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Phase III Clinical Trial of the Recombinant Respiratory Syncytial Virus Vaccine ( CHO Cell)

NCT07272434 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25000

Last updated 2025-12-09

No results posted yet for this study

Summary

This study will evaluate the efficacy of the Recombinant RSV vaccine(CHO cell) vaccine in preventing lower respiratory tract diseases(LRTD) caused by RSV in adults≥ 60 years of following a single dose of the RSV vaccine(CHO cell) vaccine .This study will also assess if the vaccine is safe and induces an immune response.

Conditions

  • Respiratory Syncytial Virus (RSV)

Interventions

BIOLOGICAL

Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell)

0.5 mL per dose

BIOLOGICAL

Placebo (Saline solution)

0.5 mL per dose

Sponsors & Collaborators

  • Henan Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Hunan Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Hubei Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Shaanxi Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Guangdong Center for Disease Prevention and Control

    collaborator OTHER_GOV

  • Shandong Province Centers for Disease Control and Prevention

    collaborator OTHER

  • Sichuan Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Hebei CDC ,China

    collaborator UNKNOWN

  • MAXVAX Biotechnology Limited Liability Company

    lead INDUSTRY

Principal Investigators

  • Yanxia Wang · Henan Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-22
Primary Completion
2026-07-31
Completion
2028-12-31

Countries

  • China

Study Locations

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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 NCT07272434 on ClinicalTrials.gov