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_1
Started May 2024
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
CompletedResults Posted
Study results publicly available
June 12, 2026
CompletedJune 12, 2026
June 1, 2026
9 months
May 24, 2024
January 15, 2026
June 9, 2026
Conditions
Outcome Measures
Primary Outcomes (18)
SSA: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination. All local reactions were graded based on center for biologics evaluation and research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSB: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSC: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSA: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSB: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSC: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSA: Percentage of Participants With Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From study vaccination on Day 1 through 4 weeks after study vaccination
SSB: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From study vaccination on Day 1 through 4 weeks after study vaccination
SSC: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From study vaccination on Day 1 through 4 weeks after study vaccination
SSA: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
From study vaccination on Day 1 through 6 months after study vaccination
SSB: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
From study vaccination on Day 1 through 6 months after study vaccination
SSC: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
From study vaccination on Day 1 through 6 months after study vaccination
SSA: Percentage of Participants With Medically Attended Adverse Events (MAEs) From Vaccination Through 6 Months After Vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
From study vaccination on Day 1 through 6 months after study vaccination
SSB: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
From study vaccination on Day 1 through 6 months after study vaccination
SSC: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
From study vaccination on Day 1 through 6 months after study vaccination
SSA: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination Through 6 Months After Vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
From study vaccination on Day 1 through 6 months after study vaccination
SSB: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
From study vaccination on Day 1 through 6 months after study vaccination
SSC: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
From study vaccination on Day 1 through 6 months after study vaccination
Secondary Outcomes (8)
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
SSA: Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
From before study vaccination on Day 1 up to 4 weeks after study vaccination
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
4 weeks after study vaccination
SSA: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
SSB: GMTs of Strain-Specific HAI Titers at Baseline and 4 Weeks After Vaccination
Baseline (before study vaccination on Day 1), 4 weeks after study 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)
AMR Clinical
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
AMR Clinical
Norfolk, Virginia, 23502, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
As per Sponsor's decision information on formulation and dose has not been disclosed in the results summary to maintain the company confidentiality.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- 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
June 12, 2026
Results First Posted
June 12, 2026
Record last verified: 2026-06
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.