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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
Sponsor:
Information provided by (Responsible Party):
Sinovac (Dalian) Vaccine Technology Co., Ltd.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine in healthy children.

Condition or disease Intervention/treatment Phase
Varicella Biological: Investigational live attenuated varicella vaccine Biological: diluent of lyophilized vaccine Phase 3

Detailed Description:
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.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chickenpox Shingles

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Group
  • Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0;
  • Intervention: investigational live attenuated varicella vaccine;
 Biological: Investigational live attenuated varicella vaccine
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sham Comparator: Control Group
  • Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0;
  • Intervention: diluent of lyophilized vaccine;
 Biological: diluent of lyophilized vaccine
The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. The incidences of adverse events (AEs) of each group [ Time Frame: 30 days ]
    AEs occurred within 30 days after injection will be collected.

  2. The incidences of serious adverse events (SAEs) of each group [ Time Frame: 6 months ]
    SAEs occurred within 6 months after injection will be collected.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Investigators
Principal Investigator: Shengli Xia Henan Provincial Center for Disease Control and Prevention
More Information
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Responsible Party: Sinovac (Dalian) Vaccine Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02981836     History of Changes
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

Keywords provided by Sinovac (Dalian) Vaccine Technology Co., Ltd.:
live attenuated varicella vaccine
protective effect
safety
immunogenicity
child

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
 Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs