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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...
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The GSK A/turkey H5N1 Influenza vaccine is an investigational vaccine developed by GSK plc for protection against avian-origin H5N1 influenza. It is a vaccine candidate studied in healthy adults aged 18 to 64 years. GSK's avian flu vaccine is identified in trial records as 1557484A.
It is being developed for the prevention of influenza caused by the A/turkey H5N1 avian influenza strain. The vaccine is intended to protect people against H5N1 influenza infection. Its clinical program has studied immunization in healthy adult volunteers.
The vaccine is made by GSK plc, which trades under the ticker GSK. GSK developed and sponsored the clinical study of this avian influenza vaccine candidate. The company is listed as the developer of the A/turkey H5N1 Influenza vaccine.
The GSK A/turkey H5N1 Influenza vaccine is in Phase 2 development. It is an investigational vaccine and is not an approved product. The Phase 2 study evaluating its immunogenicity and safety has been completed.
The vaccine has been studied in one completed Phase 2 trial, NCT00771615, titled Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged 18-64 Years. The randomized, double-blind, controlled trial enrolled 469 healthy adults aged 18 to 64 in the United States and Canada.