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Completed

NCT Number: NCT06583031

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

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.

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Key information

Conditions

RSV Infection Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases hMPV

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site # 0361004, Botany, New South Wales, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

RSV/hMPV vaccine dose A1

Biological

Suspension for injection. Route of administration: IM injection

RSV/hMPV vaccine dose A2

Biological

Suspension for injection. Route of administration: IM injection

RSV/hMPV vaccine dose A3

Biological

Suspension for injection. Route of administration: IM injection

RSV/hMPV vaccine dose B1

Biological

Suspension for injection. Route of administration: IM injection

RSV/hMPV vaccine dose B2

Biological

Suspension for injection. Route of administration: IM injection

RSV/hMPV vaccine dose B3

Biological

Suspension for injection. Route of administration: IM injection

RSV/hMPV vaccine dose C1

Biological

Suspension for injection. Route of administration: IM injection

RSV/hMPV vaccine dose C2

Biological

Suspension for injection. Route of administration: IM injection

RSV/hMPV vaccine dose C3

Biological

Suspension for injection. Route of administration: IM injection

RSV/hMPV vaccine dose 1

Biological

Suspension for injection. Route of administration: IM injection

RSV/hMPV vaccine dose 2

Biological

Suspension for injection. Route of administration: IM injection

RSV/hMPV vaccine dose 3

Biological

Suspension for injection. Route of administration: IM injection

Monovalent RSV Vaccine

Biological

Suspension for injection. Route of administration: IM injection

Primary outcomes

  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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2024
Registry last updated
Nov 20, 2025

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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