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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 385 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• RSV Infection
• hMPV

Interventions

Type	Name	Description
BIOLOGICAL	RSV/hMPV vaccine dose A1	Suspension for injection. Route of administration: IM injection
BIOLOGICAL	RSV/hMPV vaccine dose A2	Suspension for injection. Route of administration: IM injection
BIOLOGICAL	RSV/hMPV vaccine dose A3	Suspension for injection. Route of administration: IM injection
BIOLOGICAL	RSV/hMPV vaccine dose B1	Suspension for injection. Route of administration: IM injection
BIOLOGICAL	RSV/hMPV vaccine dose B2	Suspension for injection. Route of administration: IM injection
BIOLOGICAL	RSV/hMPV vaccine dose B3	Suspension for injection. Route of administration: IM injection
BIOLOGICAL	RSV/hMPV vaccine dose C1	Suspension for injection. Route of administration: IM injection
BIOLOGICAL	RSV/hMPV vaccine dose C2	Suspension for injection. Route of administration: IM injection
BIOLOGICAL	RSV/hMPV vaccine dose C3	Suspension for injection. Route of administration: IM injection
BIOLOGICAL	RSV/hMPV vaccine dose 1	Suspension for injection. Route of administration: IM injection
BIOLOGICAL	RSV/hMPV vaccine dose 2	Suspension for injection. Route of administration: IM injection
BIOLOGICAL	RSV/hMPV vaccine dose 3	Suspension for injection. Route of administration: IM injection
BIOLOGICAL	Monovalent RSV Vaccine	Suspension for injection. Route of administration: IM injection

Timeline

• Start date: 2024-10-09
• Primary completion: 2025-10-09
• Completion: 2025-10-09
• First posted: 2024-09-03
• Last updated: 2025-11-20

Locations

6 sites across 1 country: Australia