Back to resultsSafety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old
Primary Purpose
Varicella
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd
Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd
Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Varicella
Eligibility Criteria
Inclusion Criteria:
- Healthy population aged 13 years and above;
- Proven legal identity;
- The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 13-17 years, both subjects and guardians need to sign the informed consent form);
Exclusion Criteria:
- History of chickenpox or shingles;
- Axillary temperature >37.0°C;
- Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 6 months;
- History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
- Autoimmune disease or immunodeficiency / immunosuppression;
- Severe chronic diseases, severe cardiovascular diseases,hypertension(adult field measurement: SBP ≥140mmHg or diastolic blood pressure ≥90mmHg)and diabetes that cannot be controlled by drugs, liver or kidney diseases;
- Family history of psychosis,severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- Thyroid disease or history of thyroidectomy, asplenia, functional asplenia,asplenia or splenectomy resulting from any condition;
- Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
- Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- History of alcohol or drug abuse;
- Receipt of blood products within in the past 3 months;
- Participating in other drug/vaccine clinical trial;
- Receipt of attenuated live vaccines in the past 28 days;
- Receipt of inactivated or subunit vaccines in the past 7 days;
- Onset of various acute or chronic diseases within 7 days prior to the study;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Sites / Locations
- Yucheng Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Placebo Comparator
Arm Label
Experimental Group with the immunization course of 0,28 days, 0,42 days or 0,56 days
Control Group
Experimental Group with the immunization course of 0, 70 days
Placebo group
Arm Description
960 subjects (including 480 children aged 13-17 years and 480 adults aged 18 years and older) will receive two doses of experimental vaccine with the immunization course of 0,28 days, 0,42 days or 0,56 days.
960 subjects (including 480 children aged 13-17 years and 480 adults aged 18 years and older) will receive two doses of control vaccine with the immunization course of 0,28 days, 0,42 days or 0,56 days.
320 subjects (including 160 children aged 13-17 years and 160 adults aged 18 years and older) will receive two doses of the experimental vaccine with the immunization course of 0, 70 days.
160 subjects (including 80children aged 13-17 years and 80 adults aged 18 years and older) will receive two doses of the placebo with the immunization course of 0, 70 days.
Outcomes
Primary Outcome Measures
Seroconversion rate of the antibody
The seroconversion rate of the antibody 28 days among all subjects after the second vaccination.
GMT of the antibody
The GMT of the antibody 28 days among all subjects after the second vaccination.
Secondary Outcome Measures
GMI of the antibody
GMI of the antibody 28 days among all subjects after the second vaccination.
Seroconversion rate, positive rate, GMT and GMI of the antibody
Seroconversion rate, positive rate, GMT and GMI of the antibody among all subjects on day 28,day 42 and day 56 after the first vaccination.
Incidence of adverse reactions within 0~28 days after each dose
Incidence of adverse reactions within 0~28 days after each dose vaccination with immunization course of 0,28 days ,0,42 days and 0,56 days.
Incidence of adverse reactions within 0~14 days after each dose vaccination
Incidence of adverse reactions within 0~14 days after each dose vaccination with immunization course of 0,28 days ,0,42 days and 0,56 days
Incidence of grade 3 and above adverse reactions
Incidence of grade 3 and above adverse reactions within 0~28 days after each dose vaccination with immunization course of 0,28 days ,0,42 days and 0,56 days.
Incidence of serious adverse events
Incidence of serious adverse events from vaccination to 6 months after the second vaccination with immunization course of 0,28 days ,0,42 days and 0,56 days
Full Information
NCT ID
NCT05015686
First Posted
July 26, 2021
Last Updated
December 7, 2022
Sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05015686
Brief Title
Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old
Official Title
A Randomized, Blind, Controlled Clinical Trial to Evaluate Safety and Immunogenicity of Live Attenuated Varicella Vaccine After a Two-dose Vaccination Course in Healthy Population Aged ≥13 Years Old
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
February 9, 2022 (Actual)
Study Completion Date
September 20, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This a randomized, blind, controlled clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunogenicity of a two doses vaccination of investigational vaccine with 0,28 day, 0,42 day and 0,56 day immunization schedule in population aged ≥13 years old.
