drugset / Trial / NCT05227001

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

NCT05227001

Phase 1 Completed 440 enrolled Pfizer
RandomizedSequentialQuadruple-blindPrevention

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.

Timeline

Start
2022-04-28
Primary completion
2023-08-04
Completion
2023-08-04

Drugs

EvaluationDrugModalityDoseRoute
Subject PF-07836391 Unknown Intramuscular
Subject PF-07836394 Unknown Intramuscular
Subject PF-07836395 Unknown Intramuscular
Subject PF-07836396 Unknown Intramuscular
Subject PF-07852352 Unknown Intramuscular
Subject PF-07867246 Unknown Intramuscular
Subject PF-07871987 Unknown Intramuscular
Subject PF-07914705 Unknown Intramuscular
Subject PF-07915048 Unknown Intramuscular
Comparator Quadrivalent influenza vaccine Vaccine Intramuscular

Indications