A Study About Modified RNA Vaccines Against Influenza in Healthy Adults

NCT ID: NCT06436703

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-23

Study Completion Date

2025-02-05

Brief Summary

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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.

Detailed Description

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Conditions

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Influenza, Human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
This study will be an observer-blinded and Sponsor-unblinded study.

Study Groups

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SSA: Influenza ModRNA Vaccine 2A

\- Single Dose on Day 1

Group Type EXPERIMENTAL

Influenza ModRNA Vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

SSA: Influenza ModRNA Vaccine 3A

\- Single Dose on Day 1

Group Type EXPERIMENTAL

Influenza ModRNA Vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

SSA: Influenza ModRNA Vaccine 4A

\- Single Dose on Day 1

Group Type EXPERIMENTAL

Influenza ModRNA Vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

SSA: Influenza ModRNA Vaccine 5A

\- Single dose on Day 1

Group Type EXPERIMENTAL

Influenza ModRNA Vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

SSA: QIV1

\- Single dose on Day 1

Group Type ACTIVE_COMPARATOR

Quadrivalent Influenza Vaccine (QIV)

Intervention Type BIOLOGICAL

Intramuscular injection

SSB: Influenza ModRNA Vaccine 3B

\- Single Dose on Day 1

Group Type EXPERIMENTAL

Influenza ModRNA Vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

SSB: Influenza ModRNA Vaccine 4B

\- Single Dose on Day 1

Group Type EXPERIMENTAL

Influenza ModRNA Vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

SSB: Influenza ModRNA Vaccine 5B

\- Single dose on Day 1

Group Type EXPERIMENTAL

Influenza ModRNA Vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

SSB: QIV2

\- Single Dose on Day 1

Group Type ACTIVE_COMPARATOR

Quadrivalent Influenza Vaccine (QIV)

Intervention Type BIOLOGICAL

Intramuscular injection

SSB: QIV3

\- Single Dose on Day 1

Group Type ACTIVE_COMPARATOR

Quadrivalent Influenza Vaccine (QIV)

Intervention Type BIOLOGICAL

Intramuscular injection

SSC: Influenza ModRNA Vaccine 3C

\- Single Dose on Day 1

Group Type EXPERIMENTAL

Influenza ModRNA Vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

SSC: Influenza ModRNA Vaccine 4C

\- Single Dose on Day 1

Group Type EXPERIMENTAL

Influenza ModRNA Vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

SSC: Influenza ModRNA Vaccine 5C

\- Single Dose on Day 1

Group Type EXPERIMENTAL

Influenza ModRNA Vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

SSC: Influenza ModRNA Vaccine 6C

\- Single Dose on Day 1

Group Type EXPERIMENTAL

Influenza ModRNA Vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

SSC: Influenza ModRNA Vaccine 7C

\- Single Dose on Day 1

Group Type EXPERIMENTAL

Influenza ModRNA Vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

SSC: Influenza ModRNA Vaccine 8C

\- Single Dose on Day 1

Group Type EXPERIMENTAL

Influenza ModRNA Vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

SSC: Influenza ModRNA Vaccine 9C

\- Single dose on Day 1

Group Type EXPERIMENTAL

Influenza ModRNA Vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

SSC: QIV2

\- Single Dose on Day 1

Group Type ACTIVE_COMPARATOR

Quadrivalent Influenza Vaccine (QIV)

Intervention Type BIOLOGICAL

Intramuscular injection

SSC: QIV3

\- Single Dose on Day 1

Group Type ACTIVE_COMPARATOR

Quadrivalent Influenza Vaccine (QIV)

Intervention Type BIOLOGICAL

Intramuscular injection

Interventions

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Influenza ModRNA Vaccine

Intramuscular injection

Intervention Type BIOLOGICAL

Quadrivalent Influenza Vaccine (QIV)

Intramuscular injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Alliance for Multispecialty Research, LLC

Mobile, Alabama, United States

Site Status

Headlands Research - Scottsdale

Scottsdale, Arizona, United States

Site Status

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Site Status

Orange County Research Center

Lake Forest, California, United States

Site Status

Artemis Institute for Clinical Research

San Diego, California, United States

Site Status

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

Clinical Research Consulting

Milford, Connecticut, United States

Site Status

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Site Status

Research Centers of America ( Hollywood )

Hollywood, Florida, United States

Site Status

Research Centers of America

Hollywood, Florida, United States

Site Status

Palm Springs Community Health Center

Miami Lakes, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Site Status

Headlands Research Orlando

Orlando, Florida, United States

Site Status

Qps-Mra, Llc

South Miami, Florida, United States

Site Status

East-West Medical Research Institute

Honolulu, Hawaii, United States

Site Status

Alliance for Multispecialty Research, LLC

New Orleans, Louisiana, United States

Site Status

Prism Research LLC dba Nucleus Network

Saint Paul, Minnesota, United States

Site Status

Clinical Research Professionals

Chesterfield, Missouri, United States

Site Status

Alliance for Multispecialty Research, LLC

Kansas City, Missouri, United States

Site Status

Rochester Clinical Research, LLC

Rochester, New York, United States

Site Status

Duke Vaccine and Trials Unit

Durham, North Carolina, United States

Site Status

M3 Wake Research, Inc.

Raleigh, North Carolina, United States

Site Status

DM Clinical Research - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Headlands Horizons LLC

Brownsville, Texas, United States

Site Status

SMS Clinical Research

Mesquite, Texas, United States

Site Status

Clinical Trials of Texas, LLC dba Flourish Research

San Antonio, Texas, United States

Site Status

Clinical Trials of Texas, LLC

San Antonio, Texas, United States

Site Status

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

Tomball, Texas, United States

Site Status

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, United States

Site Status

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

Salt Lake City, Utah, United States

Site Status

Charlottesville Medical Research

Charlottesville, Virginia, United States

Site Status

Alliance for Multispecialty Research, LLC

Norfolk, Virginia, United States

Site Status

Countries

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United States

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C4781013

To obtain contact information for a study center near you, click here.

Other Identifiers

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NCT06436703

Identifier Type: REGISTRY

Identifier Source: secondary_id

C4781013

Identifier Type: -

Identifier Source: org_study_id

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