Woman and Man
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Extract
• To describe the injection site reactions and systemic safety profile during the 21 days following each of two primary series and one booster (as applicable) intramuscular (IM) injections in two age groups: subjects aged 18 to 60 years (adults) or >60 years (elderly). • To describe the immune response 21 days after each of two primary series IM injections in two age groups: subjects aged 18 to 60 years (adults) and >60 years (elderly). • To describe the antibody persistence at 6 or 15 months after the first vaccination and prior to the Clade 2 booster vaccination in two age groups: subjects aged 18 to 60 years (adults) or >60 years (elderly). • To describe the immune response 21 days after a booster vaccination administered at either 6 months (Clade 1 booster) or later (Clade 2 booster) after the first vaccination in two age groups: subjects aged 18 to 60 years or >60 years. • To describe any serious adverse events (SAEs) during the whole trial.
Inclusion criteria
- Vaccination of adults (18-60 years) and elderly (>60 years) with pandemic flu H5N1 vaccine