mRNA vaccines against influenza in adults
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MRNA VACCINES AGAINST INFLUENZA IN ADULTS 18 YEARS OF AGE AND OLDER
This research will test single-dose mRNA flu vaccines in healthy adults to see if they are safe and trigger an immune response.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 770 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 15 sites (Mobile, Alabama and 14 other locations) |
| Trial ID | NCT07431853 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial gives each healthy adult participant a single dose of one experimental mRNA influenza vaccine or a licensed comparator and follows them for about six months. Safety is monitored and blood samples are collected at three scheduled visits to measure immune responses, with a nasal swab taken at the first visit. Multiple vaccine candidates are being compared to understand which formulations produce the strongest antibody response and acceptable safety profiles. The trial is sponsored by a major pharmaceutical company and conducted at several U.S. clinical sites.
Who should consider this trial
Good fit: Healthy adults aged 18 years or older who are medically stable and meet screening criteria are ideal candidates for this study.
Not a fit: People who are not medically healthy or who had influenza, a flu vaccine, or antiviral treatment within the past five months are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, these mRNA flu vaccines could provide faster development and potentially stronger or more flexible protection against influenza than current vaccines.
How similar studies have performed: mRNA vaccines were highly successful for COVID-19 and early-phase mRNA influenza studies have shown promising immune responses, but large-scale effectiveness for flu is not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria • Healthy and medically stable participants who are determined by medical history, physical examination (if clinically required), and clinical judgment of the investigator to be eligible for inclusion in the study. Exclusion Criteria * Tested positive for influenza ≤5 months (150 days) prior to Visit 1 (Day 1). * Vaccination with any investigational or licensed influenza vaccine ≤5 months (150 days) before Visit 1 (Day 1). * Receipt of antiviral therapies for influenza (eg, Tamiflu) ≤5 months (150 days) prior to Visit 1 (Day 1).
Where this trial is running
Mobile, Alabama and 14 other locations
- AMR Clinical — Mobile, Alabama, United States (Recruiting)
- Diablo Clinical Research, LLC d/b/a Flourish Research — Walnut Creek, California, United States (Recruiting)
- Clinical Research Consulting, LLC — Milford, Connecticut, United States (Recruiting)
- George Washington Medical Faculty Associates — Washington D.C., District of Columbia, United States (Recruiting)
- Indago Research & Health Center, Inc — Hialeah, Florida, United States (Recruiting)
- Palm Springs Community Health Center — Miami Lakes, Florida, United States (Recruiting)
- Clinical Research Atlanta — Stockbridge, Georgia, United States (Recruiting)
- East-West Medical Research Institute — Honolulu, Hawaii, United States (Recruiting)
- AMR Clinical — Kansas City, Missouri, United States (Recruiting)
- Rochester Clinical Research, LLC — Rochester, New York, United States (Recruiting)
- DM Clinical Research - Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- SMS Clinical Research LLC — Mesquite, Texas, United States (Recruiting)
- DM Clinical Research — Tomball, Texas, United States (Recruiting)
- J. Lewis Research, Inc. / Foothill Family Clinic — Salt Lake City, Utah, United States (Recruiting)
- Charlottesville Medical Research Center, LLC — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.