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ACTIVE NOT RECRUITING
NCT07128121
PHASE2

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

Sponsor: Shenzhen Shenxin Biotechnology Co., Ltd

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2025-08-13

Completion Date

2029-10

Last Updated

2025-09-09

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006)

Formulation for injection

BIOLOGICAL

Placebo

0.9% sodium chloride (normal saline) injection

Locations (1)

Hunan Provincial Center for Disease Control and Prevention

Changsha, Hunan, China