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Active Not RecruitingNCT06645665

A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adult Aged 18 Years and Above

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) in Healthy Adult Aged 18 Years and Above

Status
Active Not Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
240 (estimated)
Sponsor
Shenzhen Shenxin Biotechnology Co., Ltd · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

The study will evaluate the safety, tolerability, and immunogenicity of 3 dose levels of IN006 in healthy adults aged 18 Years and Above; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults (aged ≥60 years).

Conditions

Interventions

TypeNameDescription
BIOLOGICALBivalent RSV Vaccine (IN006)Formulation for injection
BIOLOGICALPlacebo0.9% sodium chloride (normal saline) injection

Timeline

Start date
2024-11-11
Primary completion
2027-04-01
Completion
2027-04-01
First posted
2024-10-17
Last updated
2026-04-02

Locations

2 sites across 1 country: China

Source: ClinicalTrials.gov record NCT06645665. Inclusion in this directory is not an endorsement.