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Efficacy, Safety and Immunogenicity Study of Recombinant Zoster Vaccine(CHO Cell) in Adults Aged 40 Years and Older

NCT06447779 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25000

Last updated 2024-10-24

No results posted yet for this study

Summary

The purpose of the sutdy is to evaluate efficacy, safety and immunogenicity of Recombinant Zoster Vaccine (CHO Cell) with 2 doses at 2-month interval in adults aged 40 years and older.

Conditions

  • Herpes Zoster

Interventions

BIOLOGICAL

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

BIOLOGICAL

NaCl solution Placebo

0.5 mL per dose, containing 4.5 mg sodium chloride. Intramuscular injection

Sponsors & Collaborators

  • MAXVAX Biotechnology Limited Liability Company

    lead INDUSTRY

Principal Investigators

  • Wang Yanxia · Henan Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-13
Primary Completion
2025-09-30
Completion
2027-09-30

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 NCT06447779 on ClinicalTrials.gov