NCT06507553

Study of Influenza Vaccines Containing an Additional H3 Antigen in Healthy Adult Participants 18 to 49 Years of Age and 60 Years of Age and Older

A Translational Phase I, Randomized, Parallel-group, Multi-arm Study to Evaluate Safety and Immunogenicity of an Influenza Vaccine Formulation Containing an Additional H3 Antigen in Healthy Adult Participants 18 to 49 Years of Age and 60 Years of Age and Older.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Study FBP00005 is planned to be a translational Phase I, randomized, modified double-blind, active-controlled, multi-center study to be conducted in 2 stages in approximately 400 adults, 18 to 49 years of age and ≥ 60 years of age, in Australia. The purpose of the study is to evaluate the safety and immunogenicity of an influenza vaccine formulation composed of the WHO-recommended virus strains plus an additional H3 strain, compared to formulations containing a single strain from each influenza virus subtype. Younger adults 18 to 49 years of age will be enrolled in Stage 1 and offered study vaccine formulations at the standard dose. Adults ≥ 60 years of age in Stage 2 will be offered study vaccine formulations at a higher dose. Enrollment of participants in Stage 2 will occur after review of, and be guided by, safety and immunogenicity results from Stage 1. The study duration will be approximately 3 weeks.

Conditions

• Influenza
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Trivalent-Darwin influenza vaccine	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
BIOLOGICAL	Augment-Tasmania influenza vaccine	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
BIOLOGICAL	TIV-2X Darwin influenza vaccine	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
BIOLOGICAL	Trivalent-Tasmania influenza vaccine	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Timeline

• Start date: 2024-08-12
• Primary completion: 2025-03-04
• Completion: 2025-03-04
• First posted: 2024-07-18
• Last updated: 2025-09-11

Locations

10 sites across 1 country: Australia