An Immunity Persistence Study of Live Attenuated Varicella Vaccine
NCT ID: NCT05095701
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE4
703 participants
INTERVENTIONAL
2021-12-18
2025-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Experimental Group
349 subjects who enrolled in the experimental group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0\~3.5ml at 5 and 8 years after primary immunization.
Investigational Live Attenuated Varicella Vaccine
The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. Live attenuated varicella-virus in 0·5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride, sodium dihydrogen phosphate, potassium dihydrogen phosphate per injection.
Control Group
354 subjects who enrolled in the control group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0\~3.5ml at 5 and 8 years after primary immunization.
Placebo (Freeze Dired Dilution)
The placebo (freeze dired dilution) was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. and contained no active ingredient.It was 0·5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride and phosphate.
Interventions
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Investigational Live Attenuated Varicella Vaccine
The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. Live attenuated varicella-virus in 0·5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride, sodium dihydrogen phosphate, potassium dihydrogen phosphate per injection.
Placebo (Freeze Dired Dilution)
The placebo (freeze dired dilution) was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. and contained no active ingredient.It was 0·5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride and phosphate.
Eligibility Criteria
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Inclusion Criteria
* The subject and/or guardian can understand and voluntarily sign the informed consent form;
* Proven legal identity.
Exclusion Criteria
* History of varicella vaccination since phase Ⅲ clinical trial;
* Autoimmune disease or immunodeficiency / immunosuppression;
* History of immunosuppressive therapy 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.
1 Year
17 Years
ALL
Yes
Sponsors
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Sinovac (Dalian) Vaccine Technology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Lili Huang, Bachelor
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial Center for Disease Prevention and Control
Locations
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Xiangcheng County Center for Disease Control and Prevention
Xuchang, Henan, China
Biyang County Center for Disease Control and Prevention
Zhumadian, Henan, China
Countries
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Other Identifiers
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PRO-VZV-4004
Identifier Type: -
Identifier Source: org_study_id
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