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not), Fluarix
Keywords: H5N1, influenza, vaccine
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) (adjuvanted or not)Biological
intramuscular injection
FluarixBiological
Intramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.

Study groups in NCT00397215
Study group	Role	What they receive
GSK1562902A 1 Group	Experimental	Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Receives: Biological: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not); Biological: Fluarix
GSK1562902A 2 Group	Experimental	Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Receives: Biological: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not); Biological: Fluarix
GSK1562902A 3 Group	Experimental	Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in the deltoid region of each arm. Receives: Biological: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not); Biological: Fluarix
GSK1562902A 4 Group	Experimental	Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in the deltoid region of each arm. Receives: Biological: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not); 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 Two Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Measured: At Days 0, 21 and 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 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: At Days 21 and 42
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: At Days 0, 21 and 42
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.
Measured: At Days 0 and 42
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: At Days 21 and 42
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.
Measured: At Day 42
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Measured: At Day 180
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Measured: At Month 12
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Measured: At Month 24
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: At Day 180
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: At Month 12
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
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 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: At Day 180
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 (H5N1) and A/Indonesia/5/2005 (H5N1).
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 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: At Month 24
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: At Day 180
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: At Month 12
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: At Month 24
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.
Measured: At Day 180
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.
Measured: At Month 12
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.
Measured: At Month 24
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.
Measured: At Month 12
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.
Measured: At Month 24
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.
Measured: At Day 180

Secondary outcomes (12)

Number of Subjects With Adverse Events of Specific Interest (AESIs)
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Note: No AESIs were reported during the entire study period.
Measured: During the entire study period (Day 0 to Month 24)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Measured: During the 7-day follow-up period (Days 0 to 6) after any vaccination
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.
Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), creatinine phosphokinase (CRPH), creatinine (CREA), eosinophils (EOS), haemoglobin (HEM), lactate dehydrogenase (LDE), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), urea (URE) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT, AST, BAS, CREA and CRPH.
Measured: At Days 0, 2, 21 and 23
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 or result in disability/incapacity. Note: The study period was divided into 4 consecutive periods (Days 0-51, Days 52-180 [Month 6], Months 6-12 and Months 12-24), for which SAEs were collected.
Measured: During the entire study period (Day 0 to Month 24).
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Measured: During the 21-day (Days 0-20) follow-up period after first vaccination and during the 30-day (Days 0-29) follow-up period after second vaccination
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.
Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), creatinine phosphokinase (CRPH), creatinine (CREA), eosinophils (EOS), haemoglobin (HEM), lactate dehydrogenase (LDE), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), urea (URE) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents EOS, HEM, LDE, LYM and MON results.
Measured: At Days 0, 2, 21 and 23.
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], tumor necrosis factor-alpha [TNF-α] or interferon-gamma [IFN-γ].
Measured: At Month 12
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], tumor necrosis factor-alpha [TNF-α] or interferon-gamma [IFN-γ].
Measured: At Month 24
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (HEM), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents NEU, PLA, RBC, URE and WBC results.
Measured: At Days 0, 2, 21 and 23.
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], interferon gamma [INF-g] and tumor necrosis factor-alpha [TNF-α].
Measured: At Days 0, 21 and 42
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells
The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], tumor necrosis factor-alpha [TNF-α] or interferon-gamma [IFN-γ].
Measured: At Day 180
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-day follow-up period (Days 0 to 6) after any vaccination

Timeline

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

17 Nov 200614 Sep 2009

First posted8 Nov 2006 (estimated)
Study start17 Nov 2006
Primary completion14 Sep 2009
Study completion14 Sep 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: 437 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00397215
Sponsor's protocol ID: 108251
Other IDs: 108252, 111275, 111276, 2006-004041-42
Status last verified: Feb 2019
First submitted: 7 Nov 2006
Last updated: 10 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
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

Gillard P, Giet D, Heijmans S, Drame M, Walravens K, Roman F. Long-term outcome of the humoral and cellular immune response of an H5N1 adjuvanted influenza vaccine in elderly persons: 2-year follow-up of a randomised open-label study. Trials. 2014 Oct 29;15:419. doi: 10.1186/1745-6215-15-419.
PubMed 25354581
Heijmans S, De Meulemeester M, Reynders P, Giet D, Demanet E, Devresse PY, Icardi G, Drame M, Roman F, Gillard P. Immunogenicity profile of a 3.75-mug hemagglutinin pandemic rH5N1 split virion AS03A-adjuvanted vaccine in elderly persons: a randomized trial. J Infect Dis. 2011 Apr 15;203(8):1054-62. doi: 10.1093/infdis/jiq174.
PubMed 21450995

