A Phase 4 interventional study of Live Attenuated Varicella Vaccine in Varicella, sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd.. Enrolling by invitation at 1 site in China. Open to participants aged 8 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd. (part of Sinovac Biotech Co., Ltd) · Phase 4, Interventional, and Prevention
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.
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.
180 studies on the registry are indexed under Chickenpox; 28 are open to participants now.
This study's planned enrollment of 414 is below the median of 475 across 149 interventional studies indexed under Chickenpox.
Browse Chickenpox studies →Sinovac (Dalian) Vaccine Technology Co., Ltd. is the lead sponsor of 20 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be collected venous blood at 6 and 10 years after booster immunization.
Biological: Live Attenuated Varicella Vaccine
lyophilized powder, subcutaneous injection
Seropositive rate
The seropositive rate of varicella-zoster virus (VZV) antibodies at 6 years after booster vaccination
Time frame: at 6 years after booster vaccination
Seropositive rate
The seropositive rate of VZV antibodies at 10 years after booster vaccination
Time frame: at 10 years after booster vaccination
GMT of VZV antibody
The GMT of VZV antibodies at 6 years after booster vaccination
Time frame: at 6 years after booster vaccination
GMT of VZV antibody
The GMT of VZV antibodies at 10 years after booster vaccination
Time frame: at 10 years after booster vaccination
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Dec 2028, 51 months after the start.
Of 14 phase 4 interventional studies under Chickenpox, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 22. This study's planned 51 months is above that.
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No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: Chickenpox Vaccine
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