Varicella
Conditions
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.
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
BIOLOGICALLive Attenuated Varicella Vaccine
lyophilized powder, subcutaneous injection
Sponsors
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seropositive rate | at 6 years after booster vaccination | The seropositive rate of varicella-zoster virus (VZV) antibodies at 6 years after booster vaccination |
| GMT of VZV antibody | at 6 years after booster vaccination | The GMT of VZV antibodies at 6 years after booster vaccination |
Countries
China
Outcome results
None listed