Influenza Clinical Trial
Official title:
Safety and Immunogenicity of the 2015-2016 Formulation of Fluzone® Quadrivalent (Influenza Vaccine) Among Healthy Children
The study will evaluate the safety and immunogenicity of the 2015-2016 formulation of
Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with
the Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6
months to < 9 years of age.
Objective:
- To describe the safety of the 2015-2016 formulation of Fluzone Quadrivalent vaccine,
administered in a 1- or 2-dose schedule, in accordance with ACIP recommendations, in
children 6 months to < 9 years of age.
Observational objectives:
- To describe the immunogenicity of the 2015-2016 formulation of Fluzone Quadrivalent
vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP
recommendations, in children 6 months to < 9 years of age.
- To submit available sera from each subject to CBER for further analysis by the WHO, the
CDC, and the FDA to support formulation recommendations for subsequent influenza
vaccines.
Study participants will be assigned to the appropriate age group (6 months to < 36 months of
age or 3 years to < 9 years of age) based on the subject's age at the time of enrollment.
Participants aged 6 months to < 36 months will receive a 0.25 mL dose of Fluzone
Quadrivalent vaccine and those aged 3 years to < 9 years will receive a 0.5 mL dose of
Fluzone Quadrivalent vaccine. Participants, for whom 2 doses of influenza vaccine are
recommended per ACIP guidance, will receive a second dose of Fluzone Quadrivalent vaccine
during Visit 2 (28 days after Visit 1).
Solicited adverse event (AE) information will be collected for 7 days after each
vaccination, unsolicited AE information will be collected from Visit 1 to Visit 2 or to
Visit 3 for those subjects receiving 2 doses. Serious adverse event (SAE) information will
be collected from Visit 1 to Visit 2 or Visit 3, as appropriate.
Immunogenicity will be evaluated in all subjects prior to vaccination on Day 0 (Visit 1) and
at Day 28 after the final vaccination using the hemagglutination inhibition (HAI) technique.
For each influenza vaccine strain, pre- and post-vaccination geometric mean titers (GMTs)
will be calculated.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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