InfluenzaPhase 4NCT01196026
Immunogenicity and Safety Study of Fluarix™ Vaccine in Children Who Have Previously Been Vaccinated With Pandemrix™
A Phase 4 study testing Fluarix™ and Havrix™ Junior in people with Influenza, run by GlaxoSmithKline at 7 sites in 2 countries.
Trial summary
This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' Fluarix vaccine in children who have previously been vaccinated with two doses of Pandemrix at the age of 6 months-9 years. Read more about this study
- Who is it for?
- Ages 1 year to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluarix™ and Havrix™ Junior
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 15 Sep 2010to 26 May 2011
- Phase
- Phase 4
- 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 1 year to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects having previously been immunized with two 0.25 mL doses of Pandemrix, given at least 21 days apart, at the age of 6 months to 9 years inclusive at the time of first vaccination.
- Subjects having received the last dose of Pandemrix at least six months prior to study enrolment.
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/LAR(s) of the subjects.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
Who cannot join
- Active participation in other clinical trials.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
- Acute disease and/or fever at the time of enrolment.
- 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.
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study.
- Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- History of seizures or progressive neurological disease.
- Subjects having received an H1N1v pandemic vaccine other than Pandemrix or having received the 2010/2011 seasonal influenza vaccine.
- Child in care.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Sweden6 sites
GSK Investigational Site
Karlskrona, SE-371 41
GSK Investigational Site
Malmö, SE-205 02
GSK Investigational Site
Örebro, SE-702 11
GSK Investigational Site
Skellefteå, SE-931 86
GSK Investigational Site
Stockholm, SE-118 83
GSK Investigational Site
Umeå, SE-901 85
About this study
Official title: Immunogenicity and Safety Study of GSK Biologicals' Seasonal (2010-2011) Influenza Vaccine Fluarix™ in Children Previously Vaccinated With GSK Biologicals' H1N1 Vaccine Pandemrix™
This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' Fluarix vaccine in children who have previously been vaccinated with two doses of Pandemrix at the age of 6 months-9 years.
- Conditions
- Influenza
- Being tested
- Fluarix™, Havrix™ Junior
- Keywords
- Influenza, H1N1, Fluarix, Pandemrix
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluarix™Biological
One or two intramuscular injections
Havrix™ JuniorBiological
Two intramuscular injections
| Study group | Role | What they receive |
|---|---|---|
| Fluarix 6-11 months Group | Experimental | Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine Receives: Biological: Fluarix™ |
| Fluarix 12-35 months Group | Experimental | Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine Receives: Biological: Fluarix™ |
| Fluarix 3-9 years Group | Experimental | Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine Receives: Biological: Fluarix™ |
| Havrix Junior 6-11 months Group | Active comparator | Subjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine Receives: Biological: Havrix™ Junior |
| Havrix Junior 12-35 months Group | Active comparator | Subjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine Receives: Biological: Havrix™ Junior |
| Havrix Junior 3-9 years Group | Active comparator | Subjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine Receives: Biological: Havrix™ Junior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
Antibody titers were expressed as Geometric mean titers (GMTs).
Measured: Day 0 and 28
Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
Seropositivity was defined as antibody titers greater than or equal to 1:10.
Measured: Day 0-28
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Measured: Day 0-28
Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
A seroconverted subject was defined as a subject that had either a prevaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Measured: Day 28
Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.
Measured: Day 28
Secondary outcomes (26)
HI Antibody Titers Against All Fluarix Vaccine Strains
Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were Flu A/CAL/7/09 H1N1 , FluB/Bri/60/08 Victoria, and Flu A/Vic/210/09 H3N2, further in this summary denoted as H1N1, Victoria and H3N2 strains, respectively.
Measured: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Measured: Day 0 and Month 6
Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains
Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Measured: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Measured: Day 0 and Month 6
Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Measured: Day 28
Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Measured: Month 6
Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Measured: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Measured: Day 0 and Month 6
Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Measured: Day 28
Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Month 6) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.
Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Measured: Month 6
Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains
Antibody titers were expressed as Geometric Mean Titers (GMTs).
Measured: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Antibody titers were expressed as GMTs.] Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Measured: Day 0 and Month 6
Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains
Seropositivity was defined as antibody titers greater than or equal to 1:28.
Measured: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Seropositivity was defined as antibody titers greater than or equal to 1:28. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Measured: Day 0 and Month 6
Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix
Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.
Measured: Day 28
Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.
Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Measured: Month 6
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed include: pain, redness and swelling. Any is any symptom regardless of intensity. Grade 3 was defined as a symptom that prevented normal activity.above 50 millimeter.
Measured: During the 7 days (Day 0 - 6) after vaccination
Duration of Any Solicited Local Symptom
Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include: pain, redness and swelling.
Measured: During the 7 days (Days 0 - 6) after vaccination
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 loss of appetite was not eating at all; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.
Measured: During the 7 days (Days 0-6) after vaccination
Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old
Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever.
Measured: During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.
Measured: During a 7-day follow-up period (Day 0-6) after vaccination
Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever.
Measured: During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE 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 any symptom regardless of intensity or relationship to vaccination. Grade 3 was a symptom preventing normal everyday activity. Related was any symptom assessed by the investigator as causally related to the study vaccination.
Measured: During a 28 day follow-up period (Day 0-27) after vaccination
Number of Subjects Reporting Medically-Attended Events (MAEs), Adverse Events of Specific Interest (AESIs)/ Potential Immune Mediated Diseases (pIMDs) and Adverse Events (AEs) of Special Interest
MAEs: subject received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
AESIs/pIMD: includes both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Adverse events of special interest include both convulsion and anaphylaxis.
