NCT06744205

A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older

A Phase I/II, Randomized, Modified Double-blind Study to Investigate the Safety and Immunogenicity of Different Doses of Hexavalent Influenza mRNA HA + mRNA NA Vaccine in Adult Participants 50 Years of Age and Older

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,162 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of different formulations of a hexavalent influenza messenger ribonucleic acid (mRNA) vaccine composed of differing dose levels of trivalent (TIV) mRNA hemagglutinin (HA) in combination with TIV mRNA-neuraminidase (NA) compared to an active control ((Fluzone standard-dose quadrivalent influenza vaccine (QIV-SD) or Fluzone high-dose quadrivalent influenza vaccine (QIV-HD) in adults 50 years of age and older.

Detailed description

Study details include the following: * Study Duration: approximately 12 months for each participant * Treatment: 1 injection of hexavalent vaccine, trivalent vaccine, or active control * Visit frequency: Day (D) 01, D03, D09, D29, and D181; D366 (telephone call) * Dose escalation with sequential enrollment of sentinel cohorts followed by parallel enrollment of the main cohort

Conditions

• Influenza
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1	* Pharmaceutical form: solution for injection in a vial * Route of administration: Intramuscular injection
BIOLOGICAL	TIV mRNA-neuraminidase (NA)	* Pharmaceutical form: solution for injection in a vial * Route of administration: Intramuscular injection
BIOLOGICAL	TIV mRNA-HA Vaccine 2	* Pharmaceutical form: solution for injection in a vial * Route of administration: Intramuscular injection
BIOLOGICAL	Quadrivalent Influenza Standard Dose Vaccine	* Pharmaceutical form: Liquid suspension for injection in pre-filled syringe * Route of administration: Intramuscular injection
BIOLOGICAL	Quadrivalent Influenza Vaccine High Dose	* Pharmaceutical form: Liquid suspension for injection in pre-filled syringe * Route of administration: Intramuscular injection

Timeline

• Start date: 2025-01-06
• Primary completion: 2026-04-16
• Completion: 2026-04-16
• First posted: 2024-12-20
• Last updated: 2025-05-30

Locations

24 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study