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Trial record 12 of 31 for:    sinovac | China

A Blind, Randomized and Controlled Study of Live Attenuated Varicella Vaccines

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02981836
First Posted: December 5, 2016
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sinovac (Dalian) Vaccine Technology Co., Ltd.
November 28, 2016
December 5, 2016
October 26, 2017
August 2016
June 2017   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT02981836 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
A Blind, Randomized and Controlled Study of Live Attenuated Varicella Vaccines
A Blind, Randomized and Controlled Clinical Trial to Evaluate the Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccines for Healthy Children
The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine in healthy children.
This study is a randomized, blind, controlled phase III clinical trial. The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control is diluent of lyophilized vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. All participants are healthy, and will be randomly assigned into experimental group or control group in the ratio 1:1.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Varicella
  • Biological: Investigational live attenuated varicella vaccine
    The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
  • Biological: diluent of lyophilized vaccine
    The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
  • Experimental: Experimental Group
    • Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0;
    • Intervention: investigational live attenuated varicella vaccine;
    Intervention: Biological: Investigational live attenuated varicella vaccine
  • Sham Comparator: Control Group
    • Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0;
    • Intervention: diluent of lyophilized vaccine;
    Intervention: Biological: diluent of lyophilized vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5997
September 2017
June 2017   (Final data collection date for primary outcome measure)

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;
  • 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;
Sexes Eligible for Study: All
1 Year to 12 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT02981836
PRO-VZV-3001
Yes
Not Provided
Plan to Share IPD: No
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Not Provided
Principal Investigator: Shengli Xia Henan Provincial Center for Disease Control and Prevention
Sinovac (Dalian) Vaccine Technology Co., Ltd.
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP