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Trial record 1 of 14 for:    varivax | Chicken Pox | Phase 1
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A Safety Study of Live Attenuated Varicella Vaccines in Healthy Adults, Adolescents and Children

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.
 
ClinicalTrials.gov Identifier: NCT02965404
Recruitment Status : Completed
First Posted : November 16, 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 safety of a live attenuated varicella vaccine in healthy adults, adolescents, and children.

Condition or disease Intervention/treatment Phase
Varicella Biological: Investigational live attenuated varicella vaccine Biological: control live attenuated varicella vaccine Biological: diluent of lyophilized vaccine Phase 1

Detailed Description:
This study is a randomized, blind, single-center, controlled phase I clinical trial. The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The positive control is a commercialized live attenuated varicella vaccine manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP), and the negative 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, positive control group, or negative control group in the ratio 1:1:1.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 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 Safety of Live Attenuated Varicella Vaccines for Healthy Adults, Adolescents and Children
Study Start Date : April 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: 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.
Active Comparator: Positive Control Group
  • Single intramuscular injection of the control vaccine (0.5 ml) on Day 0;
  • Intervention: control live attenuated varicella vaccine.
 Biological: control live attenuated varicella vaccine
The control vaccine was manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP)
Sham Comparator: Negative 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


Outcome Measures
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Primary 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.


Secondary Outcome Measures :
  1. The incidences of abnormal results of lab tests [ Time Frame: 30 days ]
    Cases of abnormal results of laboratory tests will be collected.

  2. The incidences of serious adverse events (SAEs) of each group [ Time Frame: 30 days ]
    SAEs occurred within 30 days after injection will be collected.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteer between 1 - 49 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 infant 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;
  • Breast feeding, pregnant, or expected to conceive during the period of this trial;
  • 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 of the pre-immune test results of the following indexes of laboratory tests showed clinically significant abnormity:

    1. Blood routine examinations: hemoglobin (Hb), white blood cells (WBC) count;
    2. Blood biochemistry detections: alanine transferase (ALT), total bilirubin, blood urea nitrogen (BUN), creatinine;
    3. Urine routine tests: urine protein, urine glucose, urine erythrocyte
  • 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): NCT02965404


Locations
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China, Henan
Xiangcheng County Center for Disease Control and Prevention
Xuchang, Henan, China, 461700
Sponsors and Collaborators
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Investigators
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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: NCT02965404    
Other Study ID Numbers: PRO-VZV-1001
First Posted: November 16, 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
safety
adult
adolescent
child
Additional relevant MeSH terms:
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Chickenpox
Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
 Virus Diseases
Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs