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OpenTrials
Completed

NCT Number: NCT06604767

Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults 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.

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Key information

Conditions

Respiratory Syncytial Virus Infection Infections Metapneumovirus Infection Mononegavirales Infections Parainfluenzae Virus Infection Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number : 0360006, Blacktown, New South Wales, Australia

Loading trial locations.

About this study

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

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 (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.

Treatment and study plan

parainfluenza virus type 3 vaccine (PIV3)

Biological

Pharmaceutical form:Frozen liquid solution -Route of administration:Intramuscular

RSV/hMPV/PIV3 vaccine

Biological

Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular

RSV/hMPV vaccine

Biological

Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular

RSV vaccine 1

Biological

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

RSV vaccine 2

Biological

Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Presence of unsolicited AEs within 28 days after vaccination

    Time frame: Within 28 days after vaccination

    Number of participants experiencing unsolicited AEs

  5. Presence of serious adverse events (SAEs)

    Time frame: Within 6 months after vaccination

    Number of participants experiencing SAEs regardless of causality

  6. Presence of adverse events of special interest (AESIs)

    Time frame: Within 6 months after vaccination

    Number of participants experiencing AESIs regardless of causality

  7. Presence of related SAEs throughout the study

    Time frame: Throughout the study, approximately 12 months

    Number of participants experiencing related SAEs regardless of causality

  8. Presence of related AESIs throughout the study

    Time frame: Throughout the study, approximately 12 months

    Number of participants experiencing related AESIs regardless of causality

  9. 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

  10. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Apr 23, 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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