MedTrace Logo

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

NCT06507553 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-09-11

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-12
Primary Completion
2025-03-04
Completion
2025-03-04

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06507553 on ClinicalTrials.gov