A Study to Learn About mRNA Vaccines Against Influenza in Adults

Purpose

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.

Condition

  • Healthy Adults

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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).

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
A 		mRNA influenza vaccine candidate #1 as a single intramuscular (IM) injection on Day 1.
  • Biological: Vaccine Candidate #1
    Investigational influenza Vaccine
Experimental
B 		mRNA influenza vaccine candidate #2 as a single IM injection on Day 1.
  • Biological: Vaccine Candidate #2
    Investigational influenza Vaccine
Experimental
C 		mRNA influenza vaccine candidate #3 as a single IM injection on Day 1.
  • Biological: Vaccine Candidate #3
    Investigational Influenza Vaccine
Experimental
D 		mRNA influenza vaccine candidate #4 as a single IM injection on Day 1.
  • Biological: Vaccine Candidate #4
    Investigational Influenza Vaccine
Experimental
E 		mRNA influenza vaccine candidate #5 as a single IM injection on Day 1.
  • Biological: Vaccine Candidate #5
    Investigational Influenza Vaccine
Experimental
F 		mRNA influenza vaccine candidate #6 as a single IM injection on Day 1.
  • Biological: Vaccine Candidate #6
    Investigational Influenza Vaccine
Active Comparator
G 		Licensed influenza vaccine (TIV1 or TIV2) as a single IM injection.
  • Biological: TIV1 or TIV2
    Licensed influenza vaccine

Recruiting Locations

Diablo Clinical Research, LLC d/b/a Flourish Research
Walnut Creek, California 94598

Clinical Research Consulting, LLC
Milford, Connecticut 06460

George Washington Medical Faculty Associates
Washington D.C., District of Columbia 20037

Indago Research & Health Center, Inc
Hialeah, Florida 33012

Palm Springs Community Health Center
Miami Lakes, Florida 33014

Clinical Research Atlanta
Stockbridge, Georgia 30281

East-West Medical Research Institute
Honolulu, Hawaii 96814

Rochester Clinical Research, LLC
Rochester, New York 14609

DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania 19107

SMS Clinical Research LLC
Mesquite, Texas 75149

DM Clinical Research
Tomball, Texas 77375

J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah 84109

Charlottesville Medical Research Center, LLC
Charlottesville, Virginia 22911

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com