drugset / Trial / NCT00430521
Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A)
RandomizedParallel-groupOpen-labelPrevention
Summary
The aim of the study is to assess the safety \& immunogenicity of a pandemic influenza vaccine administered at 2 different time points. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Timeline
- Start
- 2007-02-05
- Primary completion
- 2008-10-20
- Completion
- 2008-10-20
Publications
- Background Gillard P, Caplanusi A, Knuf M, Roman F, Walravens K, Moris P, Drame M, Schwarz TF. An assessment of prime-boost vaccination schedules with AS03A -adjuvanted prepandemic H5N1 vaccines: a randomized study in European adults. Influenza Other Respir Viruses. 2013 Jan;7(1):55-65. doi: 10.1111/j.1750-2659.2012.00349.x. Epub 2012 Mar 9.
- Background Schwarz TF, Horacek T, Knuf M, Damman HG, Roman F, Drame M, Gillard P, Jilg W. Single dose vaccination with AS03-adjuvanted H5N1 vaccines in a randomized trial induces strong and broad immune responsiveness to booster vaccination in adults. Vaccine. 2009 Oct 23;27(45):6284-90. doi: 10.1016/j.vaccine.2009.01.040.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pandemic influenza vaccine (GSK1119711A)-formulation 1 | Vaccine | — | Intramuscular |
| Subject | Pandemic influenza vaccine (GSK1119711A)-formulation 2 | Vaccine | — | Intramuscular |