Study to Evaluate Immunogenicity and Safety of a High-Dose Influenza Vaccine in Adults 50 Through 64 Years of Age
NCT06641180 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1180
Last updated 2025-12-03
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.
Conditions
Interventions
- 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
Sponsors & Collaborators
-
Sanofi Pasteur, a Sanofi Company
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-11-04
- Primary Completion
- 2025-01-28
- Completion
- 2025-06-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
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