Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
H5N1 adjuvanted split virus vaccine · 1 trial · 2 indications
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
| Arm | Type | Description |
|---|---|---|
| H5N1 Adjuvanted Group | EXPERIMENTAL | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
| H5N1 Un-adjuvanted Group | ACTIVE_COMPARATOR | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
| Name | Type | Description |
|---|---|---|
| H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain) | BIOLOGICAL | Two doses of the GSK1562902A adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21. |
| H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain) | BIOLOGICAL | Two doses of the GSK1562902A non-adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21. |
| H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain) | BIOLOGICAL | Booster administration at Month 6 (and a second booster dose 21 days later for the un-adjuvanted group only) with an adjuvanted split virus pandemic influenza candidate vaccine containing the strain A/Indonesia/5/2005. |
Inclusion Criteria: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol * A male or female between, and including, 18 and 60 years of age at the time of the first vaccination. * Written informed consent obtained from the subject. * Healthy su...