Evaluate safety & immunogenicity of GSK Bio's influenza vaccine GSK576389A after repeated vaccination in elderly adults
Trial overview
Number of subjects reporting any and grade 3 solicited local adverse events (AEs)
Timeframe: During a 7-day follow-up period after vaccination
Duration of solicited local adverse events
Timeframe: During a 7-day follow-up period after vaccination
Number of subjects reporting any, grade 3 and related solicited general adverse events (AEs)
Timeframe: During a 7-day follow-up period after vaccination
Duration of solicited general adverse events
Timeframe: During a 7-day follow-up period after vaccination
Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs)
Timeframe: During a 21-day follow-up period after vaccination
Number of subjects with any and related serious adverse events (SAEs)
Timeframe: During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)
Number of subjects reporting any and related medically significant conditions (MSCs)
Timeframe: During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)
Serum hemagglutination-inhibition (HI) antibody titers against each of the three vaccine strains
Timeframe: At Days 0 and 21
Number of subjects seroconverted for HI antibodies against each of the three vaccine strains
Timeframe: At Day 21
Seroconversion factors for HI antibodies against each of the three vaccine strains
Timeframe: At Day 21
Number of subjects seroprotected for HI antibodies against each of the three vaccine strains
Timeframe: At Days 0 and 21
Number of Cluster of Differentiation 4 (CD4) T-cells (per million CD4 T-cells) producing at least 2 different immune markers
Timeframe: At Day 0 and 21
Number of CD4 T-cells (per million CD4 T-cells) producing at least CD40L and another immune marker
Timeframe: At Day 0 and 21
Number of CD4 T-cells (per million CD4 T-cells) producing at least IFN-γ and another immune marker
Timeframe: At Day 0 and 21
Number of CD4 T-cells (per million CD4 T-cells) producing at least IL-2 and another immune marker
Timeframe: At Day 0 and 21
Number of CD4 T-cells (per million CD4 T-cells) producing at least TNF-α and another immune marker
Timeframe: At Day 0 and 21
Number of Cluster of Differentiation 8 (CD8) T-cells (per million CD8 T-cells) expressing at least 2 different immune markers
Timeframe: At Day 0 and 21
Number of CD8 T-cells (per million CD8 T-cells) producing at least CD40L and another immune marker
Timeframe: At Day 0 and 21
Number of CD8 T-cells (per million CD8 T-cells) producing at least IFN-γ and another immune marker
Timeframe: At Day 0 and 21
Number of CD8 T-cells (per million CD8 T-cells) producing at least IL-2 and another immune marker
Timeframe: At Day 0 and 21
Number of CD8 T-cells (per million CD8 T-cells) producing at least TNF-α and another immune marker
Timeframe: At Day 0 and 21
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
 - Written informed consent obtained from the subject.
 
- Administration of other 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 vaccination
 
- Written informed consent obtained from the subject.
 - Free of an acute aggravation of the health status as established by clinical evaluation 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.
 - Male or female subjects who participated in the 104888 study (NCT00377585) and were enrolled in the >= 65 years age group or in the 18-40 years age group .
 
Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination
 - Planned administration of an influenza vaccine other than the study vaccines during the entire study period
 - Any vaccination against influenza since January 2007
 - Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
 - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
 - History of hypersensitivity to a previous dose of influenza vaccine
 - History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
 - Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests
 - Acute disease at the time of enrolment
 - Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
 - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period
 - Any medical conditions in which IM injections are contraindicated
 - Pregnant or lactating female, or planning to become pregnant or to discontinue contraceptive precautions.
 
Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
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.