drugset / Trial / NCT00985673
Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine in Adults
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A when co-administered with the seasonal flu vaccine in adults 19 to 40 years of age.
Timeline
- Start
- 2009-10-01
- Primary completion
- 2009-12-28
- Completion
- 2010-12-29
Publications
- Friel D, Co M, Ollinger T, Salaun B, Schuind A, Li P, Walravens K, Ennis FA, Vaughn DW. Non-neutralizing antibody responses following A(H1N1)pdm09 influenza vaccination with or without AS03 adjuvant system. Influenza Other Respir Viruses. 2021 Jan;15(1):110-120. doi: 10.1111/irv.12780. Epub 2020 Sep 5.
- Langley JM, Frenette L, Chu L, McNeil S, Halperin S, Li P, Vaughn D. A randomized, controlled non-inferiority trial comparing A(H1N1)pmd09 vaccine antigen, with and without AS03 adjuvant system, co-administered or sequentially administered with an inactivated trivalent seasonal influenza vaccine. BMC Infect Dis. 2012 Oct 30;12:279. doi: 10.1186/1471-2334-12-279.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GSK2340273A | Vaccine | — | Intramuscular |
| Subject | GSK2340274A | Vaccine | — | Intramuscular |
| Subject | Seasonal trivalent influenza vaccine (TIV) | Vaccine | — | Intramuscular |