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Long-term Effectiveness of the Live Attenuated Herpes Zoster Vaccine

Recruitingn/aAges 40 Years - anyAllJiangsu Province Centers for Disease Control and …
NCT07585370 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a multicenter retrospective cohort study to evaluate the long-term effectiveness of the live attenuated herpes zoster vaccine within 6 years after vaccination. We plan to select 24,740 participants who were non-herpes zoster cases in the modified Full Analysis Set for Efficacy (E-mFAS) from the Phase III Clinical Trial (NCT04334577) of the live attenuated herpes zoster vaccine manufactured by Changchun BCHT Biotechnology Co. conducted during 2020-2021. In the original Phase III Clinical Trial, the participants were randomly assigned to the vaccine group and the placebo group at a 1:1 ratio to receive one dose of the live attenuated herpes zoster vaccine (with varicella-zoster virus \>=4.3 lg PFU per 0.5 mL dose) or one dose of placebo (with no varicella-zoster virus component), respectively. This study uses a stage-based design. In Stage 1, participants originally assigned to the

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Individuals included in the E-mFAS from the Phase III Clinical Trial (NCT04334577) of the live attenuated herpes zoster vaccine produced by Changchun BCHT biotechnology Co. conducted during 2020-2021. 2. Individuals who were able to complete the study with verbal informed consent. Exclusion Criteria: 1. Individuals who developed herpes zoster during the original Phase III Clinical Trial follow-up period. 2. Individuals who were known to have died before the retrospective study.
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What it tests

  • Attenuated Zoster Vaccine, Live
  • Matched Placebo Without Live Virus
  • Attenuated Zoster Vaccine, Live
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Where

1 site
Jiangsu Provincial Center for Diseases Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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