Trials / Completed
CompletedNCT04334577
Study on Efficacy of Attenuated Zoster Vaccine, Live
Evaluation of the Efficacy of Attenuated Zoster Vaccine, Live From Herpes Zoster in Adults Aged 40 Years or older---a Multicenter, Randomized, Double-blinded,Placebo-controlled Trial Phase III
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 25,000 (actual)
- Sponsor
- Changchun BCHT Biotechnology Co. · 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. 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.
Detailed description
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | live attenuated zoster vaccine | subcutaneous injection |
| BIOLOGICAL | placebo | subcutaneous injection |
Timeline
- Start date
- 2020-04-20
- Primary completion
- 2021-07-18
- Completion
- 2021-07-18
- First posted
- 2020-04-06
- Last updated
- 2021-12-08
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04334577. Inclusion in this directory is not an endorsement.