Primary Objective: To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. Secondary Objectives: * To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. * To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
520
Vaccine (infant dose)
Vaccine (children dose)
Vaccine (infant dose)
Vaccine (children dose)
Unnamed facility
Harrisburg, Arkansas, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Trumann, Arkansas, United States
Unnamed facility
Bellflower, California, United States
Unnamed facility
Downey, California, United States
Unnamed facility
Fountain Valley, California, United States
Unnamed facility
Paramount, California, United States
Unnamed facility
Owensboro, Kentucky, United States
Unnamed facility
Bossier City, Louisiana, United States
Unnamed facility
Shreveport, Louisiana, United States
...and 9 more locations
Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Time frame: Day 0 and Day 28 post-vaccination
Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Time frame: Day 28 post-vaccination
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Seroprotection was defined as participants achieving a post-dose antibody titers ≥40. Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Time frame: Day 28 post-vaccination
Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer \< 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10.
Time frame: Day 28 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.
Time frame: Day 0 to Day 7 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.
Time frame: Day 0 to Day 7 post-vaccination
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