Influenza Clinical Trial
Official title:
Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Influenza Virus Vaccine Fluzone® 2004-2005
To describe the safety of the 2004-2005 pediatric formulation of the inactivated,
split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with
the Package Insert, in children aged ≥ 6 months to < 36 months.
To describe the immunogenicity of the 2004-2005 inactivated, split-virion influenza vaccine
Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in
children aged ≥ 6 months to < 36 months
To provide the Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO). ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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