Measured: During the entire study period (up to Month 6)
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs: 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.
Measured: Up to Day 28
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs: 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.
Measured: Up to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study start15 Sep 2010
- Primary completion26 May 2011
- Study completion26 May 2011
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 (1)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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196026
- Sponsor's protocol ID
- 114451
- Status last verified
- Sep 2016
- First submitted
- 3 Sep 2010
- Last updated
- 24 Sep 2018
- 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
Vesikari T, Richardus JH, Berglund J, Korhonen T, Flodmark CE, Lindstrand A, Silfverdal SA, Bambure V, Caplanusi A, Dieussaert I, Roy-Ghanta S, Vaughn DW. Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated with an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine: Two Open-label, Randomized Trials. Pediatr Infect Dis J. 2015 Jul;34(7):774-82. doi: 10.1097/INF.0000000000000709.
PubMed 26069949
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of GSK Biologicals' Seasonal (2010-2011) Influenza Vaccine Fluarix™ in Children Previously Vaccinated With GSK Biologicals' H1N1 Vaccine Pandemrix™
- ClinicalTrials.gov ID
- NCT01196026
- Acronym / sponsor ID
- 114451
- Conditions
- Influenza
- Keywords
- Influenza, H1N1, Fluarix, Pandemrix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2010
- Primary completion
- 26 May 2011 (actual)
- Study completion
- 26 May 2011 (actual)
- First posted
- 8 Sep 2010 (estimated)
- Results
- Posted 28 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' Fluarix vaccine in children who have previously been vaccinated with two doses of Pandemrix at the age of 6 months-9 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Fluarix 6-11 months Group | Experimental | Biological: Fluarix™Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine |
| Fluarix 12-35 months Group | Experimental | Biological: Fluarix™Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine |
| Fluarix 3-9 years Group | Experimental | Biological: Fluarix™Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine |
| Havrix Junior 6-11 months Group | Active comparator | Biological: Havrix™ JuniorSubjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine |
| Havrix Junior 12-35 months Group | Active comparator | Biological: Havrix™ JuniorSubjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine |
| Havrix Junior 3-9 years Group | Active comparator | Biological: Havrix™ JuniorSubjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subjects having previously been immunized with two 0.25 mL doses of Pandemrix, given at least 21 days apart, at the age of 6 months to 9 years inclusive at the time of first vaccination.
- Subjects having received the last dose of Pandemrix at least six months prior to study enrolment.
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/LAR(s) of the subjects.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Key exclusion criteria (12 listed)
- Active participation in other clinical trials.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
- Acute disease and/or fever at the time of enrolment.
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 |
|---|---|---|
| Fluarix™One or two intramuscular injections | Biological | Fluarix 12-35 months Group, Fluarix 3-9 years Group, Fluarix 6-11 months Group |
| Havrix™ JuniorTwo intramuscular injections | Biological | Havrix Junior 12-35 months Group, Havrix Junior 3-9 years Group, Havrix Junior 6-11 months Group |
Primary outcome
Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
Time frame: Day 0 and 28
Antibody titers were expressed as Geometric mean titers (GMTs).
Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
Time frame: Day 0-28
Seropositivity was defined as antibody titers greater than or equal to 1:10.
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
Time frame: Day 0-28
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
Time frame: Day 28
A seroconverted subject was defined as a subject that had either a prevaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
Time frame: Day 28
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.
26 secondary outcomes
HI Antibody Titers Against All Fluarix Vaccine Strains
Time frame: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Time frame: Day 0 and Month 6
Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains
Time frame: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Time frame: Day 0 and Month 6
Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
Time frame: Day 28
Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Time frame: Month 6
Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains
Time frame: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Time frame: Day 0 and Month 6
Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
Time frame: Day 28
Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Time frame: Month 6
Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains
Time frame: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Time frame: Day 0 and Month 6
Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains
Time frame: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Time frame: Day 0 and Month 6
Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix
Time frame: Day 28
Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Time frame: Month 6
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7 days (Day 0 - 6) after vaccination
Duration of Any Solicited Local Symptom
Time frame: During the 7 days (Days 0 - 6) after vaccination
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7 days (Days 0-6) after vaccination
Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: During a 28 day follow-up period (Day 0-27) after vaccination
Number of Subjects Reporting Medically-Attended Events (MAEs), Adverse Events of Specific Interest (AESIs)/ Potential Immune Mediated Diseases (pIMDs) and Adverse Events (AEs) of Special Interest
Time frame: During the entire study period (up to Month 6)
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: Up to Day 28
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: Up to Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26069949Vesikari T, Richardus JH, Berglund J, Korhonen T, Flodmark CE, Lindstrand A, Silfverdal SA, Bambure V, Caplanusi A, Dieussaert I, Roy-Ghanta S, Vaughn DW. Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated with an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine: Two Open-label, Randomized Trials. Pediatr Infect Dis J. 2015 Jul;34(7):774-82. doi: 10.1097/INF.0000000000000709.
- 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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Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluarix™ and Havrix™ Junior in people with Influenza, run by GlaxoSmithKline at 7 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 6 inclusion and 12 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 24 Sep 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 Sweden, Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 28 Jun 2012). 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?
Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine (time frame: Day 0 and 28). The study lists 5 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 NCT01196026, which also lists 1 linked publication.
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 24 Sep 2018.