The purpose of this study is to assess the safety and immunogenicity of one dose of A/H1N1 non-adjuvanted pandemic vaccine to support registration of the vaccine in India. Primary Objective: * To describe the safety profile (injection site reactions and systemic events) of the vaccine within 21 days following vaccination, and serious adverse events throughout the study in all subjects Secondary Objectives: * To describe the immune response to the vaccine 21 days after vaccination by hemagglutination inhibition (HAI) testing in all subjects * To describe the antibody persistence 6 months after vaccination by HAI testing in all subjects.
Each study participant will receive one dose of the study vaccine on Day 0, provide pre- and post-vaccination blood samples at 21 and 180 days for immunogenicity testing and undergo safety follow-up for 6 months post-vaccination.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
0.5 mL, Intramuscular
Unnamed facility
Chandigarh, India
Unnamed facility
New Delhi, India
Unnamed facility
Pune, India
To provide information concerning the safety profile in terms of solicited injection site reactions, systemic events, and serious adverse events after administration of A/H1N1 pandemic influenza vaccine.
Time frame: 7 days post-vaccination and entire study duration
To provide information concerning the immune response to A/H1N1 pandemic influenza vaccine.
Time frame: 21 days post-vaccination
To provide information concerning antibody persistence 6 months after vaccination with A/H1N1 pandemic influenza vaccine.
Time frame: 6 months post-vaccination
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