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ACTIVE NOT RECRUITING
NCT06645665
PHASE1

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

Sponsor: Shenzhen Shenxin Biotechnology Co., Ltd

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2024-11-11

Completion Date

2027-04

Last Updated

2026-04-02

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Bivalent RSV Vaccine (IN006)

Formulation for injection

BIOLOGICAL

Placebo

0.9% sodium chloride (normal saline) injection

Locations (2)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Anning First People's Hospital

Kunming, Yunnan, China