A Phase 2 Study to Describe the Safety and Immunogenicity of Respiratory Syncytial Virus Vaccine IN006 in Healthy Participants Aged 60 Years and Older
NCT07128121 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2025-09-09
Summary
The study will evaluate the safety, tolerability, and immunogenicity of 2 dose levels of IN006 in healthy participants who aged at 60 years or older; of a revaccination of IN006 given 12 months or 24 months after the initial vaccination.
Conditions
- Respiratory Syncytial Virus (RSV) Infection
Interventions
- BIOLOGICAL
-
Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006)
Formulation for injection
- BIOLOGICAL
-
0.9% sodium chloride (normal saline) injection
Sponsors & Collaborators
-
Shenzhen Shenxin Biotechnology Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-08-13
- Primary Completion
- 2029-10-31
- Completion
- 2029-10-31
Countries
- China
Study Locations
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