NCT03314103

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

A Multi-center, Randomized, Double-blinded, Phase 3 Trial to Evaluate the Efficacy Against Herpes Zoster of a Live Attenuated Varicella-Zoster Virus Vaccine in Adults Over 40 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30,000 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-10-06
• Primary completion: 2019-01-19
• Completion: 2019-01-19
• First posted: 2017-10-19
• Last updated: 2021-03-30

Locations

3 sites across 1 country: China