A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy European Adults and the Elderly
Summary
The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration. Primary objectives: * To describe the immune response to study vaccine 21 days after each vaccination. * To describe the antibody persistence 8 months after the first vaccine administration using hemagglutination inhibition (HAI) method in a randomized subset of adult subjects who received two injections. * To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 Northern Hemisphere (NH) seasonal trivalent influenza vaccine (TIV) administered 13 months after the first vaccination in a subset subjects who received the A/H1N1 influenza vaccine and in subjects naïve to the swine origin A/H1N1 strain. * To describe the safety profiles of study vaccines in all participants.
Timeline
- Start
- 2009-08
- Primary completion
- 2010-12
- Completion
- 2011-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 2010-2011 NH seasonal trivalent influenza vaccine | Vaccine | 0.5 ml | — |
| Subject | Swine A/H1N1 influenza vaccine (split virion, inactivated) | Vaccine | 0.5 ml | Intramuscular |