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A Study About Modified RNA Vaccines Against Influenza in Healthy Adults
Sponsor: Pfizer
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.
Official title: A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINES AGAINST INFLUENZA IN HEALTHY ADULTS
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1202
Start Date
2024-05-23
Completion Date
2025-02-05
Last Updated
2026-06-12
Healthy Volunteers
Yes
Conditions
Interventions
Influenza ModRNA Vaccine
Intramuscular injection
Quadrivalent Influenza Vaccine (QIV)
Intramuscular injection
Locations (32)
AMR Clinical
Mobile, Alabama, United States
Headlands Research - Scottsdale
Scottsdale, Arizona, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Orange County Research Center
Lake Forest, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Clinical Research Consulting
Milford, Connecticut, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Research Centers of America ( Hollywood )
Hollywood, Florida, United States
Research Centers of America
Hollywood, Florida, United States
Palm Springs Community Health Center
Miami Lakes, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Headlands Research Orlando
Orlando, Florida, United States
Qps-Mra, Llc
South Miami, Florida, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Alliance for Multispecialty Research, LLC
New Orleans, Louisiana, United States
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, United States
Headlands Horizons LLC
Brownsville, Texas, United States
SMS Clinical Research
Mesquite, Texas, United States
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
AMR Clinical
Norfolk, Virginia, United States