A Study About Modified RNA Vaccines Against Influenza in Healthy Adults
A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINES AGAINST INFLUENZA IN HEALTHY ADULTS
2 other identifiers
interventional
1,202
1 country
32
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2024
Shorter than P25 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 23, 2024
CompletedFirst Submitted
Initial submission to the registry
May 24, 2024
CompletedFirst Posted
Study publicly available on registry
May 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2025
CompletedJanuary 9, 2026
January 1, 2026
9 months
May 24, 2024
January 7, 2026
Conditions
Outcome Measures
Primary Outcomes (18)
SSA - Percentage of Participants Reporting Local Reactions After Vaccination
Pain at the injection site, redness, and swelling.
From Day 1 Through at least Day 7 After Vaccination
SSA - Percentage of Participants Reporting Systemic Events After Vaccination
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.
From Day 1 Through at least Day 7 After Vaccination
SSA - Percentage of Participants Reporting Adverse Events After Vaccination
As elicited by investigational site staff
From Day 1 Through 4 Weeks After Vaccination
SSA - Percentage of Participants Reporting Serious Adverse Events (SAE)
As elicited by investigational site staff
From Day 1 Through 6 Months After Vaccination
SSA - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
As elicited by investigational site staff
From Day 1 Through 6 Months After Vaccination
SSA - Percentage of Participants Reporting Medically Attended AEs (MAEs)
As elicited by investigational site staff
From Day 1 Through 6 Months After Vaccination
SSB - Percentage of Participants Reporting Local Reactions After Vaccination
Pain at injection site, redness, and swelling.
From Day 1 Through at least Day 7 After Vaccination
SSB - Percentage of Participants Reporting Systemic Events After Vaccination
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.
From Day 1 Through at least Day 7 After Vaccination
SSB - Percentage of Participants Reporting Adverse Events After Vaccination
As elicited by investigational site staff
From Day 1 Through 4 Weeks After Vaccination
SSB - Percentage of Participants Reporting Serious Adverse Events (SAE)
As elicited by investigational site staff
From Day 1 Through 6 Months After Vaccination
SSB - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
As elicited by investigational site staff
From Day 1 Through 6 Months After Vaccination
SSB - Percentage of Participants Reporting Medically Attended AEs (MAEs)
As elicited by investigational site staff
From Day 1 Through 6 Months After Vaccination
SSC - Percentage of Participants Reporting Local Reactions After Vaccination
Pain at the injection site, redness, and swelling.
From Day 1 Through at least Day 7 After Vaccination
SSC - Percentage of Participants Reporting Systemic Events After Vaccination
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.
From Day 1 Through at least Day 7 After Vaccination
SSC - Percentage of Participants Reporting Adverse Events After Vaccination
As elicited by investigational site staff
From Day 1 Through 4 Weeks After Vaccination
SSC - Percentage of Participants Reporting Serious Adverse Events (SAE)
As elicited by investigational site staff
From Day 1 Through 6 Months After Vaccination
SSC - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
As elicited by investigational site staff
From Day 1 Through 6 Months After Vaccination
SSC - Percentage of Participants Reporting Medically Attended AEs (MAEs)
As elicited by investigational site staff
From Day 1 Through 6 Months After Vaccination
Secondary Outcomes (8)
SSA - HAI Geometric Mean Titers (GMTs) for each strain
4 Weeks After Vaccination
SSA - HAI geometric mean fold rise (GMFR) for each strain
4 Weeks After Vaccination
SSA - The proportion of participants achieving HAI seroconversion for each strain
4 Weeks After Vaccination
SSA - The proportion of participants with HAI titers ≥1:40 for each strain
Baseline and 4 Weeks After Vaccination
SSB - HAI geometric mean titers (GMTs) for each strain
4 Weeks After Vaccination
- +3 more secondary outcomes
Study Arms (19)
SSA: Influenza ModRNA Vaccine 2A
EXPERIMENTAL\- Single Dose on Day 1
SSA: Influenza ModRNA Vaccine 3A
EXPERIMENTAL\- Single Dose on Day 1
SSA: Influenza ModRNA Vaccine 4A
EXPERIMENTAL\- Single Dose on Day 1
SSA: Influenza ModRNA Vaccine 5A
EXPERIMENTAL\- Single dose on Day 1
SSA: QIV1
ACTIVE COMPARATOR\- Single dose on Day 1
SSB: Influenza ModRNA Vaccine 3B
EXPERIMENTAL\- Single Dose on Day 1
SSB: Influenza ModRNA Vaccine 4B
EXPERIMENTAL\- Single Dose on Day 1
SSB: Influenza ModRNA Vaccine 5B
EXPERIMENTAL\- Single dose on Day 1
SSB: QIV2
ACTIVE COMPARATOR\- Single Dose on Day 1
SSB: QIV3
ACTIVE COMPARATOR\- Single Dose on Day 1
SSC: Influenza ModRNA Vaccine 3C
EXPERIMENTAL\- Single Dose on Day 1
SSC: Influenza ModRNA Vaccine 4C
EXPERIMENTAL\- Single Dose on Day 1
SSC: Influenza ModRNA Vaccine 5C
EXPERIMENTAL\- Single Dose on Day 1
SSC: Influenza ModRNA Vaccine 6C
EXPERIMENTAL\- Single Dose on Day 1
SSC: Influenza ModRNA Vaccine 7C
EXPERIMENTAL\- Single Dose on Day 1
SSC: Influenza ModRNA Vaccine 8C
EXPERIMENTAL\- Single Dose on Day 1
SSC: Influenza ModRNA Vaccine 9C
EXPERIMENTAL\- Single dose on Day 1
SSC: QIV2
ACTIVE COMPARATOR\- Single Dose on Day 1
SSC: QIV3
ACTIVE COMPARATOR\- Single Dose on Day 1
Interventions
Intramuscular injection
Intramuscular injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (32)
Alliance for Multispecialty Research, LLC
Mobile, Alabama, 36608, United States
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Orange County Research Center
Lake Forest, California, 92630, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Clinical Research Consulting
Milford, Connecticut, 06460, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012, United States
Research Centers of America ( Hollywood )
Hollywood, Florida, 33024, United States
Research Centers of America
Hollywood, Florida, 33024, United States
Palm Springs Community Health Center
Miami Lakes, Florida, 33014, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Headlands Research Orlando
Orlando, Florida, 32819, United States
Qps-Mra, Llc
South Miami, Florida, 33143, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Alliance for Multispecialty Research, LLC
New Orleans, Louisiana, 70119, United States
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, 55114, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, 64114, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, 27703, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, 19107, United States
Headlands Horizons LLC
Brownsville, Texas, 78526, United States
SMS Clinical Research
Mesquite, Texas, 75149, United States
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas, 78229, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball, Texas, 77375, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Alliance for Multispecialty Research, LLC
Norfolk, Virginia, 23502, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- This study will be an observer-blinded and Sponsor-unblinded study.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2024
First Posted
May 31, 2024
Study Start
May 23, 2024
Primary Completion
February 5, 2025
Study Completion
February 5, 2025
Last Updated
January 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.