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ACTIVE NOT RECRUITING
NCT06604767
PHASE1

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

Sponsor: 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.

Official 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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

390

Start Date

2024-09-17

Completion Date

2026-03-25

Last Updated

2026-01-22

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

parainfluenza virus type 3 vaccine (PIV3)

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

BIOLOGICAL

RSV/hMPV/PIV3 vaccine

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

BIOLOGICAL

RSV/hMPV vaccine

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

BIOLOGICAL

RSV vaccine 1

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

BIOLOGICAL

RSV vaccine 2

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

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