Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older

September 4, 2025 updated by: Sanofi Pasteur, a Sanofi Company

A Phase I, Dose-escalation, Parallel-group, Randomized, Multi-center Study to Assess Safety and Immunogenicity of an RSV/hMPV mRNA Vaccine Candidate in Healthy Participants Aged 18 to 49 Years and 60 Years and Older.

The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV) in older adults. A single intramuscular (IM) injection of 3 to 4 different doses of the RSV/hMPV mRNA vaccine candidate formulated with 2 different lipid nanoparticles (LNP) will be administered to healthy participants aged 18 to 49 years and 60 years and older.

Treatment:

  • RSV/hMPV mRNA / LNP 1 at 3-4 different doses or,
  • RSV/hMPV mRNA / LNP 2 at 3-4 difference doses or,
  • RSV mRNA / LNP 1 at 1 dose or,
  • hMPV mRNA / LNP 1 at 1 dose

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study duration per participant is approximately 6 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
558

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • Australia
      • Canberra, Australia, 2617
        • Investigational Site Number : 0360007
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Investigational Site Number : 0360006
      • Botany, New South Wales, Australia, 2019
        • Investigational Site Number : 0360002
      • Kanwal, New South Wales, Australia, 2259
        • Investigational Site Number : 0360003
      • Sydney, New South Wales, Australia, 2035
        • Investigational Site Number : 0360004
    • Queensland
      • Herston, Queensland, Australia, 4006
        • Investigational Site Number : 0360008
      • Morayfield, Queensland, Australia, 4506
        • Investigational Site Number : 0360005
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Investigational Site Number : 0360001
  • United States
    • California
      • Gardena, California, United States, 90247
        • Velocity Gardena Site Number : 8400011
    • Florida
      • Hallandale, Florida, United States, 33009
        • Velocity Clinical Research-Hallandale Beach- Site Number : 8400013
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research- Site Number : 8400005
    • Iowa
      • Sioux City, Iowa, United States, 51106
        • Velocity Clinical Research, Sioux City Site Number : 8400017
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Velocity Clinical Research- New Orleans Site Number : 8400016
    • New York
      • Binghamton, New York, United States, 13905
        • Meridian Clinical Research- Site Number : 8400007
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Velocity Clinical Research- Site Number : 8400012
    • South Carolina
      • North Charleston, South Carolina, United States, 29405
        • Coastal Carolina Research Center- Site Number : 8400001
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research Center Winding River - Site Number : 8400002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

-Informed consent form (ICF) has been signed and dated

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

-Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

--The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RSV/hMPV mRNA / LNP 1 Group 1
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 1.
Biological: RSV/hMPV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Experimental: RSV/hMPV mRNA / LNP 1 Group 2
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 2.
Biological: RSV/hMPV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Experimental: RSV/hMPV mRNA / LNP 1 Group 3
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 3.
Biological: RSV/hMPV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Experimental: RSV/hMPV mRNA / LNP 2 Group 4
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 2 dose 1.
Biological: RSV/hMPV mRNA LNP 2
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Experimental: RSV mRNA / LNP 1 Group 5
Participants will be randomized to receive a single IM injection of RSV mRNA / LNP vaccine 1 dose 1.
Biological: RSV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Experimental: hMPV mRNA / LNP 1 Group 6
Participants will be randomized to receive a single IM injection of hMPV mRNA / LNP vaccine 1 dose 1.
Biological: hMPV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Experimental: RSV/hMPV mRNA / LNP 1 Group 7
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 4.
Biological: RSV/hMPV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Presence of unsolicited AEs
Time Frame: Within 28 days after vaccination
Number of participants experiencing unsolicited AEs
Within 28 days after vaccination
Presence of out-of-range biological test results
Time Frame: Within 7 days after vaccination
Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)
Within 7 days after vaccination
Presence of unsolicited systemic immediate adverse events (AEs)
Time Frame: Within 30 minutes after vaccination
Number of participants experiencing immediate an immediate unsolicited systemic adverse event
Within 30 minutes after vaccination
Presence of solicited injection site or systemic reactions
Time Frame: Within 7 days after vaccination

Number of participants reporting:

  • injection site reactions: pain, erythema and swelling
  • systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills
Within 7 days after vaccination
Presence of medically attended adverse events (MAAEs)
Time Frame: Throughout study (up to approximately 6 months)
Number of participants experiencing MAAEs
Throughout study (up to approximately 6 months)
Presence of serious adverse events (SAEs)
Time Frame: Throughout study (up to approximately 6 months)
Throughout study (up to approximately 6 months)
Throughout study (up to approximately 6 months)
Presence of adverse events of special interest (AESIs)
Time Frame: Throughout study (up to approximately 6 months)
Number of participants experiencing AESIs
Throughout study (up to approximately 6 months)
RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations
Time Frame: Day 1 and Day 29
RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
Day 1 and Day 29
RSV-B serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations
Time Frame: Day 1 and Day 29
RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
Day 1 and Day 29
hMPV- A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent hMPV formulations
Time Frame: Day 1 and Day 29
hMPV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
Day 1 and Day 29

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
RSV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation
Time Frame: Day 1, Day 29, Day 91 and Day 181
RSV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination
Day 1, Day 29, Day 91 and Day 181
RSV B serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation
Time Frame: Day 1, Day 29, Day 91 and Day 181
RSV B serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination
Day 1, Day 29, Day 91 and Day 181
RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation
Time Frame: Day 1, Day 29, Day 91 and Day 181
RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination
Day 1, Day 29, Day 91 and Day 181
hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations
Time Frame: Day 1, Day 29, Day 91 and Day 181
hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination
Day 1, Day 29, Day 91 and Day 181
hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations
Time Frame: Day 1, Day 29, Day 91 and Day 181
hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination
Day 1, Day 29, Day 91 and Day 181

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VAV00027 (Other Identifier: Sanofi Identifier)
  • U1111-1295-2931 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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