InfluenzaPhase 2NCT01323946
Study to Evaluate the Immunogenicity and Safety of an Investigational Pandemic Influenza Vaccine in Children
A Phase 2 study testing GSK Biologicals' investigational vaccine GSK1562902A in people with Influenza, run by GlaxoSmithKline at 6 sites in 2 countries.
Trial summary
The objective of the study is to evaluate the immunogenicity and safety of prime-boost vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A. Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GSK Biologicals' investigational vaccine GSK1562902A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 18 Apr 2011to 2 Nov 2012
- 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 6 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that parents/Legally Acceptable Representatives (LARs) can and will comply with the requirements of the protocol.
- Children, male or female between, and including, 6 and 35 months of age at the time of first study vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy children as established by medical history and clinical examination before entering the study.
- Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
- Subjects who are likely to reside in the vicinity of the study centre for the duration of the study. In studies using the home-based model for vaccination and follow-up, subjects who are likely to remain in the vicinity of the area where they were recruited.
Who cannot join
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines such as egg protein or thiomersal.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any neurological disorders or seizures.
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- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned administration during the study period.
- Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
- Child in care.
- Previous vaccination at any time with an H5N1 vaccine.
- Medical history of physician-confirmed infection with a H5N1 virus.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Australia4 sites
GSK Investigational Site
Carlton, Victoria, 3053
GSK Investigational Site
Garran, Australian Capital Territory, 2606
GSK Investigational Site
North Adelaide, South Australia, 5006
GSK Investigational Site
Westmead, New South Wales, 2145
Singapore2 sites
GSK Investigational Site
Singapore, 119074
GSK Investigational Site
Singapore, 228510
About this study
Official title: Safety and Immunogenicity of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine (GSK1562902A) in Children Aged 6 to 35 Months
The objective of the study is to evaluate the immunogenicity and safety of prime-boost vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.
Read the detailed description
This protocol posting was modified according to the protocol amendment 2 (dated 16-June-2011). The impacted section is eligibility criteria.
- Conditions
- Influenza
- Being tested
- GSK Biologicals' investigational vaccine GSK1562902A
- Keywords
- H5N1, influenza infection, 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.
GSK Biologicals' investigational vaccine GSK1562902ABiological
Three intramuscular injections
| Study group | Role | What they receive |
|---|---|---|
| GSK1562902A 6 to 12 M Group | Experimental | Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. Receives: Biological: GSK Biologicals' investigational vaccine GSK1562902A |
| GSK1562902A 12 to 24 M Group | Experimental | Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. Receives: Biological: GSK Biologicals' investigational vaccine GSK1562902A |
| GSK1562902A 24 to 36 M Group | Experimental | Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. Receives: Biological: GSK Biologicals' investigational vaccine GSK1562902A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A seroconverted subject is defined as a subject that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on Day 192.
Measured: At Day 192
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination (Day 192) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer).
Measured: At Day 192
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.
Measured: At Day 192
Secondary outcomes (26)
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain
Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall.
Measured: At Day 0, Day 42, Day 182, Day 192 and Day 364
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain
Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall.
Measured: At Day 0, Day 182, Day 192 and Day 364
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005
A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10.
Measured: At Day 0, Day 42, Day 182, Day 192 and Day 364
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10.
Measured: At Day 0, Day 182, Day 192 and Day 364
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer.
Measured: At Day 42, Day 182, Day 192 and Day 364
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. Data for Day 192 are presented under Primary Outcome Measures.
Measured: At Day 182 and Day 364
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain
A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.
Measured: At Day 0, Day 42, Day 182, Day 192 and Day 364
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40. Data for Day 192 are presented under Primary Outcome Measures.
Measured: Day 0, Day 182 and Day 364
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer).
Measured: At Day 42, Day 182, Day 192 and Day 364
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer). Data for Day 192 are presented under Primary Outcome Measures.
Measured: Day 182 and Day 364
Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Booster seroconversion is defined as follows: For seronegative subjects at pre-booster (Day 182), antibody titer ≥1:40 at post-booster time point(s). For seropositive subjects at pre-booster (Day 182), antibody titer at post-booster time point(s) ≥4-fold the pre-booster antibody titer.
