A Blind, Randomized and Controlled Study of Live Attenuated Varicella Vaccines
NCT ID: NCT02981836
Last Updated: 2017-10-26
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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COMPLETED
PHASE3
5997 participants
INTERVENTIONAL
2016-08-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Experimental Group
* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0;
* Intervention: investigational live attenuated varicella vaccine;
Investigational live attenuated varicella vaccine
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
Control Group
* Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0;
* Intervention: diluent of lyophilized vaccine;
diluent of lyophilized vaccine
The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
Interventions
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Investigational live attenuated varicella vaccine
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
diluent of lyophilized vaccine
The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
Eligibility Criteria
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Inclusion Criteria
* Proven legal identity;
* Guardian(s) of the volunteer and/or volunteers themselves should be capable of understanding the written consent form, and such form should be signed before the volunteer being included into this study;
Exclusion Criteria
* Axillaty temperature \> 37.0 °C;
* History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
* History of epilepsy, seizures or convulsions, or a family history of mental illness, autoimmune disease or immunodeficiency;
* Severe malnutrition, congenital malformation, developmental disorders, or serious chronic diseases;
* Acute disease or acute stage of chronic disease within 7 days prior to study entry;
* Receipt of any of the following products:
1. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
2. Any live attenuated vaccine within 1 month prior to study entry;
3. Any blood product, immunosuppressant, hormone, or other investigational medicine(s) within 30 days prior to study entry;
* Any significant abnormity of heart, lung, skin, or pharynx;
* Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;
1 Year
12 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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Shengli Xia
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial Center for Disease Control and Prevention
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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References
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Zhang Y, Wang L, Wang Y, Zhang W, Jia N, Xie Z, Huang L, You W, Lu W, Li E, Gao F, Hu Y, Meng F, Xia S. Immunogenicity and Safety of a Booster Dose of Live Attenuated Varicella Vaccine, and Immune Persistence of a Primary Dose for Children Aged 2 to 6 Years. Vaccines (Basel). 2022 Apr 22;10(5):660. doi: 10.3390/vaccines10050660.
Hao B, Chen Z, Zeng G, Huang L, Luan C, Xie Z, Chen J, Bao M, Tian X, Xu B, Wang Y, Wu J, Xia S, Yuan L, Huang J. Efficacy, safety and immunogenicity of live attenuated varicella vaccine in healthy children in China: double-blind, randomized, placebo-controlled clinical trial. Clin Microbiol Infect. 2019 Aug;25(8):1026-1031. doi: 10.1016/j.cmi.2018.12.033. Epub 2019 Jan 4.
Other Identifiers
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PRO-VZV-3001
Identifier Type: -
Identifier Source: org_study_id