Back to resultsSafety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old
Primary Purpose
Varicella
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd.
Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd
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:
- Disease history or vaccine history of chickenpox or shingles;
- Have fever before vaccination, 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 severe allergy and asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and abdominal pain;
- 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) that could not be controlled by drugs, diabetes, liver and kidney diseases, malignant tumors, etc.;
- Family history of psychosis,severe neurological disease (epilepsy, convulsions or twitching) 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 6 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group with the immunization course of 0,28 days or 0,56 days
Control Group
Arm Description
1240 subjects (including 620 children aged 13-17 years and 620 adults aged 18 years and older) will receive two doses of experimental vaccine with the immunization course of 0,28 days or 0,56 days.
1240 subjects (including 620 children aged 13-17 years and 620 adults aged 18 years and older) will receive two doses of control vaccine with the immunization course of 0,28 days or 0,56 days.
Outcomes
Primary Outcome Measures
Seroconversion rate of HI antibody
The seroconversion rate of the antibody 42 days among all subjects after the second vaccination.
GMT of HI antibody
The GMT of the antibody 42 days among all subjects after the second vaccination.
Secondary Outcome Measures
Seroprotection rate of HI antibody
The seroprotection rate of the antibody 42 days among all subjects after the second vaccination.
Incidence of adverse reactions within 30 minutes after each dose
Incidence of adverse reactions within 30 minutes after each dose vaccination with immunization course of 0,28 days and 0,56 days.
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 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 and 0,56 days
Full Information
NCT ID
NCT05158777
First Posted
December 2, 2021
Last Updated
December 2, 2021
Sponsor
Shanghai Institute Of Biological Products
1. Study Identification
Unique Protocol Identification Number
NCT05158777
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 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Institute Of Biological Products
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 is a randomized, blind, controlled clinical trial of live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd. The purpose of this study is to evaluate the immunogenicity and safety of a two doses vaccination of investigational vaccine with 0,28 day and 0,56 day immunization schedule in population aged ≥13 years old.
Detailed Description
This study is a randomized, blind, controlled phase III clinical trial in population aged ≥13 years old. The experimental vaccine will be manufactured by Shanghai Institute of Biological Products Co.,Ltd.. A total of 2480 subjects aged 13 years and older will be enrolled with 1240 subjects in 13~17 years old group and1240 subjects in 18 years and older group. 1240 subjects in each age group would 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 or 0,56 days. In addition, 400 subjects from experimental group (100 subjects per subgroup) would be selected to collect blood at 3 and 5 years after immunization to evaluate immune persistence of live attenuated varicella vaccines.
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
2480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group with the immunization course of 0,28 days or 0,56 days
Arm Type
Experimental
Arm Description
1240 subjects (including 620 children aged 13-17 years and 620 adults aged 18 years and older) will receive two doses of experimental vaccine with the immunization course of 0,28 days or 0,56 days.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
1240 subjects (including 620 children aged 13-17 years and 620 adults aged 18 years and older) will receive two doses of control vaccine with the immunization course of 0,28 days or 0,56 days.
Intervention Type
Biological
Intervention Name(s)
Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd.
Intervention Description
live varicella-zoster virus in 0.5 mL of sucrose, sodium chloride, potassium chloride, sodium glutamate, 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 0.5 mL of mannitol, dextrose tincture, sucrose, trehalose, human serum albumin and injection water per injection
Primary Outcome Measure Information:
Title
Seroconversion rate of HI antibody
Description
The seroconversion rate of the antibody 42 days among all subjects after the second vaccination.
Time Frame
Day 42 after the whole schedule
Title
GMT of HI antibody
Description
The GMT of the antibody 42 days among all subjects after the second vaccination.
Time Frame
Day 42 after the whole schedule
Secondary Outcome Measure Information:
Title
Seroprotection rate of HI antibody
Description
The seroprotection rate of the antibody 42 days among all subjects after the second vaccination.
Time Frame
Day 42 after the whole schedule
Title
Incidence of adverse reactions within 30 minutes after each dose
Description
Incidence of adverse reactions within 30 minutes after each dose vaccination with immunization course of 0,28 days and 0,56 days.
Time Frame
Within 30 minutes after each dose
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 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 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:
Disease history or vaccine history of chickenpox or shingles;
Have fever before vaccination, 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 severe allergy and asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and abdominal pain;
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) that could not be controlled by drugs, diabetes, liver and kidney diseases, malignant tumors, etc.;
Family history of psychosis,severe neurological disease (epilepsy, convulsions or twitching) 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 6 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng Fu
Phone
86-021-62800991
Email
fucheng@sinopharm.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dandan Chen
Phone
86-021-62750096
Email
chendandan3@sinopharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanxia Wang
Organizational Affiliation
Henan Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old
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