drugset / Trial / NCT00989287
Immunogenicity and Safety Study of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults
RandomizedParallel-groupTriple-blindPrevention
Summary
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A in adults aged 18 to 60 years.
Timeline
- Start
- 2009-10-07
- Primary completion
- 2009-10-09
- Completion
- 2010-10-26
Publications
- Background Roman F, Clement F, Dewe W, Walravens K, Maes C, Willekens J, De Boever F, Hanon E, Leroux-Roels G. Effect on cellular and humoral immune responses of the AS03 adjuvant system in an A/H1N1/2009 influenza virus vaccine administered to adults during two randomized controlled trials. Clin Vaccine Immunol. 2011 May;18(5):835-43. doi: 10.1128/CVI.00480-10. Epub 2011 Mar 30.
- van der Most RG, Clement F, Willekens J, Dewe W, Walravens K, Vaughn DW, Leroux-Roels G. Long-Term Persistence of Cell-Mediated and Humoral Responses to A(H1N1)pdm09 Influenza Virus Vaccines and the Role of the AS03 Adjuvant System in Adults during Two Randomized Controlled Trials. Clin Vaccine Immunol. 2017 Jun 5;24(6):e00553-16. doi: 10.1128/CVI.00553-16. Print 2017 Jun.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GSK2340269A | Vaccine | — | Intramuscular |
| Subject | GSK2340272A | Vaccine | — | Intramuscular |