Flu Vaccine for Influenza

Recruiting at23 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Sanofi Pasteur, a Sanofi Company

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

This trial is for adults aged 50 or older who are in good health. Women must be postmenopausal, surgically sterile, or willing to use effective contraception. Participants need a negative pregnancy test before receiving the study vaccine.

Inclusion Criteria

I agree to use effective birth control or abstain from sex starting 4 weeks before until 12 weeks after the treatment.

I am 50 years old or older.

I am not able to have children because I am postmenopausal or have been surgically sterilized.

Treatment Details

Interventions

• Hexavalent Influenza mRNA Vaccine (Cancer Vaccine)

Trial Overview The study tests different formulations of a hexavalent influenza mRNA vaccine against standard and high-dose quadrivalent flu vaccines. It measures safety and immune response after one intramuscular injection in participants.

Participant Groups

Group I: Group 9 - TIV mRNA-HA Vaccine 2 Experimental Treatment 1 Intervention

Participants will receive single dose of TIV mRNA-HA Vaccine 2

Group II: Group 8 - TIV mRNA-NA Experimental Treatment 1 Intervention

Participants will receive a single dose of TIV mRNA-NA

Group III: Group 7 - TIV mRNA-HA Vaccine 1 Experimental Treatment 1 Intervention

Participants will receive a single dose of TIV mRNA-HA Vaccine 1

Group IV: Group 6 - Hexavalent (Combination 6) Experimental Treatment 2 Interventions

Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 6)

Group V: Group 5 - Hexavalent (Combination 5) Experimental Treatment 2 Interventions

Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 5)

Group VI: Group 4 - Hexavalent (Combination 4) Experimental Treatment 2 Interventions

Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 4)

Group VII: Group 3 - Hexavalent (Combination 3) Experimental Treatment 2 Interventions

Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 3)

Group VIII: Group 2 - Hexavalent (Combination 2) Experimental Treatment 2 Interventions

Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 2)

Group IX: Group 1 - Hexavalent (Combination 1) Experimental Treatment 2 Interventions

Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 1)

Group X: Group 10 - QIV-SD Active Control 1 Intervention

Participants will receive single dose of QIV-SD vaccine (for participants 50 to 64 years of age only)

Group XI: Group 11 - QIV-HD Active Control 1 Intervention

Participants will receive single dose of QIV-HD vaccine

Who Is Running the Clinical Trial?

Sanofi Pasteur, a Sanofi Company

Lead Sponsor

Trials

429

Recruited

6,140,000+

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences