At a glance
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Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2008-2009 Formulation)
In Brief
A Phase 4 clinical trial evaluating Influenza Virus Vaccine No Preservative: Pediatric Dose for Influenza and Orthomyxoviridae Infections. Completed, enrolled 32 participants across 1 site.
Detailed Summary
Primary Objective: To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study. Observational Objectives: To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children ≥ 6 months to \< 5 years of age. To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with ACIP recommendations, in children ≥ 6 months to \< 5 years of age.
Study Details
Timeline
Interventions
0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)