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About
The aim of this study is to evaluate the safety and immunogenicity of Fluzone® Quadrivalent vaccine in participants aged 6 months to < 9 years at enrollment, divided into 2 age strata (6 months to < 36 months and 3 years to < 9 years)
Primary Objective:
Observational Objectives:
Full description
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.
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 information will be collected from Visit 1 to Visit 2, or Visit 3 for those subjects receiving 2 doses.
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 technique. For each influenza vaccine strain, pre- and post-vaccination geometric mean titers will be calculated.
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Interventional model
Masking
60 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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