Influenza Clinical Trial
Official title:
Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2005-2006 Formulation)
To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for
Disease Control and Prevention (CDC), and the World Health Organization (WHO) for
characterization of circulating influenza strains.
Observational Objectives:
To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, 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 2005-2006 pediatric formulation of Fluzone vaccine,
administered in a two-dose schedule in accordance with the Package Insert, in children aged
≥ 6 months to < 36 months.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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