At a glance
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Proof of Concept Study of the Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005 Among Healthy Children 2 Months vs 6 Months of Age
In Brief
A Phase 2 clinical trial evaluating Influenza virus vaccine (2004-2005 Formulation) for Influenza. Completed, enrolled 394 participants across 8 sites.
Detailed Summary
Primary Objective: To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups. Observational Objective: To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.
Study Details
Timeline
Interventions
0.25 mL, Intramuscular
0.25 mL, Intramuscular