Approval Probability
TA Base Rate
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 ...
Pandemic influenza vaccine GSK1562902A is an investigational vaccine being developed for influenza, specifically as a pandemic influenza vaccine. It is intended to provide immunity against pandemic influenza strains. The vaccine is currently in Phase 3 clinical development and is being studied in healthy adult volunteers aged 19 years and older.
Pandemic influenza vaccine GSK1562902A is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the vaccine's immunogenicity and safety for pandemic influenza prevention.
Pandemic influenza vaccine GSK1562902A is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed, evaluating different boosting vaccination schedules for the vaccine in healthy adults.
Pandemic influenza vaccine GSK1562902A has one completed Phase 3 clinical trial, registered as NCT00652743. This trial, titled 'Immunogenicity of GSK Biologicals' Pandemic Influenza Vaccine (GSK1562902A) at Different Boosting Vaccination Schedules,' enrolled 845 participants across Hong Kong, Singapore, Taiwan, and Thailand.
Yes, Pandemic influenza vaccine GSK1562902A is classified as a monoclonal antibody modality. Despite being referred to as a vaccine, its modality is listed as a monoclonal antibody, which is a type of biologic drug designed to target specific antigens. It is being studied for influenza prevention.