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
Pfizer
Summary
The purpose of this study is to learn about safety in participants taking the study vaccine (mRNA-based vaccine) and the ability of the study vaccine to trigger the body's immune response, targeting the flu virus (influenza virus). This study is seeking healthy participants 18 years of age or older. All participants in this study will receive only 1 dose in their arm, to deliver one of the experimental flu vaccines or one of the approved flu vaccines used for comparison. Participants will take part in this study for about 6 months, and participants will need to visit the study site at least 3 times. A blood sample will be taken at each of the 3 planned study visits and a swab from inside the nose will be taken at the first study visit.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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).
Interventions
- BiologicalVaccine Candidate #1
Investigational influenza Vaccine
- BiologicalVaccine Candidate #2
Investigational influenza Vaccine
- BiologicalVaccine Candidate #3
Investigational Influenza Vaccine
- BiologicalVaccine Candidate #4
Investigational Influenza Vaccine
- BiologicalVaccine Candidate #5
Investigational Influenza Vaccine
- BiologicalVaccine Candidate #6
Investigational Influenza Vaccine
- BiologicalTIV1 or TIV2
Locations (15)
- AMR ClinicalMobile, Alabama
- Diablo Clinical Research, LLC d/b/a Flourish ResearchWalnut Creek, California
- Clinical Research Consulting, LLCMilford, Connecticut
- George Washington Medical Faculty AssociatesWashington D.C., District of Columbia
- Indago Research & Health Center, IncHialeah, Florida
- Palm Springs Community Health CenterMiami Lakes, Florida