A Study About Modified RNA Vaccines Against Influenza in Healthy Adults

Last updated: February 12, 2025
Sponsor: Pfizer
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

Quadrivalent Influenza Vaccine (QIV)

Influenza ModRNA Vaccine

Clinical Study ID

NCT06436703
C4781013
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to learn if modified RNA (modRNA) vaccines for the prevention of influenza are:

  • safe; and

  • how these vaccines produce an immune response in generally healthy adults. Immune response is the way the body protects itself against things it sees as harmful or foreign.

RNA (also called ribonucleic acid) is one of two types of nucleic acid made by cells. RNA contains information that has been copied from DNA (the other type of nucleic acid). Cells make several different forms of RNA, and each form has a specific job in the cell. Many forms of RNA have functions related to making proteins. RNA is also the genetic material of some viruses instead of DNA. RNA can be made in the laboratory and used in research studies. Also called ribonucleic acid.

Influenza is term used for flu illness. It is an infection caused by a virus that affects your mouth, nose, and throat.

The study is seeking for participants who:

  • are at least 18 years of age

  • have not received an influenza vaccine within the last 6 months

  • are generally healthy

This study will be divided into three sub-studies: Substudy A (SSA), Substudy B (SSB), and Substudy C (SSC).

All participants, regardless of sub-study, will receive 1 dose of either of the following vaccines as an injection into their arm:

  • 1 of the modRNA influenza vaccines that is being studied; or

  • an approved influenza vaccine approved for use in their respective age group.

Participants will be involved in this study for about 6 months. During this time, participants will have at least 3 clinic visits.

Eligibility Criteria

Inclusion

Key Inclusion Criteria

Applies to all 3 substudies:

  • participants ≥18 years of age.

  • generally healthy participants.

Substudy C ONLY:

  • receipt of licensed influenza vaccination for the 2023-2024 flu season at least 6 months ago.

Key Exclusion Criteria

All 3 substudies:

  • diagnosis of influenza (by clinical testing) in the last 6 months.

  • immunocompromised individuals with known or suspected immunodeficiency

  • receipt of any investigational or licensed influenza vaccines within 6 months.

Study Design

Total Participants: 1202
Treatment Group(s): 2
Primary Treatment: Quadrivalent Influenza Vaccine (QIV)
Phase: 2
Study Start date:
May 23, 2024
Estimated Completion Date:
February 03, 2025

Connect with a study center

  • Alliance for Multispecialty Research, LLC

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Headlands Research - Scottsdale

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Anaheim Clinical Trials, LLC

    Anaheim, California 92801
    United States

    Site Not Available

  • Orange County Research Center

    Lake Forest, California 92630
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    San Diego, California 92103
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Clinical Research Consulting

    Milford, Connecticut 06460
    United States

    Site Not Available

  • Indago Research & Health Center, Inc

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Research Centers of America

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Research Centers of America ( Hollywood )

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Palm Springs Community Health Center

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida 32801
    United States

    Site Not Available

  • Headlands Research Orlando

    Orlando, Florida 32819
    United States

    Site Not Available

  • Qps-Mra, Llc

    South Miami, Florida 33143
    United States

    Site Not Available

  • East-West Medical Research Institute

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • Prism Research LLC dba Nucleus Network

    Saint Paul, Minnesota 55114
    United States

    Site Not Available

  • Clinical Research Professionals

    Chesterfield, Missouri 63005
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Rochester Clinical Research, LLC

    Rochester, New York 14609
    United States

    Site Not Available

  • Duke Vaccine and Trials Unit

    Durham, North Carolina 27703
    United States

    Site Not Available

  • M3 Wake Research, Inc.

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Headlands Horizons LLC

    Brownsville, Texas 78526
    United States

    Site Not Available

  • SMS Clinical Research

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Clinical Trials of Texas, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Clinical Trials of Texas, LLC dba Flourish Research

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Dynamed Clinical Research, LP d/b/a DM Clinical Research

    Tomball, Texas 77375
    United States

    Site Not Available

  • J. Lewis Research, Inc. / Foothill Family Clinic

    Salt Lake City, Utah 84109
    United States

    Site Not Available

  • J. Lewis Research, Inc. / Foothill Family Clinic South

    Salt Lake City, Utah 84121
    United States

    Site Not Available

  • Charlottesville Medical Research

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Norfolk, Virginia 23502
    United States

    Site Not Available

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