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
NCT06583031 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 385
Last updated 2025-11-20
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.
Conditions
- RSV Infection
- hMPV
Interventions
- 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
- BIOLOGICAL
-
RSV/hMPV vaccine dose 1
Suspension for injection. Route of administration: IM injection
- 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
Sponsors & Collaborators
-
Sanofi Pasteur, a Sanofi Company
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-10-09
- Primary Completion
- 2025-10-09
- Completion
- 2025-10-09
Countries
- Australia
Study Locations
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