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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
394
0.25 mL, Intramuscular
0.25 mL, Intramuscular
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Marietta, Georgia, United States
Unnamed facility
Durham, North Carolina, United States
Unnamed facility
Akron, Ohio, United States
Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.
Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.
Time frame: Day 0 to Day 7 post-vaccination
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Unnamed facility
Dayton, Ohio, United States
Unnamed facility
Pittsburgh, Pennsylvania, United States
Unnamed facility
Norfolk, Virginia, United States
Unnamed facility
Seattle, Washington, United States