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.
All participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively. A subset of the participants will receive a third vaccine injection (2010-2011 Northern Hemisphere \[NH\] seasonal trivalent influenza vaccine \[TIV\]) approximately 13 months after the first vaccination; additionally, a subset of participants' naïve to the swine-origin A/H1N1 strain will also receive one vaccine injection of the 2010-2011 NH seasonal TIV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
450
0.5 mL, Intramuscular on Day 0 and day 21 (all participants); and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)
0.5 mL, Intramuscular on Day 0 and day 21 (all participants), and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).
0.5 mL, Intramuscular on Day 0 and Day 21
Unnamed facility
Angers, France
Unnamed facility
Château-Gontier, France
Unnamed facility
Cherbourg, France
Unnamed facility
Équeurdreville-Hainneville, France
Unnamed facility
Laval, France
Unnamed facility
Tiercé, France
To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccine
Time frame: 21 days post-vaccination
To provide information concerning the safety in terms of solicited injection site and systemic reactions following vaccination with Swine A/H1N1 influenza vaccine
Time frame: 0 to7 days post-vaccination and entire study duration
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