Measured: At Day 192 and Day 364
Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Booster Factor was defined as the geometric mean of the within-subject ratios of the post-booster vaccination reciprocal HI titer to the pre-booster (Day 182) reciprocal titer.
Measured: At Day 192 and Day 364
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28
Measured: Day 0, Day 42, Day 182, Day 192 and Day 364
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28.
Measured: Day 0, Day 182, Day 192 and Day 364
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Titers were presented as geometric mean titers (GMTs).
Measured: Day 0, Day 42, Day 182, Day 192 and Day 364
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Titers were presented as geometric mean titers (GMTs).
Measured: Day 0, Day 182, Day 192 and Day 364
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0)
Measured: At Day 42, Day 182, Day 192 and Day 364
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0)
Measured: At Day 182, Day 192 and Day 364
Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Booster vaccine response is defined as: For seronegative subjects at Day 182, neutralizing antibody titers ≥ 1:56 at the considered time point after vaccination For seropositive subjects at Day 182, neutralizing antibody titers ≥ 4 fold from pre-vaccination (Day 182)
Measured: At Day 192 and Day 364
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assigned were pain, swelling and redness. Any was defined as occurrence of any local symptom regardless of intensity grade; Grade 3 pain was defined as cried when limb was moved spontaneously painful.
Measured: During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed were diarrhoea/ vomiting, drowsiness, irritability/ fussiness, loss of appetite, fever (axillary). Any= occurrence of any general symptom regardless of intensity grade and relationship to the vaccine. Irritability/ fussiness grade 3=crying that could not be comforted/ prevented normal activity; Drowsiness grade 3= drowsiness that prevented normal activity; Loss of appetite grade 3= did not eat at all; Diarrhoea/ vomiting grade 3= diarrhoea/ vomiting that prevented normal activity; Related= general symptom assessed by the investigator as causally related to the study vaccination.
Measured: During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)
Number of Subjects With Medically-attended Events (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.
Measured: During the entire study period (from Day 0 to Day 364)
Number of Subjects With Potential Immune-mediated Disease (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: During the entire study period (from day 0 to Day 364)
Number of Subjects With Unsolicited Adverse Events (AEs)
An AE is 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. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. "Grade 3" was defined as an AE which prevented normal, everyday activities. "Related" was defined as an AE assessed by the investigator as causally related to the study vaccination.
Measured: During a 21 day follow-up period after each vaccination (Day 0 - Day 21, Day 21 - Day 42, Day 182 - Day 203)
Number of Subjects With Unsolicited Adverse Events (AEs)
An AE is 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. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. "Grade 3" was defined as an AE which prevented normal, everyday activities. "Related" was defined as an AE assessed by the investigator as causally related to the study vaccination.
Measured: During an 84 day follow-up period after each vaccination (Day 0 - Day 84, Day 21 - Day 105, Day 182 - Day 266)
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Measured: During the entire study period (from Day 0 to 364)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2011 (estimated)
- Study start18 Apr 2011
- Primary completion22 Jun 2012
- Study completion2 Nov 2012
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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects were to be stratified into three age strata (6 to 11 months, 12 to 23 months and 24 to 35 months) in the ratio of 2:1:1.
- Masking
- None (open label)
- Enrolment
- 113 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
- NCT01323946
- Sponsor's protocol ID
- 109825
- Other IDs
- 2011-004734-33
- Status last verified
- Apr 2019
- First submitted
- 24 Mar 2011
- Last updated
- 7 May 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
Nolan T, Izurieta P, Lee BW, Chan PC, Marshall H, Booy R, Drame M, Vaughn DW. Heterologous prime-boost vaccination using an AS03B-adjuvanted influenza A(H5N1) vaccine in infants and children<3 years of age. J Infect Dis. 2014 Dec 1;210(11):1800-10. doi: 10.1093/infdis/jiu359. Epub 2014 Jun 27.
PubMed 24973461
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine (GSK1562902A) in Children Aged 6 to 35 Months
- ClinicalTrials.gov ID
- NCT01323946
- Acronym / sponsor ID
- 109825
- Conditions
- Influenza
- Keywords
- H5N1, influenza infection, Influenza vaccine GSK1562902A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2011 (actual)
- Primary completion
- 22 Jun 2012 (actual)
- Study completion
- 2 Nov 2012 (actual)
- First posted
- 28 Mar 2011 (estimated)
- Results
- Posted 4 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the immunogenicity and safety of prime-boost vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.