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluate Immunogenicity & Safety of a Single or Double-dose of the Pandemic Influenza Candidate Vaccine (GSK1562902A) Given Following a Two-administration Schedule (21 Days Apart) in Adults Over 60 Yrs
ClinicalTrials.gov ID: NCT00397215
Acronym / sponsor ID: 108251
Conditions: Influenza
Keywords: H5N1, influenza, vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 437 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 17 Nov 2006 (actual)
Primary completion: 14 Sep 2009 (actual)
Study completion: 14 Sep 2009 (actual)
First posted: 8 Nov 2006 (estimated)
Results: Posted 20 May 2013

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: 4

Arm	Type	Receives
GSK1562902A 1 Group	Experimental	Biological: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not), Biological: FluarixSubjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
GSK1562902A 2 Group	Experimental	Biological: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not), Biological: FluarixSubjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
GSK1562902A 3 Group	Experimental	Biological: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not), Biological: FluarixSubjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in the deltoid region of each arm.
GSK1562902A 4 Group	Experimental	Biological: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not), Biological: FluarixSubjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in the deltoid region of each arm.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female aged 61 years or above at the time of the first vaccination.
Written informed consent obtained from the subject.
Healthy subjects or subjects with well controlled underlying disease.

Key exclusion criteria (14 listed)

Administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ during the 2006-2007 influenza season.
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 H5N1 vaccine.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

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) (adjuvanted or not)intramuscular injection	Biological	GSK1562902A 1 Group, GSK1562902A 2 Group, GSK1562902A 3 Group, GSK1562902A 4 Group
FluarixIntramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.	Biological	GSK1562902A 1 Group, GSK1562902A 2 Group, GSK1562902A 3 Group, GSK1562902A 4 Group

Primary outcome

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Time frame: At Days 0, 21 and 42
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.
Time frame: At Days 21 and 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 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
Time frame: At Days 0, 21 and 42
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Time frame: At Days 0 and 42
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
Time frame: At Days 21 and 42
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
Time frame: At Day 42
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Time frame: At Day 180
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two 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 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Time frame: At Month 24
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
Time frame: At Day 180
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
Time frame: At Month 12
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
Time frame: At Month 24
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.
Time frame: At Day 180
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 (H5N1) and A/Indonesia/5/2005 (H5N1).
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 (H5N1) and A/Indonesia/5/2005 (H5N1).
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 (H5N1) and A/Indonesia/5/2005 (H5N1).
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
Time frame: At Day 180
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
Time frame: At Month 12
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
Time frame: At Month 24
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
Time frame: At Day 180
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
Time frame: At Month 12
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
Time frame: At Month 24
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two 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 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Time frame: At Month 24
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Time frame: At Day 180
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.

12 secondary outcomes

Number of Subjects With Adverse Events of Specific Interest (AESIs)
Time frame: During the entire study period (Day 0 to Month 24)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Time frame: During the 7-day follow-up period (Days 0 to 6) after any vaccination
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.
Time frame: At Days 0, 2, 21 and 23
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (Day 0 to Month 24).
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Time frame: During the 21-day (Days 0-20) follow-up period after first vaccination and during the 30-day (Days 0-29) follow-up period after second vaccination
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.
Time frame: At Days 0, 2, 21 and 23.
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
Time frame: At Month 12
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
Time frame: At Month 24
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.
Time frame: At Days 0, 2, 21 and 23.
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
Time frame: At Days 0, 21 and 42
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells
Time frame: At Day 180
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Time frame: During the 7-day follow-up period (Days 0 to 6) after any vaccination

Results and safety

Results posted to the registry on 20 May 2013, 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 1 Group	165	158
GSK1562902A 2 Group	61	56
GSK1562902A 3 Group	159	153
GSK1562902A 4 Group	52	48

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

Time frame: At Days 0, 21 and 42. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	GSK1562902A 1 Group n = 152	GSK1562902A 2 Group n = 54	GSK1562902A 3 Group n = 145	GSK1562902A 4 Group n = 44
A/Vietnam/1194/2004, Day 0	11.3 (9.2 to 13.9)	9.7 (7.3 to 13.0)	10.2 (8.4 to 12.5)	8.8 (6.6 to 11.8)
A/Vietnam/1194/2004, Day 21	50.0 (38.1 to 65.6)	16.8 (11.7 to 24.0)	69.4 (52.1 to 92.3)	20.8 (13.0 to 33.3)
A/Vietnam/1194/2004, Day 42	126.8 (99.4 to 161.7)	22.7 (15.1 to 34.1)	237.3 (191.9 to 293.6)	25.3 (16.0 to 40.1)
A/Indonezia/5/2005, Day 0	5.1 (5.0 to 5.1)	5.2 (4.9 to 5.5)	5.1 (5.0 to 5.2)	5.0 (5.0 to 5.0)
A/Indonezia/5/2005, Day 21	6.9 (6.2 to 7.7)	5.3 (4.8 to 5.9)	8.6 (7.3 to 10.1)	5.6 (5.0 to 6.3)
A/Indonezia/5/2005, Day 42	13.7 (11.3 to 16.4)	6.1 (5.1 to 7.4)	24.4 (19.9 to 30.0)	6.3 (5.2 to 7.6)

Population analysed: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.

