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Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age

NCT03314103 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30000

Last updated 2021-03-30

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. More than 99.6% of people 40 years of age orolder had evidence of previous VZV infection. This study plans to have 30000 adults 40 years of age or older involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated varicella-zoster virus vaccine. The investigational vaccines are produced by Changchun Changsheng biotechnology co. LTD. The incidence of herpes zoster and the severity, and duration of the associated pain and discomfort were measured after the vaccination. And the safety of the varicella-zoster virus vaccine is also evaluated.

Conditions

  • Herpes Zoster

Interventions

BIOLOGICAL

One shot of the varicella-zoster virus vaccine

One shot of the live attenuated varicella-zoster virus vaccine (with live virus \>=4.3 LgPFU per dose)

BIOLOGICAL

one shot of placebo

one shot of placebo with no live virus

Sponsors & Collaborators

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-06
Primary Completion
2019-01-19
Completion
2019-01-19

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 NCT03314103 on ClinicalTrials.gov