drugset / Trial / NCT01310413
Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age
RandomizedParallel-groupTriple-blindPrevention
Summary
This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccine GSK1557484A in children 6 months to \< 18 years of age.
Timeline
- Start
- 2011-03-07
- Primary completion
- 2011-07-21
- Completion
- 2014-01-26
Publications
- Background Izurieta P et al. (2018) Reactogenicity and safety of AS03B-adjuvanted H5N1 influenza vaccine in children: an open-label, one-way, crossover trial. Asian Biomed (Res Rev News). 11(4):359-364.
- Background Kosalaraksa P, Jeanfreau R, Frenette L, Drame M, Madariaga M, Innis BL, Godeaux O, Izurieta P, Vaughn DW. AS03B-adjuvanted H5N1 influenza vaccine in children 6 months through 17 years of age: a phase 2/3 randomized, placebo-controlled, observer-blinded trial. J Infect Dis. 2015 Mar 1;211(5):801-10. doi: 10.1093/infdis/jiu548. Epub 2014 Oct 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GSK1557484A | Vaccine | — | Intramuscular |