Status:
ENROLLING_BY_INVITATION
An Immunity Persistence Study of Booster Dose of Live Attenuated Varicella Vaccine
Lead Sponsor:
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Conditions:
Varicella
Eligibility:
All Genders
8-16 years
Phase:
PHASE4
Brief Summary
This an open-label phase Ⅳ clinical trial of live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The purpose of this study is to evaluate the immunity persis...
Detailed Description
A total of 792 subjects aged 2 to 6 years including in per-protocol set (PPS) of immunogenicity assessment from previous phase Ⅲ clinical trial were enrolled. About 3.0ml of venous blood was collected...
Eligibility Criteria
Inclusion
- Subjects in PPS of previous phase Ⅲ clinical trial of varicella vaccine;
- The subjects and/or guardian can understand and voluntarily sign the informed consent form;
- Proven legal identity.
Exclusion
- Beyond the blood collection window period;
- History of varicella or shingles;
- History of varicella vaccination since phase Ⅲ clinical trial;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
414 Patients enrolled
Trial Details
Trial ID
NCT06484686
Start Date
September 16 2024
End Date
December 1 2031
Last Update
January 27 2025
Active Locations (1)
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1
Henan Provincial Center for Disease Control and Prevention
Zhengzhou, Henan, China, 450016