Detailed Description
This study is a randomized, blind, controlled phase # clinical trial in population aged ≥13 years old. The experimental vaccine will be manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.A total of 2400 subjects aged 13 years and older will be enrolled with1200 subjects in 13 ~ 17 years old group and1200 subjects in 18 years and older group.960 subjects in each age group will be randomly divided into experimental group and control group according to 1:1 ratio,and subjects will receive two doses of vaccine with the immunization course of 0,28 days, 0,42 days or 0,56 days. An additional 240 subjects in each age group will be randomly divided into experimental group and control group according to 2:1 ratio to receive two doses of the experimental vaccine or placebo with the immunization course of 0, 70 days.In addition,400 subjects including 320 people of experimental group in different immunization course according to the difference of age and 80 people of placebo group according to the difference of age will be selected to collect blood about 3ml each time to evaluate immunity persistence of live attenuated varicella vaccines at 3 and 5 years after the whole immunization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group with the immunization course of 0,28 days, 0,42 days or 0,56 days
Arm Type
Experimental
Arm Description
960 subjects (including 480 children aged 13-17 years and 480 adults aged 18 years and older) will receive two doses of experimental vaccine with the immunization course of 0,28 days, 0,42 days or 0,56 days.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
960 subjects (including 480 children aged 13-17 years and 480 adults aged 18 years and older) will receive two doses of control vaccine with the immunization course of 0,28 days, 0,42 days or 0,56 days.
Arm Title
Experimental Group with the immunization course of 0, 70 days
Arm Type
Experimental
Arm Description
320 subjects (including 160 children aged 13-17 years and 160 adults aged 18 years and older) will receive two doses of the experimental vaccine with the immunization course of 0, 70 days.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
160 subjects (including 80children aged 13-17 years and 80 adults aged 18 years and older) will receive two doses of the placebo with the immunization course of 0, 70 days.
Intervention Type
Biological
Intervention Name(s)
Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd
Intervention Description
live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection
Intervention Type
Biological
Intervention Name(s)
Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd
Intervention Description
live varicella-zoster virus in trehalose,human serum albumin,sodium glutamate,sucrose,glucose,carbamide,arginine and injection water per injection
Intervention Type
Biological
Intervention Name(s)
Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd
Intervention Description
live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Sodium chloride and distilled water
Primary Outcome Measure Information:
Title
Seroconversion rate of the antibody
Description
The seroconversion rate of the antibody 28 days among all subjects after the second vaccination.
Time Frame
Day 28 after the whole schedule
Title
GMT of the antibody
Description
The GMT of the antibody 28 days among all subjects after the second vaccination.
Time Frame
Day 28 after the whole schedule
Secondary Outcome Measure Information:
Title
GMI of the antibody
Description
GMI of the antibody 28 days among all subjects after the second vaccination.
Time Frame
Day 28 after the whole schedule
Title
Seroconversion rate, positive rate, GMT and GMI of the antibody
Description
Seroconversion rate, positive rate, GMT and GMI of the antibody among all subjects on day 28,day 42 and day 56 after the first vaccination.
Time Frame
Day 28,Day 42 and day 56 after the first vaccination
Title
Incidence of adverse reactions within 0~28 days after each dose
Description
Incidence of adverse reactions within 0~28 days after each dose vaccination with immunization course of 0,28 days ,0,42 days and 0,56 days.
Time Frame
Within 0~28 days after each dose
Title
Incidence of adverse reactions within 0~14 days after each dose vaccination
Description
Incidence of adverse reactions within 0~14 days after each dose vaccination with immunization course of 0,28 days ,0,42 days and 0,56 days
Time Frame
Within 0~14 days after each dose
Title
Incidence of grade 3 and above adverse reactions
Description
Incidence of grade 3 and above adverse reactions within 0~28 days after each dose vaccination with immunization course of 0,28 days ,0,42 days and 0,56 days.
Time Frame
within 0~28 days after each dose
Title
Incidence of serious adverse events
Description
Incidence of serious adverse events from vaccination to 6 months after the second vaccination with immunization course of 0,28 days ,0,42 days and 0,56 days
Time Frame
From vaccination to 6 months after the second vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy population aged 13 years and above;
Proven legal identity;
The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 13-17 years, both subjects and guardians need to sign the informed consent form);
Exclusion Criteria:
History of chickenpox or shingles;
Axillary temperature >37.0°C;
Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 6 months;
History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
Autoimmune disease or immunodeficiency / immunosuppression;
Severe chronic diseases, severe cardiovascular diseases,hypertension(adult field measurement: SBP ≥140mmHg or diastolic blood pressure ≥90mmHg)and diabetes that cannot be controlled by drugs, liver or kidney diseases;
Family history of psychosis,severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
Thyroid disease or history of thyroidectomy, asplenia, functional asplenia,asplenia or splenectomy resulting from any condition;
Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
History of alcohol or drug abuse;
Receipt of blood products within in the past 3 months;
Participating in other drug/vaccine clinical trial;
Receipt of attenuated live vaccines in the past 28 days;
Receipt of inactivated or subunit vaccines in the past 7 days;
Onset of various acute or chronic diseases within 7 days prior to the study;
According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lili Huang, Bachelor
Organizational Affiliation
Henan Provincial Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yucheng Center for Disease Control and Prevention
City
Shangqiu
State/Province
Henan
ZIP/Postal Code
476300
Country
China
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old
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