A Phase III Clinical Trial to Evaluate Long-Term Protective Efficacy of Recombinant Zoster Vaccine (CHO Cell)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- The person-year incidence of confirmed herpes zoster cases among individuals aged 40 years and older, 13 to 36 months after completing the full vaccination course with the investigational vaccine according to the 0- and 2-month immunization schedule. — At 13~36 months after the last vaccination
A suspected case of HZ was confirmed either: by Polymerase Chain Reaction (PCR) or by the Endpoint Adjudication Committee (EAC), consisting of physicians with HZ expertise.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Hebei Provincial Center for Disease Control and Prevention | Shijiazhuang | Hebei | |
| Henan Center for Diseases Control and Prevention | Zhengzhou | Henan | |
| Hubei Provincial Center for Disease Control and Prevention | Wuhan | Hubei | |
| Yunnan Center For Disease Control and Prevention | Kunming | Yunnan |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07293065 on ClinicalTrials.gov ↗ ← All trials in China