Back to resultsA Safety Study of Live Attenuated Varicella Vaccines in Healthy Adults, Adolescents and Children
Primary Purpose
Varicella
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Investigational live attenuated varicella vaccine
control live attenuated varicella vaccine
diluent of lyophilized vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Varicella focused on measuring live attenuated varicella vaccine, safety, adult, adolescent, child
Eligibility 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:
- 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 of the pre-immune test results of the following indexes of laboratory tests showed clinically significant abnormity:
- Blood routine examinations: hemoglobin (Hb), white blood cells (WBC) count;
- Blood biochemistry detections: alanine transferase (ALT), total bilirubin, blood urea nitrogen (BUN), creatinine;
- 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;
Sites / Locations
- Xiangcheng County Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
Experimental Group
Positive Control Group
Negative Control Group
Arm Description
Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; Intervention: investigational live attenuated varicella vaccine.
Single intramuscular injection of the control vaccine (0.5 ml) on Day 0; Intervention: control live attenuated varicella vaccine.
Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0; Intervention: diluent of lyophilized vaccine.
Outcomes
Primary Outcome Measures
The incidences of adverse events (AEs) of each group
AEs occurred within 30 days after injection will be collected.
Secondary Outcome Measures
The incidences of abnormal results of lab tests
Cases of abnormal results of laboratory tests will be collected.
The incidences of serious adverse events (SAEs) of each group
SAEs occurred within 30 days after injection will be collected.
Full Information
NCT ID
NCT02965404
First Posted
November 14, 2016
Last Updated
October 24, 2017
Sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02965404
Brief Title
A Safety Study of Live Attenuated Varicella Vaccines in Healthy Adults, Adolescents and Children
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine in healthy adults, adolescents, and children.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella
Keywords
live attenuated varicella vaccine, safety, adult, adolescent, child
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0;
Intervention: investigational live attenuated varicella vaccine.
Arm Title
Positive Control Group
Arm Type
Active Comparator
Arm Description
Single intramuscular injection of the control vaccine (0.5 ml) on Day 0;
Intervention: control live attenuated varicella vaccine.
Arm Title
Negative Control Group
Arm Type
Sham Comparator
Arm Description
Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0;
Intervention: diluent of lyophilized vaccine.
Intervention Type
Biological
Intervention Name(s)
Investigational live attenuated varicella vaccine
Intervention Description
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
Intervention Type
Biological
Intervention Name(s)
control live attenuated varicella vaccine
Intervention Description
The control vaccine was manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP)
Intervention Type
Biological
Intervention Name(s)
diluent of lyophilized vaccine
Intervention Description
The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology
Primary Outcome Measure Information:
Title
The incidences of adverse events (AEs) of each group
Description
AEs occurred within 30 days after injection will be collected.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
The incidences of abnormal results of lab tests
Description
Cases of abnormal results of laboratory tests will be collected.
Time Frame
30 days
Title
The incidences of serious adverse events (SAEs) of each group
Description
SAEs occurred within 30 days after injection will be collected.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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:
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 of the pre-immune test results of the following indexes of laboratory tests showed clinically significant abnormity:
Blood routine examinations: hemoglobin (Hb), white blood cells (WBC) count;
Blood biochemistry detections: alanine transferase (ALT), total bilirubin, blood urea nitrogen (BUN), creatinine;
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengli Xia
Organizational Affiliation
Henan Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangcheng County Center for Disease Control and Prevention
City
Xuchang
State/Province
Henan
ZIP/Postal Code
461700
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Safety Study of Live Attenuated Varicella Vaccines in Healthy Adults, Adolescents and Children
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