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NCT Number: NCT07810010

Phase 2b Study of a Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Protein Vaccine Candidate in Adults 60 Years of Age and Older

Study VCA25397 is a Phase 2b, observer-blind, randomized, placebo-controlled, parallel, case-driven proof of concept study that will enroll approximately 8000 adults aged 60 years and older to assess the clinical efficacy, safety, and immunogenicity of a single IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate.

The study will include a Safety Lead-in Cohort that will be enrolled first and will comprise 200 participants aged 60 years and older randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo (100 participants per arm).

The enrollment of the Main Cohort will start after the completion of the ESDR (Early Safety Data Review), pending a positive outcome. For the Main Cohort, 7800 participants (3900 participants per arm) will be randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo.

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Key information

Conditions

Respiratory Syncytial Virus Healthy Volunteers Human Metapneumovirus

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 60 years or older on the day of inclusion
  • Participants who, as determined by medical evaluation including medical history, physical examination, and clinical judgment of the Investigator are eligible for inclusion

Exclusion criteria

  • Known/suspected immunodeficiency; immunosuppressive therapy/immunomodulators in past 6 months; long-term systemic corticosteroids (eg, prednisone for more than 2 weeks in past 3 months); history of immune-mediated neurological disease. Of note, persons living with stable HIV are not excluded
  • Known systemic hypersensitivity to any of the study intervention components or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
  • Previous history of Guillain-Barré Syndrome (GBS)
  • Previous vaccination against RSV and/or HMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens) or previous receipt of RSV and/or HMPV monoclonal antibody

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

Treatment and study plan

Bivalent RSV+HMPV protein vaccine

Biological

IM injection

Other names: RPF08203

Placebo

Biological

IM injection

Primary outcomes

  1. Occurrence of the first episode of RSV-LRTD (Lower Respiratory Tract Disease)

    Time frame: From 14 days to 12 months after vaccination

  2. Occurrence of the first episode of HMPV-LRTD

    Time frame: From 14 days to 12 months after vaccination

Secondary outcomes

  1. Occurrence of the first episode of RSV-LRTD and/or HMPV-LRTD

    Time frame: From 14 days to 12 months after vaccination

  2. Occurrence of the first episode of RSV-ARD (Acute Respiratory Disease) and/or HMPV-ARD

    Time frame: From 14 days to 12 months after vaccination

  3. Occurrence of the first episode of severe RSV-LRTD and/or severe HMPV-LRTD

    Time frame: From 14 days to 12 months after vaccination

  4. Occurrence of the first episode of RSV-URTD and/or HMPV-URTD

    Time frame: From 14 days to 12 months after vaccination

  5. RSV A, RSV B, and HMPV A, HMPV B serum nAb titers in a subset of participants

    Time frame: At pre-vaccination and 8 days, 28 days, 6 months and 12 months post- vaccination

  6. Presence of immediate unsolicited systemic AEs (Adverse Events)

    Time frame: Within 30 minutes after vaccination

  7. Presence of solicited injection site and systemic reactions in a subset of participants

    Time frame: Up to 7 days after vaccination

  8. Presence of unsolicited AEs reported

    Time frame: Up to 27 days after vaccination

  9. Presence of MAAEs (Medically Attended Adverse Events)

    Time frame: Within 6 months after vaccination

  10. Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Event of Special Interest)

    Time frame: Within 6 months after vaccination

  11. Presence of related SAEs, related AESIs, and fatal SAEs

    Time frame: Up to 12 months post-vaccination

  12. Presence of out-of-range biological test results in a subset of participants

    Time frame: 7 days after vaccination

Study contacts

Contact information is provided by the study sponsor or research team.

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Phase 2b, Randomized, Placebo-controlled, Observer-blind Study in Adults 60 Years of Age and Older to Evaluate the Efficacy, Safety, and Immunogenicity of a Bivalent Protein Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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