Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older

April 22, 2026 updated by: Sanofi Pasteur, a Sanofi Company

A Phase 1, Dose-Escalation, Randomized, Active-Controlled, Modified Double-Blind, Parallel-Group, Multi-Arm Study to Investigate the Safety and Immunogenicity of a Combined Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adult Participants Aged 60 Years and Older

The purpose of this phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The study will use different doses of PIV3 only and different combinations of RSV/hMPV/PIV3 or RSV/hMPV or only RSV vaccine in adults aged 60 years and older.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study duration will be up to approximately 12 months minus the screening period.

Study Type

Interventional

Enrollment (Actual)

390

Phase

  • 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 Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Investigational Site Number : 0360006
      • Botany, New South Wales, Australia, 2019
        • Investigational Site Number : 0360001
      • Brookvale, New South Wales, Australia, 2100
        • Investigational Site Number : 0360009
      • Kanwal, New South Wales, Australia, 2259
        • Investigational Site Number : 0360005
      • Miranda, New South Wales, Australia, 2228
        • Investigational Site Number : 0360004
    • Queensland
      • Herston, Queensland, Australia, 4006
        • Investigational Site Number : 0360008
    • Victoria
      • Bayswater, Victoria, Australia, 3153
        • Investigational Site Number : 0360003
      • Camberwell, Victoria, Australia, 3124
        • Investigational Site Number : 0360002

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 60 years or older on the day of inclusion (means from the means from the day of the 60th birthday).
  • Informed consent form (ICF) has been signed and dated
  • A female participant is eligible to participate if she is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.

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.

Note: 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
Intervention / Treatment
Experimental: PIV3 Dose 1
Participants will receive a single intramuscular (IM) injection at Day 1
Biological: parainfluenza virus type 3 vaccine (PIV3)
Pharmaceutical form:Frozen liquid solution -Route of administration:Intramuscular
Experimental: PIV3 Dose 2
Participants will receive a single intramuscular (IM) injection at Day 1
Biological: parainfluenza virus type 3 vaccine (PIV3)
Pharmaceutical form:Frozen liquid solution -Route of administration:Intramuscular
Experimental: PIV3 Dose 3
Participants will receive a single intramuscular (IM) injection at Day 1
Biological: parainfluenza virus type 3 vaccine (PIV3)
Pharmaceutical form:Frozen liquid solution -Route of administration:Intramuscular
Experimental: PIV3 Dose 4
Participants will receive a single intramuscular (IM) injection at Day 1
Biological: parainfluenza virus type 3 vaccine (PIV3)
Pharmaceutical form:Frozen liquid solution -Route of administration:Intramuscular
Experimental: RSV/hMPV /PIV3 Formulation 1
Participants will receive a single intramuscular (IM) injection at Day 1
Biological: RSV/hMPV/PIV3 vaccine
Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
Experimental: RSV/hMPV Formulation 1
Participants will receive a single intramuscular (IM) injection at Day 1
Biological: RSV/hMPV vaccine
Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
Experimental: RSV/hMPV Formulation 2
Participants will receive a single intramuscular (IM) injection at Day 1
Biological: RSV/hMPV vaccine
Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
Experimental: RSV vaccine 1
Participants will receive a single intramuscular (IM) injection at Day 1
Biological: RSV vaccine 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Experimental: RSV vaccine 2
Participants will receive a single intramuscular (IM) injection at Day 1
Biological: RSV vaccine 2
Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination
Time Frame: Within 30 minutes after each vaccination
Number of participants experiencing immediate unsolicited systemic AEs
Within 30 minutes after each vaccination
Presence of solicited administration site reactions within 7 days after vaccination
Time Frame: Within 7 days after vaccination

Number of participants reporting:

- injection site reactions: pain, erythema and swelling
Within 7 days after vaccination
Presence of solicited systemic reactions within 7 days after vaccination
Time Frame: Within 7 days after vaccination

Number of participants reporting:

  • systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills
Within 7 days after vaccination
Presence of unsolicited AEs within 28 days after vaccination
Time Frame: Within 28 days after vaccination
Number of participants experiencing unsolicited AEs
Within 28 days after vaccination
Presence of serious adverse events (SAEs)
Time Frame: Within 6 months after vaccination
Number of participants experiencing SAEs regardless of causality
Within 6 months after vaccination
Presence of adverse events of special interest (AESIs)
Time Frame: Within 6 months after vaccination
Number of participants experiencing AESIs regardless of causality
Within 6 months after vaccination
Presence of related SAEs throughout the study
Time Frame: Throughout the study, approximately 12 months
Number of participants experiencing related SAEs regardless of causality
Throughout the study, approximately 12 months
Presence of related AESIs throughout the study
Time Frame: Throughout the study, approximately 12 months
Number of participants experiencing related AESIs regardless of causality
Throughout the study, approximately 12 months
Presence of related fatal SAEs throughout the study
Time Frame: Throughout the study, approximately 12 months
Number of participants experiencing related fatal SAEs regardless of causality
Throughout the study, approximately 12 months
Presence of out-of-range biological test results (including shift from baseline values)
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RSV A serum neutralizing antibody (nAb) titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines
Time Frame: At Day 01 and Day 29
Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
At Day 01 and Day 29
RSV B serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines
Time Frame: At Day 01 and Day 29
Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
At Day 01 and Day 29
hMPV A serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 vaccines
Time Frame: At Day 01 and Day 29
Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
At Day 01 and Day 29
PIV3 serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV/PIV3 and PIV3 vaccines
Time Frame: At Day 01 and Day 29
Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
At Day 01 and Day 29

Collaborators and Investigators

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

Sponsor

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)

September 17, 2024

Primary Completion (Actual)

March 24, 2026

Study Completion (Actual)

March 24, 2026

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VBD00006
  • U1111-1304-9362 (Registry Identifier: WHO 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

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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