Influenza Clinical Trial
Official title:
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
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.
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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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