Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate
NCT06134648 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 646
Last updated 2026-03-12
Summary
The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of different doses of an respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine candidate, in adult participants aged 60 years and older. In addition, the study will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population.
Conditions
- Respiratory Syncytial Virus Infection
- Healthy Volunteers
- Human Metapneumovirus
Interventions
- BIOLOGICAL
-
RSV/hMPV vaccine candidate Dose L
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
- BIOLOGICAL
-
RSV/hMPV vaccine candidate Dose A
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
- BIOLOGICAL
-
RSV/hMPV vaccine candidate Dose B
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
- BIOLOGICAL
-
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Sponsors & Collaborators
-
Sanofi Pasteur, a Sanofi Company
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-11-01
- Primary Completion
- 2026-02-27
- Completion
- 2026-02-27
- FDA Drug
- Yes
Countries
- United States
- Puerto Rico
Study Locations
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