Influenza Clinical Trial
Official title:
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine (2014-2015 Formulation)
The study will evaluate the safety and immunogenicity of the 2014-2015 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 2014-2015 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 2014-2015 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 Center for Biologics Evaluation and
Research (CBER) for further analysis by the WHO, the Centers for Disease Control and
Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation
recommendations for subsequent influenza vaccines.
Participants will be assigned to the appropriate age group based on the age at the time of
enrollment. Participants will receive a dose of Fluzone Quadrivalent vaccine, those for whom
2 doses of influenza vaccine are recommended per ACIP guidance, will receive a second dose
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 the study. Immunogenicity will be evaluated in all participants prior to
vaccination and at Day 28 after the final vaccination.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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