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.
All participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively. A subset of children and adolescents participants eligible for the antibody persistence evaluation were sampled 8 months after the first vaccination, they will also be proposed to receive the 2010-2011 Northern Hemisphere (NH) seasonal Trivalent Influenza Vaccine (TIV) 13 months after the first vaccination. Immunogenicity response will be evaluated before vaccination and 21 days after vaccination with TIV, respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
303
0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a 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 a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).
0.5 mL, Intramuscular on Day 0 and day 21
Unnamed facility
Espoo, Finland
Unnamed facility
Helsinki, Finland
Unnamed facility
Helsinki, Finland
Unnamed facility
Jarvenpaa, Finland
Unnamed facility
Kokkola, Finland
Unnamed facility
Kotka, Finland
Unnamed facility
Kuopio, Finland
Unnamed facility
Lahti, Finland
Unnamed facility
Oulu, Finland
Unnamed facility
Pori, Finland
...and 5 more locations
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 and unsolicited adverse events) of Swine A/H1N1 influenza vaccines.
Time frame: 0-7 days post-vaccination and entire study duration
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