Influenza Clinical Trial
Official title:
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone
vaccine.
Objective:
- To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in
a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization
Practices (ACIP) recommendations, in children 6 months to < 9 years of age.
Observational Objectives:
- To describe the immunogenicity of the 2012-2013 formulation of Fluzone vaccine,
administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in
children 6 months to < 9 years of age.
- To submit remaining available sera from subjects to the Center for Biologics Evaluation
and Research (CBER) for further analysis by the World Health Organization (WHO), the
Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration
(FDA) to support selection and recommendation of strains for subsequent years'
influenza vaccines.
All participants will receive Fluzone vaccine during Visit 1. For subjects receiving 2 doses
of influenza vaccine, per ACIP guidance, a second dose of Fluzone vaccine will be
administered during Visit 2.
Total duration of participation in the study is approximately 28 days for participants
receiving 1 dose and 56 days for those receiving 2 doses of Fluzone vaccine.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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