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

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT06583031

Acronym / sponsor ID

VAV00039

Conditions

RSV Infection, hMPV

Keywords

RSV, RSV Infection, RSV Vaccine, hMPV, hMPV Infection, hMPV Vaccine

Phase

Phase 1

Study type

Interventional

Recruitment status

Completed

Enrolment

385 participants (actual)

Lead sponsor

Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)

Study start

9 Oct 2024 (actual)

Primary completion

9 Oct 2025 (actual)

Study completion

9 Oct 2025 (actual)

First posted

3 Sep 2024 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Parallel groups

Masking

Triple blind (participant, care provider, investigator)

Number of arms

13

Who may qualify

Ages

60 to 75 years

Sex

All

Healthy volunteers

Accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination

   Time frame: On Day 1

2. 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

3. Presence of unsolicited AEs reported through 28 days after vaccination

   Time frame: Day 1 through day 29

4. 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

5. Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination

   Time frame: Screening through day 8

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
• Plain Language Results SummaryLink provided by the sponsor.
• Individual participant dataSharing planned: Yes. 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.