A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy Europeans Children Aged 6 to 35 Months
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 hemagglutination inhibition (HAI) method in a subset of participants who received two half-doses of either formulation 1 or 2. * To describe the immune response against the A/H1N1 strain using the HAI method 21 days after last vaccination with the 2010-2011 NH seasonal Trivalent Influenza Vaccine (TIV) administered 13 months after the first vaccination in a subset of subjects who received two half-doses of either t either formulation 1 or 2 of the A/H1N1 influenza vaccines as primary series. * To describe the safety profile of each vaccine in all participants.
Timeline
- Start
- 2009-09
- Primary completion
- 2011-01
- Completion
- 2011-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Influenza Virus Vaccine | Vaccine | 0.5 ml | — |
| Subject | Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant) | Vaccine | 0.5 ml | Intramuscular |
| Subject | Swine A/H1N1 influenza vaccine (split virion, inactivated) | Vaccine | 0.5 ml | Intramuscular |