This study is designed to describe the immunogenicity of a pandemic A/H1N1 influenza vaccine in healthy adults given a lower vaccine dose and in a similar group given a full dose of the vaccine. The primary objective is to describe describe the immune response of the inactivated, split-virion swine-origin A/H1N1 influenza vaccine without adjuvant.
All participants will receive a single dose of study vaccine and will also be monitored for serious adverse events and adverse events of special interest occurring from Days 0 to 21 and at 6 months post-vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
202
0.3 mL, Intramuscular (IM)
0.5 mL, Intramuscular (IM)
Unnamed facility
Rennes, France
Unnamed facility
Rueil-Malmaison, France
To provide information concerning the immunogenicity in terms of anti-hemagglutinin (HA) antibody titers against non-adjuvanted pandemic A/H1N1 influenza vaccine.
Time frame: 21 days post-vaccination
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