The study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine. Observational Objectives: * To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination. * To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in both study groups following each vaccination. * To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in both study groups.
This is a descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children who were given Fluzone® vaccine at 2 months of age (Study GRC27 NCT00858468)and those who never received influenza vaccine.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
242
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
Dayton, Ohio, United States
Unnamed facility
Pittsburgh, Pennsylvania, United States
Unnamed facility
Seattle, Washington, United States
Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.
Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.
Time frame: Day 28 Post-vaccination
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