A Study of Inactivated Swine-Origin A/H1N1 Influenza Vaccines in Healthy European Subjects Aged 3 to 17 Years
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 vaccines 21 days after each vaccination in all participants. * To describe the antibody persistence eight months after the first vaccine administration using HAI method, in a subset of participants 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 NH seasonal TIV administered approximately 13 months after the first vaccination in the subset of participants who received two injections. * To describe the safety profile of each vaccine in all participants.
Timeline
- Start
- 2009-08
- Primary completion
- 2010-09
- Completion
- 2010-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Influenza Virus Vaccine | Vaccine | 0.5 ml | — |
| Subject | Swine A/H1N1 influenza vaccine | Vaccine | 0.5 ml | Intramuscular |
| Subject | Swine A/H1N1 influenza vaccine | Vaccine | 0.5 ml | Intramuscular |