Detailed description
This protocol posting was modified according to the protocol amendment 2 (dated 16-June-2011). The impacted section is eligibility criteria.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Subjects were to be stratified into three age strata (6 to 11 months, 12 to 23 months and 24 to 35 months) in the ratio of 2:1:1.
| Arm | Type | Receives |
|---|---|---|
| GSK1562902A 6 to 12 M Group | Experimental | Biological: GSK Biologicals' investigational vaccine GSK1562902ASubjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. |
| GSK1562902A 12 to 24 M Group | Experimental | Biological: GSK Biologicals' investigational vaccine GSK1562902ASubjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. |
| GSK1562902A 24 to 36 M Group | Experimental | Biological: GSK Biologicals' investigational vaccine GSK1562902ASubjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subjects who the investigator believes that parents/Legally Acceptable Representatives (LARs) can and will comply with the requirements of the protocol.
- Children, male or female between, and including, 6 and 35 months of age at the time of first study vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy children as established by medical history and clinical examination before entering the study.
- Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
Key exclusion criteria (13 listed)
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines such as egg protein or thiomersal.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
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 |
|---|---|---|
| GSK Biologicals' investigational vaccine GSK1562902AThree intramuscular injections | Biological | GSK1562902A 12 to 24 M Group, GSK1562902A 24 to 36 M Group, GSK1562902A 6 to 12 M Group |
Primary outcome
Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Time frame: At Day 192
A seroconverted subject is defined as a subject that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on Day 192.
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
Time frame: At Day 192
Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination (Day 192) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer).
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
Time frame: At Day 192
A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.
26 secondary outcomes
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain
Time frame: At Day 0, Day 42, Day 182, Day 192 and Day 364
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain
Time frame: At Day 0, Day 182, Day 192 and Day 364
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005
Time frame: At Day 0, Day 42, Day 182, Day 192 and Day 364
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Time frame: At Day 0, Day 182, Day 192 and Day 364
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Time frame: At Day 42, Day 182, Day 192 and Day 364
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Time frame: At Day 182 and Day 364
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain
Time frame: At Day 0, Day 42, Day 182, Day 192 and Day 364
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Time frame: Day 0, Day 182 and Day 364
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Time frame: At Day 42, Day 182, Day 192 and Day 364
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
Time frame: Day 182 and Day 364
Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Time frame: At Day 192 and Day 364
Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Time frame: At Day 192 and Day 364
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Time frame: Day 0, Day 42, Day 182, Day 192 and Day 364
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Time frame: Day 0, Day 182, Day 192 and Day 364
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Time frame: Day 0, Day 42, Day 182, Day 192 and Day 364
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Time frame: Day 0, Day 182, Day 192 and Day 364
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Time frame: At Day 42, Day 182, Day 192 and Day 364
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Time frame: At Day 182, Day 192 and Day 364
Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Time frame: At Day 192 and Day 364
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)
Number of Subjects With Medically-attended Events (MAEs)
Time frame: During the entire study period (from Day 0 to Day 364)
Number of Subjects With Potential Immune-mediated Disease (pIMDs)
Time frame: During the entire study period (from day 0 to Day 364)
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During a 21 day follow-up period after each vaccination (Day 0 - Day 21, Day 21 - Day 42, Day 182 - Day 203)
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During an 84 day follow-up period after each vaccination (Day 0 - Day 84, Day 21 - Day 105, Day 182 - Day 266)
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Day 0 to 364)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24973461Nolan T, Izurieta P, Lee BW, Chan PC, Marshall H, Booy R, Drame M, Vaughn DW. Heterologous prime-boost vaccination using an AS03B-adjuvanted influenza A(H5N1) vaccine in infants and children<3 years of age. J Infect Dis. 2014 Dec 1;210(11):1800-10. doi: 10.1093/infdis/jiu359. Epub 2014 Jun 27.
- 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
6 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 GSK Biologicals' investigational vaccine GSK1562902A in people with Influenza, run by GlaxoSmithKline at 6 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 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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, Singapore. 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 4 Feb 2019). 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?
Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain (time frame: At Day 192). The study lists 3 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 NCT01323946, 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 7 May 2019.