An Immunity Persistence Study of Booster Dose of Live Attenuated Varicella Vaccine
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
1 other identifier
interventional
414
1 country
1
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 persistence of live attenuated varicella vaccine at 6 and 10 years after booster dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2024
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2024
CompletedFirst Posted
Study publicly available on registry
July 3, 2024
CompletedStudy Start
First participant enrolled
September 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2031
January 27, 2025
January 1, 2025
4.2 years
June 26, 2024
January 23, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Seropositive rate
The seropositive rate of varicella-zoster virus (VZV) antibodies at 6 years after booster vaccination
at 6 years after booster vaccination
Seropositive rate
The seropositive rate of VZV antibodies at 10 years after booster vaccination
at 10 years after booster vaccination
GMT of VZV antibody
The GMT of VZV antibodies at 6 years after booster vaccination
at 6 years after booster vaccination
GMT of VZV antibody
The GMT of VZV antibodies at 10 years after booster vaccination
at 10 years after booster vaccination
Study Arms (1)
Experimental Group
EXPERIMENTALSubjects will be collected venous blood at 6 and 10 years after booster immunization.
Interventions
lyophilized powder, subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henan Provincial Center for Disease Control and Prevention
Zhengzhou, Henan, 450016, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lili Huang
Henan Provincial Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2024
First Posted
July 3, 2024
Study Start
September 16, 2024
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2031
Last Updated
January 27, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share