NCT06641180

Study to Evaluate Immunogenicity and Safety of a High-Dose Influenza Vaccine in Adults 50 Through 64 Years of Age

A Phase 3, Randomized, Modified Double-blind, 2-arm Study to Evaluate the Immunogenicity and Safety of High-Dose Inactivated Influenza Vaccine (IIV-HD) Compared With a Standard-dose Inactivated Influenza Vaccine (IIV-SD) in Participants 50 Through 64 Years of Age.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,180 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 50 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate Immunogenicity and Safety of a High-Dose (HD) Influenza Vaccine (IV) in Adults 50 through 64 Years of Age.

Detailed description

The study duration will be approximately 180 days (+ 14 days).

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	High-Dose trivalent influenza vaccine (Split virion, Inactivated)	Liquid suspension for intramuscular injection
BIOLOGICAL	Standard-dose trivalent influenza vaccine (Split virion, Inactivated)	Liquid suspension for intramuscular injection

Timeline

• Start date: 2024-11-04
• Primary completion: 2025-01-28
• Completion: 2025-06-24
• First posted: 2024-10-15
• Last updated: 2025-12-03

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study