Long-term Effectiveness of the Live Attenuated Herpes Zoster Vaccine
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 Clinic
| Condition(s) | Herpes Zoster |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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), res |
| Who can participate | 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. |
| Ages | 40 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Jiangsu Province Centers for Disease Control and Prevention |
| Locations | Nanjing, Jiangsu, China |
| Start date | 2026-03-06 |
| NCT ID | NCT07585370 |
| Official listing | https://clinicaltrials.gov/study/NCT07585370 |