Influenza Clinical Trial
Official title:
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
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.
This is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to 12 weeks (the investigational group, also referred to as the 2-month-old group) versus children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group). The study is not designed to achieve any preset statistical power, and no hypotheses will be tested. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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