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

NCT07128121 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-09-09

No results posted yet for this study

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

BIOLOGICAL

Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006)

Formulation for injection

BIOLOGICAL

Placebo

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
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-13
Primary Completion
2029-10-31
Completion
2029-10-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07128121 on ClinicalTrials.gov