One shot of the varicella-zoster virus vaccine
BiologicalOne shot of the live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose)
NCT Number: NCT03314103
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.
Looking for future studies?
Notify Me40 year and older
All sexes
Interventional
Phase 3
Hunan Provincial Center for Disease Control and Prevention, Loudi, Hunan, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One shot of the live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose)
one shot of placebo with no live virus
Time frame: 30 days-2 years after the vaccination
The incidence of herpes zoster diagnosed in participants 30 days after vaccination.
Time frame: within 0 day -2 years after the vaccination
The incidence of herpes zoster diagnosed in participants after vaccination.
Time frame: 30 days-2 years after the vaccination
The incidence of laboratory-confirmed herpes zoster diagnosed in participants 30 days after vaccination.
Time frame: 30 days-2 years after the vaccination
The incidence of herpes zoster with severe postherpetic neuralgia (ZBPI scores≥3) in participants 30 days after vaccination.
Time frame: 30 days-2 years after the vaccination
The incidence of herpes zoster with postherpetic neuralgia in participants 30 days after vaccination.
Time frame: The incidence of herpes zoster with severe pain (ZBPI scores≥3) in participants 30 days after vaccination.
30 days-2 years after the vaccination
Time frame: 30 days after the vaccination
Geometric mean titre, geometric mean fold increase and four-fold increase rate of Serum for antibody responses at day 30 post-vaccination
Time frame: 6 months after the vaccination
geometric mean titre, geometric mean fold increase of Serum for antibody responses at 6 months post-vaccination
Time frame: 12 months after the vaccination
geometric mean titre, geometric mean fold increase of Serum for antibody responses at 12 months post-vaccination
Time frame: 24 months after the vaccination
geometric mean titre, geometric mean fold increase of Serum for antibody responses at 24 months post-vaccination
Time frame: within 14 days after the vaccination
Occurrence of solicited adverse reactions within 14 days after the vaccination.
Time frame: within 30 days after the vaccination
Occurrence of adverse reactions within 30 days after the vaccination.
Time frame: within 2 years
Occurrence of severe adverse reactions within 2 years after the vaccination.
Jiangsu Province Centers for Disease Control and Prevention
Network
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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