RECRUITINGPhase 2INTERVENTIONAL

A Study to Learn About 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

About This Trial

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.

Who May Be Eligible (Plain English)

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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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).

Treatments Being Tested

BIOLOGICAL

Vaccine Candidate #1

Investigational influenza Vaccine

BIOLOGICAL

Vaccine Candidate #2

Investigational influenza Vaccine

BIOLOGICAL

Vaccine Candidate #3

Investigational Influenza Vaccine

BIOLOGICAL

Vaccine Candidate #4

Investigational Influenza Vaccine

BIOLOGICAL

Vaccine Candidate #5

Investigational Influenza Vaccine

BIOLOGICAL

Vaccine Candidate #6

Investigational Influenza Vaccine

BIOLOGICAL

TIV1 or TIV2

Licensed influenza vaccine

Locations (15)

AMR Clinical

Mobile, Alabama, United States

Diablo Clinical Research, LLC d/b/a Flourish Research

Walnut Creek, California, United States

Clinical Research Consulting, LLC

Milford, Connecticut, United States

George Washington Medical Faculty Associates

Washington D.C., District of Columbia, United States

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Palm Springs Community Health Center

Miami Lakes, Florida, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

East-West Medical Research Institute

Honolulu, Hawaii, United States

AMR Clinical

Kansas City, Missouri, United States

Rochester Clinical Research, LLC

Rochester, New York, United States

DM Clinical Research - Philadelphia

Philadelphia, Pennsylvania, United States

SMS Clinical Research LLC

Mesquite, Texas, United States

DM Clinical Research

Tomball, Texas, United States

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, United States

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia, United States