Primary outcome: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.

Time frame: At Days 21 and 42. Geometric mean (95% Confidence Interval). Unit: Fold

Measure	GSK1562902A 1 Group n = 152	GSK1562902A 2 Group n = 54	GSK1562902A 3 Group n = 145	GSK1562902A 4 Group n = 44
A/Vietnam/1994/2004, Day 21	4.4 (3.5 to 5.5)	1.7 (1.3 to 2.3)	6.8 (5.3 to 8.6)	2.4 (1.7 to 3.4)
A/Vietnam/1994/2004, Day 42	11.2 (8.9 to 14.1)	2.3 (1.6 to 3.3)	23.2 (18.5 to 29.0)	2.9 (2.0 to 4.1)
A/Indonezia/5/2005, Day 21	1.4 (1.2 to 1.5)	1.0 (0.9 to 1.1)	1.7 (1.4 to 2.0)	1.1 (1.0 to 1.3)
A/Indonezia/5/2005, Day 42	2.7 (2.2 to 3.2)	1.2 (1.0 to 1.4)	4.8 (3.9 to 5.9)	1.3 (1.0 to 1.5)

Primary outcome: Number of Seroprotected Subjects Against 2 Strains of Influenza Disease

Time frame: At Days 0, 21 and 42. Number. Unit: Subjects

Measure	GSK1562902A 1 Group n = 152	GSK1562902A 2 Group n = 54	GSK1562902A 3 Group n = 145	GSK1562902A 4 Group n = 44
A/Vietnam/1194/2004, Day 0	28	7	23	2
A/Vietnam/1194/2004, Day 21	93	15	90	15
A/Vietnam/1194/2004, Day 42	127	19	139	17
A/Indonezia/5/2005, Day 0	0	0	0	0
A/Indonezia/5/2005, Day 21	5	1	13	1
A/Indonezia/5/2005, Day 42	35	2	59	2

Primary outcome: Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.

Time frame: At Days 0 and 42. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	GSK1562902A 1 Group n = 87	GSK1562902A 3 Group n = 82
A/Vietnam/1194/2004, Day 0	121.1 (94.6 to 154.9)	112.5 (90.7 to 139.5)
A/Vietnam/1194/2004, Day 42	447.3 (359.3 to 557.0)	595.8 (487.7 to 727.8)
A/Indonesia/5/2005, Day 0	44.2 (36.0 to 54.1)	39.7 (32.0 to 49.3)
A/Indonesia/5/2005, Day 42	107.5 (88.9 to 130.0)	169.6 (144.7 to 198.9)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK1562902A 1 Group	19 of 165 (11.5%)	69 of 164 (42.1%)	0 of 165
GSK1562902A 2 Group	11 of 61 (18%)	8 of 61 (13.1%)	2 of 61
GSK1562902A 3 Group	16 of 159 (10.1%)	75 of 159 (47.2%)	3 of 159
GSK1562902A 4 Group	5 of 52 (9.6%)	6 of 51 (11.8%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25354581Gillard P, Giet D, Heijmans S, Drame M, Walravens K, Roman F. Long-term outcome of the humoral and cellular immune response of an H5N1 adjuvanted influenza vaccine in elderly persons: 2-year follow-up of a randomised open-label study. Trials. 2014 Oct 29;15:419. doi: 10.1186/1745-6215-15-419.
Background: PubMed 21450995Heijmans S, De Meulemeester M, Reynders P, Giet D, Demanet E, Devresse PY, Icardi G, Drame M, Roman F, Gillard P. Immunogenicity profile of a 3.75-mug hemagglutinin pandemic rH5N1 split virion AS03A-adjuvanted vaccine in elderly persons: a randomized trial. J Infect Dis. 2011 Apr 15;203(8):1054-62. doi: 10.1093/infdis/jiq174.
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

12 sites in 2 countries: 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) (adjuvanted or not) and Fluarix in people with Influenza, run by GlaxoSmithKline at 12 sites in 2 countries.

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 4 inclusion and 14 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 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Belgium, Italy. 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 20 May 2013). 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 Two Strains of Influenza Disease. (time frame: At Days 0, 21 and 42). The study lists 24 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 NCT00397215, 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 10 Jun 2019.