Approval Probability
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Adjusted LOA
ML Risk
Pandemic influenza vaccine GSK1562902A · 1 trial · 1 indication
Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005.
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005.
Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005.
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005.
Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1).
Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1).
GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
| Arm | Type | Description |
|---|---|---|
| GSK1562902A M6 Group | EXPERIMENTAL | Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) and boosted 6 months (M6) after primary vaccination with one dose of Pandemic influenza candidate vaccine (GSK1562902A) in study 109630 (NCT00449670), administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. |
| GSK1562902A M12 Group | EXPERIMENTAL | Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. |
| GSK1562902A M36 Group | EXPERIMENTAL | Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| Pandemic influenza vaccine GSK1562902A | BIOLOGICAL | IM administration |
Inclusion Criteria: * Subjects who completed participation in primary phase of this study. * 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. * Healthy subjects as ...
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Pandemic influenza vaccine GSK1562902A is an investigational vaccine developed by GSK plc for protection against influenza. It is a vaccine candidate studied in a Phase 3 clinical trial evaluating immunogenicity under different boosting vaccination schedules. It has been tested in healthy adult volunteers.
Pandemic influenza vaccine GSK1562902A is being developed for the prevention of influenza. Its clinical program has studied immune responses to the vaccine in healthy adults aged 19 years and older under different boosting schedules. It is intended for use against pandemic influenza.
Pandemic influenza vaccine GSK1562902A is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals conducted the clinical development of this pandemic influenza vaccine candidate.
Pandemic influenza vaccine GSK1562902A is in Phase 3 clinical development. It is an investigational vaccine and is not described as approved. The Phase 3 trial evaluating its immunogenicity at different boosting vaccination schedules has been completed.
Pandemic influenza vaccine GSK1562902A has been studied in the Phase 3 trial NCT00652743, titled Immunogenicity of GSK Biologicals' Pandemic Influenza Vaccine (GSK1562902A) at Different Boosting Vaccination Schedules. The trial enrolled 845 participants across Hong Kong, Singapore, Taiwan, and Thailand and is completed.
The Phase 3 trial NCT00652743 was a randomized, controlled study of 845 healthy volunteers aged 19 years and older, conducted in Hong Kong, Singapore, Taiwan, and Thailand. It evaluated the immunogenicity of GSK1562902A under different boosting vaccination schedules and has been completed.