Clinical trial
An Open-label Clinical Trial to Evaluate the Immunity Persistence of Live Attenuated Varicella Vaccine at 6 and 10 Years After Booster Dose Immunization With Live Attenuated Varicella Vaccine
Name
PRO-VZV-4005
Description
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 persistence of live attenuated varicella vaccine at 6 and 10 years after booster dose.
Trial arms
Trial start
2024-09-01
Estimated PCD
2026-09-01
Trial end
2028-09-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Live Attenuated Varicella Vaccine
lyophilized powder, subcutaneous injection
Arms:
Experimental Group
Size
414
Primary endpoint
Seropositive rate
at 6 years after booster vaccination
Seropositive rate
at 10 years after booster vaccination
GMT of VZV antibody
at 6 years after booster vaccination
GMT of VZV antibody
at 10 years after booster vaccination
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 414, 'type': 'ESTIMATED'}}
Updated at
2024-07-02
1 organization
1 product
1 indication
Organization
Sinovac Vaccine TechnologyIndication
Chickenpox