NCT05227001

A Study To Learn About The Study Vaccine (Called Self-Amplifying Ribonucleic Acid (RNA)) For The Prevention of Influenza

A PHASE 1, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF SELF-AMPLIFYING RNA VACCINE PREPARATIONS AGAINST INFLUENZA IN HEALTHY INDIVIDUALS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 440 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to learn about the safety and effects of the study vaccine for the potential prevention of influenza. The study vaccine is called Self-Amplifying Ribonucleic Acid vaccine (saRNA vaccine). This study is seeking participants who: * Are between the age of 18 to 49 years old. * Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Are healthy as determined by medical history, physical examinations, and the study doctor. * For male participants, can father children and willing to use an acceptable method of contraception. Female participants who are not of childbearing potential; or male participant not able to father children. * Are capable of giving signed informed consent. Participants will receive either the saRNA vaccine, a licensed Influenza Vaccine (QIV) or a placebo. Participants will not know which vaccine they receive in advance. A placebo does not have any medicine in it but looks just like the study medicine. Participants will receive the study vaccines as a single shot in the arm. We will compare participant experiences to help us determine if the saRNA vaccine is safe and effective. Participants will take part in this study for 6 months. During this time, they will receive the study vaccine and participate in follow-up visits.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	PF-07852352 Influenza saRNA 1	Intramuscular injection
BIOLOGICAL	PF-07836391 Influenza saRNA	Intramuscular injection
BIOLOGICAL	PF-07836394 Influenza saRNA	Intramuscular injection
BIOLOGICAL	PF-07836395 Influenza saRNA	Intramuscular injection
BIOLOGICAL	PF-07836396 Influenza saRNA	Intramuscular injection
BIOLOGICAL	PF-07867246 Influenza saRNA	Intramuscular injection
BIOLOGICAL	Placebo	Intramuscular injection
BIOLOGICAL	Quadrivalent influenza vaccine (QIV)	Intramuscular injection
BIOLOGICAL	PF-07871987 Influenza saRNA	Intramuscular injection
BIOLOGICAL	PF-07914705 Influenza saRNA	Intramuscular injection
BIOLOGICAL	PF-07915048 Influenza saRNA	Intramuscular injection

Timeline

• Start date: 2022-04-28
• Primary completion: 2023-08-04
• Completion: 2023-08-04
• First posted: 2022-02-07
• Last updated: 2026-03-20

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated drug study