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A Phase III Clinical Trial to Evaluate Long-Term Protective Efficacy of Recombinant Zoster Vaccine (CHO Cell)
Sponsor: MAXVAX Biotechnology Limited Liability Company
Summary
The purpose of the sutdy is to evaluate the protective efficacy of Recombinant Herpes Zoster Vaccine (CHO Cell) (hereinafter referred to as "the investigational vaccine") in preventing herpes zoster at 13-36 months after complete immunization with the 0- and 2-month immunization schedule in individuals aged 40 years and older.
Official title: A Multicenter, Double-Blind, Placebo-Controlled Phase III Clinical Trial to Evaluate the Long-Term Protective Efficacy of Recombinant Herpes Zoster Vaccine (CHO Cell) in Adults Aged 40 Years and Above
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
12000
Start Date
2025-12-15
Completion Date
2028-12-31
Last Updated
2026-03-10
Healthy Volunteers
Yes
Conditions
Interventions
Recombinant Zoster Vaccine (CHO Cell)
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with MA105. Intramuscular injection
NaCl solution Placebo
0.5 mL per dose, containing 4.5 mg sodium chloride. Intramuscular injection
Locations (4)
Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, China
Henan Center for Diseases Control and Prevention
Zhengzhou, Henan, China
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China
Yunnan Center For Disease Control and Prevention
Kunming, Yunnan, China