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...
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The H5N1 adjuvanted split virus vaccine is an investigational pandemic influenza vaccine developed by GSK plc. It is a split virus vaccine that includes an adjuvant and is based on the A/Vietnam/1194/2004 strain. It is being studied for protection against H5N1 influenza in adults.
The H5N1 adjuvanted split virus vaccine is being developed for the prevention of influenza caused by the H5N1 virus. Its Phase 3 trial enrolled healthy adult volunteers in Hong Kong, Singapore, Taiwan, and Thailand. It is intended as a pandemic influenza vaccine rather than a seasonal flu vaccine.
GSK plc, which trades under the ticker GSK, is the developer of the H5N1 adjuvanted split virus vaccine. The Phase 3 study was conducted under GlaxoSmithKline Biologicals, with the vaccine also identified in the trial as GSK1562902A.
The H5N1 adjuvanted split virus vaccine is in Phase 3 development. Its single recorded Phase 3 trial, NCT00449670, is completed, and no trials are currently active. The vaccine is investigational and has not been established as an approved product.
The H5N1 adjuvanted split virus vaccine has been studied in one Phase 3 trial, NCT00449670, titled a study to assess consistency of immunogenicity of GlaxoSmithKline Biologicals' pandemic influenza vaccine (GSK1562902A) in adults. It enrolled 1,206 participants across Hong Kong, Singapore, Taiwan, and Thailand and is completed.