Influenza Clinical Trial
Official title:
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 Formulation)
The aim of this study is to evaluate the safety and immunogenicity of Fluzone® Quadrivalent
vaccine in participants aged 6 months to < 9 years at enrollment, divided into 2 age strata
(6 months to < 36 months and 3 years to < 9 years)
Primary Objective:
- To describe the safety of the 2013-2014 formulation of Fluzone Quadrivalent 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 2013-2014 formulation of Fluzone Quadrivalent
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 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
formulation recommendations for subsequent influenza vaccines.
Participants will be assigned to the appropriate age group (6 months to < 36 months of age
or 3 years to < 9 years of age) based on the subject's age at the time of enrollment.
Solicited adverse event (AE) information will be collected for 7 days after each
vaccination, unsolicited AE information will be collected from Visit 1 to Visit 2, or to
Visit 3 for those subjects receiving 2 doses. Serious adverse event information will be
collected from Visit 1 to Visit 2, or Visit 3 for those subjects receiving 2 doses.
Immunogenicity will be evaluated in all subjects prior to vaccination on Day 0 (Visit 1) and
at Day 28 after the final vaccination using the hemagglutination inhibition technique. For
each influenza vaccine strain, pre- and post-vaccination geometric mean titers will be
calculated.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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