NCT03308825

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Influenza
• Flu

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone Quadrivalent vaccine	0.25 mL, Intramuscular
BIOLOGICAL	Fluzone Quadrivalent vaccine	0.5 mL, Intramuscular
BIOLOGICAL	Fluzone High-Dose vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2017-09-11
• Primary completion: 2017-11-22
• Completion: 2017-11-22
• First posted: 2017-10-13
• Last updated: 2022-03-29
• Results posted: 2018-12-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study