Evaluate reactogenicity & immunogenicity of an influenza pandemic candidate vaccine (GSK1562902A) in primed adults
Trial overview
Titers for serum H5N1 haemagglutinin inhibition (HI) antibodies against the A/Indonesia/05/2005 strain
Timeframe: At Day 0
Titers for serum H5N1 haemagglutinin inhibition (HI) antibodies against the A/Indonesia/05/2005 strain
Timeframe: At Day 21
Number of seroconverted subjects for H5N1 HI antibodies against the A/Indonesia/05/2005 strain
Timeframe: At Day 21
Seroconversion factor (SCF) for H5N1 HI antibodies against the A/Indonesia/05/2005 strain
Timeframe: At Day 21
Number of seroprotected subjects for H5N1 HI antibodies against the A/Indonesia/05/2005 strain
Timeframe: At Day 0
Number of seroprotected subjects for H5N1 HI antibodies against the A/Indonesia/05/2005 strain
Timeframe: At Day 21
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)
Timeframe: During the 21-day (Days 0-20) follow-up period after the first vaccination and 30-day (Days 0-29) follow-up period after the second vaccination
Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)
Timeframe: During the 30-day (Days 0-29) follow-up period after the first vaccination
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (From Day 0 up to Month 24)
Titers for serum neutralizing HI antibodies against A/Indonesia/05/2005 strain
Timeframe: At Days 0, 21 (post-vaccination one) and 42 (post-vaccination two)
Titers for serum neutralizing HI antibodies against A/Indonesia/05/2005 stain
Timeframe: At Months 6, 12, 18 and 24
Titers for serum H5N1 haemaglutinin-inhibition (HI) antibodies against the A/Indonesia/05/2005 strain
Timeframe: At Days 0, 7, 14, 21, 28, 35 and 42
Titers for serum H5N1 HI antibodies against the A/Indonesia/05/2005 strain
Timeframe: At Months 6, 12, 18 and 24
Number of seroconverted (SCR) subjects for HI antibodies against the A/Indonesia/05/2005 strain
Timeframe: At Days 7,14, 21, 35 and 42
Number of seroconverted (SCR) subjects for HI antibodies against the A/Indonesia/05/2005 strain
Timeframe: At Months 6, 12, 18 and 24
Number of seroconverted (SCR) subjects for neutralizing HI antibodies against the A/Indonesia/05/2005 strain
Timeframe: At Days 21 (post-vaccination one) and 42 (post-vaccination two)
Number of seroconverted (SCR) subjects for neutralizing HI antibodies against the A/Indonesia/05/2005 strain
Timeframe: At Months 6, 12, 18 and 24
Seroconversion factor (SCF) for H5N1 haemagglutinin-inhibition (HI) antibodies against the A/Indonesia/05/2005 strain
Timeframe: At Days 7, 14, 21, 35 and 42
Seroconversion factor (SCF) for H5N1 haemagglutinin-inhibition (HI) antibodies against the A/Indonesia/05/2005 strain
Timeframe: At Months 6, 12, 18 and 24
Number of seroprotected (SPR) subjects for HI antibodies against the A/Indonesia/05/2005 strain
Timeframe: At Days 0, 7, 14, 21, 28, 35 and 42
Number of seroprotected (SPR) subjects for HI antibodies against the A/Indonesia/05/2005 strain
Timeframe: At Months 6, 12, 18 and 24
Frequency of antigen-specific CD4/CD8 T-cells (per 10E6) in tests identified as producing at least two out of four different cytokines
Timeframe: At Days 0 and 21
Frequency of antigen-specific CD4/CD8 T-cells (per 10E6) in tests identified as producing at least two out of four different cytokines
Timeframe: At Months 6, 12, 18 and 24
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- For previously primed subjects: participation in the primary study (NCT00309634).
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- For unprimed subjects who did not participate in the primary study (NCT00309634): Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
•Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study. •For previously primed subjects: participation in the primary study (NCT00309634). •For unprimed subjects: male or female between and including, 19 and 61 years of age at the time of the first vaccination. •Written informed consent obtained from the subject. •Healthy subjects as established by medical history and clinical examination before entering into the study. •If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. •For unprimed subjects who did not participate in the primary study (NCT00309634): Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. •Planned administration/ administration of a licenced vaccine not foreseen by the study protocol within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) of the first dose of vaccine(s). •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). •Applicable for control group only: previous vaccination with a pandemic candidate vaccine or a vaccine containing the investigational vaccine adjuvant. •History of hypersensitivity to vaccines. •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). •Major congenital defects or serious chronic illness. •History of any neurological disorders or seizures. •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 screening tests. •Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. •Any condition which, in the opinion of the investigator, prevents the subject from participation in the study. •Lactating female. •History of chronic alcohol consumption and/or drug abuse
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.