Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Subjects Aged 6 to 35 Months
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Enrollment
- 401
- Primary Endpoint
- Immunogenicity: To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccines
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief 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.
Detailed Description
All participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively. A subset of the participants eligible who received two half-doses of either formulation 1 or 2 will also be proposed to receive the 2010-2011 Northern Hemisphere (NH) seasonal Trivalent Influenza Vaccine (TIV) 13 months after the first vaccination as Follows: * Subjects less than 36 months at the time of TIV injection will receive two half-doses and additional sampling for immunogenicity assessment (one before the first TIV vaccination and one 21 days after last TIV vaccination). * Subjects aged more than 36 months at the time of TIV injection will receive a full TIV dose and additional sampling for immunogenicity assessment (one before TIV vaccination and one 21 days after TIV vaccination).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Immunogenicity: To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccines
Time Frame: 21 days post vaccination
Safety: To provide information concerning the safety in terms of solicited injection site and systemic reactions of Swine A/H1N1 influenza vaccines.
Time Frame: 0-7 days post-vaccination and entire study duration