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Study on Efficacy of Attenuated Zoster Vaccine, Live

NCT04334577 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25000

Last updated 2021-12-08

No results posted yet for this study

Summary

Varicella-zoster virus (VZV) is a herpesvirus that causes two distinct clinical syndromes. Primary infection is manifested as varicella (chickenpox) , whereas reactivation of latent VZV results in a localized eruption known as herpes zoster. The investigational vaccine of this study is produced by Changchun BCHT biotechnology Co. It's a live attenuated herpes zoster vaccine based on the production process of live attenuated chickenpox vaccine.This study plans to have 25000 adults aged 40 years or older and involves in a randomized, double-blind, placebo-controlled trial . The primary outcome is to evaluate the efficacy of the vaccine against herpes zoster 30 days after vaccination and the safety of the vaccine.

Conditions

  • Herpes Zoster

Interventions

BIOLOGICAL

live attenuated zoster vaccine

subcutaneous injection

BIOLOGICAL

placebo

subcutaneous injection

Sponsors & Collaborators

  • Changchun BCHT Biotechnology Co.

    lead INDUSTRY

Principal Investigators

  • Fengcai Zhu, Master · LocationJiangsu Province Center for Disease Control and Prevention

  • Zhiping Chen · Zhejiang Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-20
Primary Completion
2021-07-18
Completion
2021-07-18

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT04334577 on ClinicalTrials.gov