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Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines

Influenza Clinical Trial

Official title:
Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2017-2018 Formulations

Clinical Trial Summary

The aim of the study was to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone Quadrivalent vaccine in children 6 months to < 9 years of age, and in adults 18 to < 65 years of age, and to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.

Clinical Trial Description

All participants received 1 intramuscular dose of their assigned vaccine during Visit 1. For participants, for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of the same volume as the first dose was administered during Visit 2 (28 days after Visit 1). Solicited adverse reaction (AR) information was collected for 7 days following each vaccination. Unsolicited non-serious adverse event (AE) and serious adverse event (SAE) information was collected from Visit 1 to Visit 2 or from Visit 1 to Visit 3 for those participants receiving 2 doses of study vaccine. Immunogenicity was evaluated in all participants prior to vaccination on Day 0 (Visit 1) and after the final vaccination (Day 28 post-final vaccination for participants 6 months to < 9 years of age and Day 21 post-vaccination for participants ≥ 18 years of age). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03308825
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 4
Start date September 11, 2017
Completion date November 22, 2017
View Details
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