NCT04072497

A Clinical Study of a Zoster Vaccine in Healthy Adults >= 40 Years

A Safety and Immunogenicity Study of a Zoster Vaccine in Healthy Adults >= 40 Years

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 522 (actual)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: 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. Most people 40 years of age or older had evidence of previous VZV infection. This study plans to have 522 adults above 40 years old involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated zoster vaccine. The investigational vaccine is produced by Shanghai Institute of Biological Products Co., Ltd. The safety and immunogenicity of the zoster vaccine is evaluated.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	One shot of the zoster vaccine	One shot of the zoster vaccine (with live virus \>=4.3 LgPFU per dose)
BIOLOGICAL	One shot of the varicella vaccine	One shot of the varicella vaccine (with live virus \>=3.3 LgPFU per dose)
BIOLOGICAL	one shot of placebo	one shot of placebo with no live virus

Timeline

• Start date: 2018-11-20
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2019-08-28
• Last updated: 2023-12-27

Locations

1 site across 1 country: China