A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adults
NCT06287450 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2026-04-13
Summary
The study will evaluate the safety, tolerability, and immunogenicity of a single injection of up to 4 dose levels of IN006 in younger adults and 3 dose levels of IN006 in older adults; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults.
Conditions
- Respiratory Syncytial Virus Infections
Interventions
- BIOLOGICAL
-
Bivalent RSV 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
- 18 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-12-31
- Primary Completion
- 2028-04-30
- Completion
- 2028-04-30
- FDA Drug
- Yes
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