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

ACTIVE_NOT_RECRUITINGPHASE1

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

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

NCT06604767•Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (8)

Investigational Site Number : 0360006

Blacktown, New South Wales, Australia

Investigational Site Number : 0360001

Botany, New South Wales, Australia

Investigational Site Number : 0360009

Brookvale, New South Wales, Australia

Investigational Site Number : 0360005

Kanwal, New South Wales, Australia

Investigational Site Number : 0360004

Miranda, New South Wales, Australia

Investigational Site Number : 0360008

Herston, Queensland, Australia

Investigational Site Number : 0360003

Bayswater, Victoria, Australia

Investigational Site Number : 0360002

Camberwell, Victoria, Australia

Key Dates

Start Date

September 17, 2024

Primary Completion Date

March 25, 2026

Completion Date

March 25, 2026

Last Updated

January 22, 2026

Enrollment

390

ACTUAL participants

Conditions

Respiratory Syncytial Virus InfectionMetapneumovirus InfectionParainfluenzae Virus Infection

Interventions

parainfluenza virus type 3 vaccine (PIV3)

BIOLOGICAL

RSV/hMPV/PIV3 vaccine

BIOLOGICAL

RSV/hMPV vaccine

BIOLOGICAL

RSV vaccine 1

BIOLOGICAL

RSV vaccine 2

BIOLOGICAL

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

NCT07220109

Respiratory Syncytial Virus Infections

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RECRUITINGPHASE2

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

NCT07092865

Respiratory Syncytial Virus Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

Genotype and Disease Burden of RSV in Older Vietnamese Adults (RSV: Respiratory Syncytial Virus )

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children

Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)