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RECRUITING
NCT07272434
PHASE3

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

Sponsor: MAXVAX Biotechnology Limited Liability Company

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) in Adults Aged 60 Aears and Above

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25000

Start Date

2025-10-22

Completion Date

2028-12-31

Last Updated

2025-12-09

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell)

0.5 mL per dose

BIOLOGICAL

Placebo (Saline solution)

0.5 mL per dose

Locations (8)

Guangdong Provincial Center for Disease Control and Prevention

Guangzhou, Guangdong, China

Hebei Provincial Center for Disease Control and Prevention

Shijiazhuang, Hebei, China

Henan Center for Disease Control and Prevention

Zhengzhou, Henan, China

Hubei Provincial Center for Disease Control and Prevention

Wuhan, Hubei, China

Hunan Provincial Center for Disease Control and Prevention

Changsha, Hunan, China

Shaanxi Provincial Center for Disease Control and Prevention

Xi'an, Shaanxi, China

Shandong Province Centers for Disease Control and Prevention

Jinan, Shandong, China

Sichuan Center for Disease Control and Prevention

Chengdu, Sichuan, China