A Study To Learn About The Study Vaccine (Called Self-Amplifying Ribonucleic Acid (RNA)) For The Prevention of Influenza
Public ClinicalTrials.gov record NCT05227001. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05227001
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 440 participants
Conditions and interventions
Conditions
Interventions
- PF-07852352 Influenza saRNA 1 Biological
- PF-07836391 Influenza saRNA Biological
- PF-07836394 Influenza saRNA Biological
- PF-07836395 Influenza saRNA Biological
- PF-07836396 Influenza saRNA Biological
- PF-07867246 Influenza saRNA Biological
- Placebo Biological
- Quadrivalent influenza vaccine (QIV) Biological
- PF-07871987 Influenza saRNA Biological
- PF-07914705 Influenza saRNA Biological
- PF-07915048 Influenza saRNA Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 27, 2022
- Primary completion
- Aug 3, 2023
- Completion
- Aug 3, 2023
- Last update posted
- Mar 19, 2026
2022 – 2023
United States locations
- U.S. sites
- 24
- U.S. states
- 9
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Heart Rhythm Center | Phoenix | Arizona | 85016 | — |
| Hope Research Institute | Phoenix | Arizona | 85018 | — |
| The Pain Center of Arizona | Phoenix | Arizona | 85018 | — |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | — |
| Finlay Medical Research | Greenacres City | Florida | 33467 | — |
| Advanced Pharma CR, LLC | Miami | Florida | 33147 | — |
| Miami Clinical Research | Miami | Florida | 33155 | — |
| Mount Sinai Hospital | Miami Beach | Florida | 33140 | — |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | — |
| Pines Care Research Center, LLC | Pembroke Pines | Florida | 33024 | — |
| Pinnacle Health Care Center | Pembroke Pines | Florida | 33024 | — |
| Comprehensive Cardiology Consultants | Pembroke Pines | Florida | 33028 | — |
| Great Lakes Clinical Trials - Andersonville | Chicago | Illinois | 60640 | — |
| Pioneer Heart Institute | Lincoln | Nebraska | 68506 | — |
| Velocity Clinical Research, Omaha | Omaha | Nebraska | 68134 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| SUNY Upstate Medical University Global Health Laboratory | Syracuse | New York | 13210 | — |
| SUNY Upstate Medical University Institute for Global Health | Syracuse | New York | 13215 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13215 | — |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | — |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | — |
| Benchmark Research | Austin | Texas | 78705 | — |
| Eric S. Tiblier, MD | Austin | Texas | 78705 | — |
| DM Clinical Research, Martin Diagnostic Clinic | Tomball | Texas | 77375 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05227001, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 19, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05227001 live on ClinicalTrials.gov.