An Immunity Persistence Study of Booster Dose of Live Attenuated Varicella Vaccine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Live Attenuated Varicella Vaccine.
- Who it may be relevant to
- Registry conditions: Varicella. Basic parameters: 8 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
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 at 6 and 10 years after booster immunization for antibody detection.
Interventions
- Biological Live Attenuated Varicella Vaccine
lyophilized powder, subcutaneous injection
Primary outcome measures
- Seropositive rate [Time frame: at 6 years after booster vaccination]
- Seropositive rate [Time frame: at 10 years after booster vaccination]
- GMT of VZV antibody [Time frame: at 6 years after booster vaccination]
- GMT of VZV antibody [Time frame: 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Henan Provincial Center for Disease Control and Prevention — Zhengzhou
Identifiers
NCT: NCT06484686 · PRO-VZV-4005