Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years

November 19, 2025 updated by: Sanofi Pasteur, a Sanofi Company

A Phase 1, Randomized, Modified Double-blind, Multi-center, Parallel Group, Multi-arm Study to Investigate the Safety and Immunogenicity of an RSV/hMPV Vaccine Candidate in Adult Participants Aged 60 to 75 Years

VAV00039 is a first-in-human (FiH) study to assess the safety and immunogenicity (in adult participants aged 60-75 years) after a single injection of different dose formulations of an RSV/hMPV vaccine candidate and RSV vaccine.

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

The duration of participation will be approximately 6 months for each participant.

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.
385

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: Sanofi Trial Transparency Email Recommended (Toll free for US and Canada
  • Phone Number: Opt. 6 800-633-1610
  • Email: contact-us@saonofi.com

Study Locations

  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Site # 0361004
      • Brookvale, New South Wales, Australia, 2100
        • Site # 031001
      • Miranda, New South Wales, Australia, 2228
        • Site # 0361006
      • Wollongong, New South Wales, Australia, 2500
        • Site # 0361002
    • Queensland
      • Herston, Queensland, Australia, 4006
        • Site # 0361003
      • South Brisbane, Queensland, Australia, 4101
        • Site # 0361005

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:

  • Aged 60 to 75 years on the day of inclusion
  • A female participant is eligible to participate if she is post-menopausal for at least 1 year, or surgically sterile

Exclusion Criteria:

  • 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: Group 1 RSV/hMPV dose A1
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose A1
Suspension for injection. Route of administration: IM injection
Experimental: Group 2 RSV/hMPV dose A2
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose A2
Suspension for injection. Route of administration: IM injection
Experimental: Group 3 RSV/hMPV dose A3
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose A3
Suspension for injection. Route of administration: IM injection
Experimental: Group 4 RSV/hMPV dose B1
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose B1
Suspension for injection. Route of administration: IM injection
Experimental: Group 5 RSV/hMPV dose B2
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose B2
Suspension for injection. Route of administration: IM injection
Experimental: Group 6 RSV/hMPV dose B3
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose B3
Suspension for injection. Route of administration: IM injection
Experimental: Group 7 RSV/hMPV dose C1
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose C1
Suspension for injection. Route of administration: IM injection
Experimental: Group 8 RSV/hMPV dose C2
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose C2
Suspension for injection. Route of administration: IM injection
Experimental: Group 9 RSV/hMPV dose C3
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose C3
Suspension for injection. Route of administration: IM injection
Experimental: Group 10 RSV/hMPV dose 1
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose 1
Suspension for injection. Route of administration: IM injection
Experimental: Group 11 RSV/hMPV dose 2
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose 2
Suspension for injection. Route of administration: IM injection
Experimental: Group 12 RSV/hMPV dose 3
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose 3
Suspension for injection. Route of administration: IM injection
Experimental: Group 13 Monovalent RSV Vaccine
Participants will receive a single IM injection on day 1 of a Monovalent (MV) RSV vaccine according to their randomization schedule.
Biological: Monovalent RSV Vaccine
Suspension for injection. Route of administration: IM 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
Time Frame
Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
Time Frame: On Day 1
On Day 1
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination
Time Frame: Day 1 through day 8
Day 1 through day 8
Presence of unsolicited AEs reported through 28 days after vaccination
Time Frame: Day 1 through day 29
Day 1 through day 29
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study (ie, through 6 months after vaccination
Time Frame: SAE: Screening through day 181; AESI: Day 1 through day 181
SAE: Screening through day 181; AESI: Day 1 through day 181
Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination
Time Frame: Screening through day 8
Screening through day 8

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
Time Frame
RSV A and RSV B serum nAb (neutralizing antibodies) titers at pre-vaccination and 28 days post-vaccination in all participants
Time Frame: At day 1 and day 29
At day 1 and day 29
hMPV A serum nAb titers at pre-vaccination and 28 days post-vaccination in all participants, except in those receiving the MV RSV vaccine
Time Frame: At day 1 and day 28
At day 1 and day 28
RSV A and RSV B nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants
Time Frame: At day 1, day 29, day 91, and day 181
At day 1, day 29, day 91, and day 181
RSV A serum anti-F IgG (immunoglobulin type G) Ab (Antibody) titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants
Time Frame: At day 1, day 29, day 91, and day 181
At day 1, day 29, day 91, and day 181
hMPV A nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants, except in those receiving the MV RSV vaccine
Time Frame: At day 1, day 29, day 91, and day 181
At day 1, day 29, day 91, and day 181
hMPV serum anti-F IgG Ab titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants, except in those receiving the MV RSV vaccine
Time Frame: At day 1, day 29, day 91, and day 181
At 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.
October 9, 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.
October 9, 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.
October 9, 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).
August 30, 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.
August 30, 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.
September 3, 2024

Study Record Updates

Last Update Posted (Actual)

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.
November 20, 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.
November 19, 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.
October 1, 2025

More Information

Terms related to this study

Keywords

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.
  • VAV00039
  • U1111-1308-3615 (Other Identifier: WHO UTN)

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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