An observational study in Herpes Zoster, sponsored by Jiangsu Province Centers for Disease Control and Prevention. Recruiting at 1 site in China. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Jiangsu Province Centers for Disease Control and Prevention · Observational
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 vaccine group and those originally assigned to the placebo group will be compared to assess the cumulative incidence of herpes zoster from the end of the original Phase III Clinical Trial in July 2021 to the marketing authorization of the vaccine in China in June 2023. In Stage 2, after marketing authorization of the vaccine in China in June 2023, a large proportion of the participants originally assigned to the placebo group received catch-up vaccination and thereby formed a catch-up vaccination group. These stage-specific groups will be compared to evaluate the relative waning of protection in participants who received catch-up vaccination compared with participants vaccinated in the original Phase III Clinical Trial. In addition, among participants originally assigned to the placebo group who received catch-up vaccination, the incidence of herpes zoster during the post-catch-up vaccination period will be compared with the incidence during their earlier placebo period before catch-up vaccination, in order to evaluate the relative risk of herpes zoster under vaccinated versus placebo exposure. For this study, telephone surveys will be conducted using a standardized questionnaire to collect data on herpes zoster occurrence from participants, with verbal informed consent obtained prior to the survey. Face-to-face interviews will also be conducted to verify reported herpes zoster cases. Moreover, their past medical history and lifestyle information will be collected.
299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.
This study's planned enrollment of 24,740 is above the median of 290 across 42 observational studies indexed under Herpes Zoster.
Browse Herpes Zoster studies →Jiangsu Province Centers for Disease Control and Prevention is the lead sponsor of 77 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Attenuated Zoster Vaccine, Live
Biological: Matched Placebo Without Live Virus · Biological: Attenuated Zoster Vaccine, Live
This vaccine was produced by Changchun BCHT Biotechnology Co.
This placebo was produced by Changchun BCHT Biotechnology Co. for use in the Phase III Clinical Trial.
After market authorization in June 2023, part of the participants originally assigned to placebo received catch-up vaccination with the marketed live attenuated herpes zoster vaccine produced by Changchun BCHT Biotechnology Co.
Incidence of Herpes Zoster comparing participants originally assigned to the vaccine group and participants originally assigned to the placebo group
Time frame: From the end of the Phase III Clinical Trial in July 2021 to June 2023, before catch-up vaccination among placebo participants
Incidence of Herpes Zoster comparing participants in the original placebo group who received catch-up vaccination and participants originally assigned to the vaccine group under continued follow-up
Time frame: From June 2023 to the survey date in 2026
Incidence of Herpes Zoster among participants originally assigned to the placebo group, comparing the post-catch-up vaccination period with their earlier placebo period before catch-up vaccination
Time frame: From July 2021 to June 2023 for the earlier placebo period, and from June 2023 to the survey date in 2026 for the post-catch-up vaccination period
Incidence of Herpes Zoster stratified by sex
Time frame: From July 2021 to the survey date in 2026
Incidence of Herpes Zoster stratified by age group
Time frame: From July 2021 to the survey date in 2026
Incidence of Herpes Zoster stratified by chronic disease history
Time frame: From July 2021 to the survey date in 2026
Incidence of Herpes Zoster stratified by immunosuppressive treatment history
Time frame: From July 2021 to the survey date in 2026
Incidence of Herpes Zoster stratified by alcohol use
Time frame: From July 2021 to the survey date in 2026
Incidence of Herpes Zoster stratified by smoking status
Time frame: From July 2021 to the survey date in 2026
Incidence of Herpes Zoster stratified by physical activity or physical labor
Time frame: From July 2021 to the survey date in 2026
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jiangsu Province Centers for Disease Control and Prevention