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GSK A/turkey H5N1 Influenza vaccine · 1 trial · 1 indication
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (\<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.
A seroprotected subject against the A/turkey virus strain was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.
HI antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10.
| Arm | Type | Description |
|---|---|---|
| A/turkey H5N1 influenza Formulation A Group | EXPERIMENTAL | Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| A/turkey H5N1 influenza Formulation B1 Group | EXPERIMENTAL | Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| A/turkey H5N1 influenza Formulation B2 Group | EXPERIMENTAL | Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| A/turkey H5N1 influenza Formulation C1 Group | EXPERIMENTAL | Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| A/turkey H5N1 influenza Formulation C2 Group | EXPERIMENTAL | Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| A/turkey H5N1 influenza Formulation D1 Group | EXPERIMENTAL | Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| A/turkey H5N1 influenza Formulation D2 Group | EXPERIMENTAL | Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| A/turkey H5N1 influenza Formulation E1 Group | EXPERIMENTAL | Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| A/turkey H5N1 influenza Formulation E2 Group | EXPERIMENTAL | Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| GSK A/turkey H5N1 Influenza vaccine | BIOLOGICAL | One dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested. |
Inclusion Criteria: * Male and female adults 18 to 64 years of age at time of first vaccination, inclusive. * Written informed consent obtained from the subject. * Stable health status as defined by absence of a health event satisfying the definition of a SAE, or a change in an ongoing drug therapy...
GSK A/turkey H5N1 Influenza vaccine is an investigational vaccine being developed for the prevention of influenza, specifically targeting the H5N1 avian flu strain. It is currently in Phase 2 clinical development and has been studied in adults aged 18 to 64 years.
GSK A/turkey H5N1 Influenza vaccine is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's immunogenicity and safety in adults.
GSK A/turkey H5N1 Influenza vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the vaccine is not currently in any active clinical trials.
GSK A/turkey H5N1 Influenza vaccine has been studied in one completed Phase 2 clinical trial, NCT00771615, titled 'Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged 18-64 Years.' The trial enrolled 469 participants in the United States and Canada.
Yes, GSK A/turkey H5N1 Influenza vaccine is the same as GSK's Avian Flu Vaccine 1557484A. The clinical trial NCT00771615 refers to the vaccine by this alternative name, and it is being developed for the prevention of H5N1 avian influenza.