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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT06583031•Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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

Eligibility

Age

60 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (6)

Site # 0361004

Botany, New South Wales, Australia

Site # 031001

Brookvale, New South Wales, Australia

Site # 0361006

Miranda, New South Wales, Australia

Site # 0361002

Wollongong, New South Wales, Australia

Site # 0361003

Herston, Queensland, Australia

Site # 0361005

South Brisbane, Queensland, Australia

Key Dates

Start Date

October 9, 2024

Primary Completion Date

October 9, 2025

Completion Date

October 9, 2025

Last Updated

November 20, 2025

Enrollment

385

ACTUAL participants

Conditions

RSV InfectionhMPV

Interventions

RSV/hMPV vaccine dose A1

BIOLOGICAL

RSV/hMPV vaccine dose A2

BIOLOGICAL

RSV/hMPV vaccine dose A3

BIOLOGICAL

RSV/hMPV vaccine dose B1

BIOLOGICAL

RSV/hMPV vaccine dose B2

BIOLOGICAL

RSV/hMPV vaccine dose B3

BIOLOGICAL

RSV/hMPV vaccine dose C1

BIOLOGICAL

RSV/hMPV vaccine dose C2

BIOLOGICAL

RSV/hMPV vaccine dose C3

BIOLOGICAL

RSV/hMPV vaccine dose 1

BIOLOGICAL

RSV/hMPV vaccine dose 2

BIOLOGICAL

RSV/hMPV vaccine dose 3

BIOLOGICAL

Monovalent RSV Vaccine

BIOLOGICAL

Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children

NCT03596801

RSV Infection

View study

COMPLETEDPHASE1

Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age

NCT04520659

RSV Infection

View study

TERMINATED

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: November 20, 2025Data 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 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

Inclusion Criteria

Exclusion Criteria

Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children

Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age

Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participants

A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.

Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit