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Active Not RecruitingNCT07293065

A Phase III Clinical Trial to Evaluate Long-Term Protective Efficacy of Recombinant Zoster Vaccine (CHO Cell)

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

Status
Active Not Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
12,000 (estimated)
Sponsor
MAXVAX Biotechnology Limited Liability Company · Industry
Sex
All
Age
40 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALRecombinant 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
BIOLOGICALNaCl solution Placebo0.5 mL per dose, containing 4.5 mg sodium chloride. Intramuscular injection

Timeline

Start date
2025-12-15
Primary completion
2027-12-31
Completion
2028-12-31
First posted
2025-12-18
Last updated
2026-03-10

Locations

4 sites across 1 country: China

Source: ClinicalTrials.gov record NCT07293065. Inclusion in this directory is not an endorsement.