A Blind, Randomized and Controlled Study of Live Attenuated Varicella Vaccines
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ClinicalTrials.gov Identifier: NCT02981836 |
Recruitment Status :
Completed
First Posted : December 5, 2016
Last Update Posted : October 26, 2017
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Condition or disease | Intervention/treatment | Phase |
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Varicella | Biological: Investigational live attenuated varicella vaccine Biological: diluent of lyophilized vaccine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5997 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Blind, Randomized and Controlled Clinical Trial to Evaluate the Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccines for Healthy Children |
Actual Study Start Date : | August 2016 |
Actual Primary Completion Date : | June 2017 |
Actual Study Completion Date : | September 2017 |

Arm | Intervention/treatment |
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Experimental: Experimental Group
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Biological: Investigational live attenuated varicella vaccine
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. |
Sham Comparator: Control Group
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Biological: diluent of lyophilized vaccine
The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. |
- The incidences of varicella of each group [ Time Frame: ≥30 cases reported 30 days after injection ]The first 30 cases of varicella occurred 30 days after injection will be collected.
- The protection rate of the vaccine [ Time Frame: ≥30 cases reported after 30 days of the injection ]The protection rate will be calculated based on the reported cases occurred 30 days after injection.
- The incidences of adverse events (AEs) of each group [ Time Frame: 30 days ]AEs occurred within 30 days after injection will be collected.
- The incidences of serious adverse events (SAEs) of each group [ Time Frame: 6 months ]SAEs occurred within 6 months after injection will be collected.
- The seroconversion rate of the immunogenicity group [ Time Frame: 30 days after injection ]Seroconversion rate of the immonogenicity group 30 days after injection will be collected.
- The geometric mean titer (GMT) of the immunogenicity group [ Time Frame: 30 days ]Geometric mean titer (GMT) of the immonogenicity group will be collected before and 30 days after injection.
- The geometric mean fold increase (GMI) of the immunogenicity group [ Time Frame: 30 days after injection ]Geometric mean fold increse (GMI) of the immonogenicity group will be calculated based on the geometric mean titer.

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Ages Eligible for Study: | 1 Year to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy volunteer between 1 - 12 years old;
- 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:
- Prior vaccination with varicella vaccine or with history of varicella zoster virus (VZV) infection;
- 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;
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Receipt of any of the following products:
- Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- Any live attenuated vaccine within 1 month prior to study entry;
- 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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981836
China, Henan | |
Xiangcheng County Center for Disease Control and Prevention | |
Xuchang, Henan, China, 461700 | |
Biyang County Center for Disease Control and Prevention | |
Zhumadian, Henan, China, 463700 |
Principal Investigator: | Shengli Xia | Henan Provincial Center for Disease Control and Prevention |
Responsible Party: | Sinovac (Dalian) Vaccine Technology Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT02981836 |
Other Study ID Numbers: |
PRO-VZV-3001 |
First Posted: | December 5, 2016 Key Record Dates |
Last Update Posted: | October 26, 2017 |
Last Verified: | November 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
live attenuated varicella vaccine protective effect safety immunogenicity child |
Chickenpox Herpes Zoster Varicella Zoster Virus Infection Herpesviridae Infections DNA Virus Infections |
Virus Diseases Infections Vaccines Immunologic Factors Physiological Effects of Drugs |