NCT07128121

A Phase 2 Study to Describe the Safety and Immunogenicity of Respiratory Syncytial Virus Vaccine IN006 in Healthy Participants Aged 60 Years and Older

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Immunogenicity of the Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) in Healthy Participants Aged 60 Years and Older

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Shenzhen Shenxin Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
BIOLOGICAL	Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006)	Formulation for injection
BIOLOGICAL	Placebo	0.9% sodium chloride (normal saline) injection

Timeline

• Start date: 2025-08-13
• Primary completion: 2029-10-01
• Completion: 2029-10-01
• First posted: 2025-08-17
• Last updated: 2025-09-09

Locations

1 site across 1 country: China