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

NCT04072497 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 522

Last updated 2023-12-27

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. 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

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

Sponsors & Collaborators

  • Shanghai Institute Of Biological Products

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2020-04-30
Completion
2020-04-30

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 NCT04072497 on ClinicalTrials.gov