Back to resultsA Study of Combined Immunization With Live Attenuated Varicella Vaccine and Inactivated Hepatitis A Vaccine
Primary Purpose
Varicella
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
The live attenuated varicella vaccine and the inactivated hepatitis A vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Varicella
Eligibility Criteria
Inclusion Criteria:
- Healthy child aged 1 year old (12-15 months old);
- Proven legal identity;
- The subjects'guardians should be capable of understanding the informed consent form, and such form should be signed prior to enrolment.
Exclusion Criteria:
- History of vaccination of varicella vaccine or hepatitis A vaccine.
- Previous history of varicella infection or hepatitis A infection;
- 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;
- Thyroid disease or history of thyroidectomy, asplenia,functional asplenia,asplenia or splenectomy resulting from any condition;
- Suffering from serious chronic diseases, serious cardiovascular diseases, liver and kidney diseases, malignant tumors, etc;
- Family history of psychosis,severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- 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) within 6 months before enrollment;
- Receipt of blood products within the past 3 months;
- Receipt of other investigational vaccines or drugs within 28 days prior to receiving the investigational vaccine;
- 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;
- Armpit temperature in subjects with fever prior to vaccination with the investigational vaccine. 37.4 ℃;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial
Sites / Locations
- Feicheng Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
The combined immunization group
The Non-combined immunization group
Arm Description
225 participants received one dose of live attenuated varicella vaccine and the first dose inactivated hepatitis A vaccine on day 0 and the second dose of inactivated hepatitis A vaccine on day 180.
225 participants received one dose of live attenuated varicella vaccine on day 0,the first dose of inactivated hepatitis A vaccine on day 42 and the second dose of inactivated hepatitis A vaccine on day 222.
Outcomes
Primary Outcome Measures
Seroconversion rates of the varicella antibody
Seroconversion rate of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
Seroconversion rates of anti-HAV antibody
Seroconversion rate of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.
Secondary Outcome Measures
Seropositive rates of varicella antibody
Seropositive rates of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
GMT of varicella antibody
GMT of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
GMI of varicella antibody
GMI of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
Seropositive rates of anti-HAV antibody
Seropositive rates of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.
GMC of anti-HAV antibody
GMC of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.
GMI of anti-HAV antibody
GMI of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.
The incidence of adverse events
Incidence of adverse events within 0-42 days (or 0-30 days) after each dose of vaccine.
The incidence of local and systemic solicitation adverse reactions
The incidence of local and systemic solicitation adverse reactions within 0-14 days (or 0-7 days) after each dose of vaccine.
The incidence of serious adverse events (SAE)
The incidence of serious adverse events (SAE) within 42 days (or 30 days) after administration of each dose of vaccine.
Full Information
NCT ID
NCT05526820
First Posted
August 31, 2022
Last Updated
August 31, 2022
Sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05526820
Brief Title
A Study of Combined Immunization With Live Attenuated Varicella Vaccine and Inactivated Hepatitis A Vaccine
Official Title
A Randomized, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Inactivated Hepatitis A Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
April 8, 2021 (Actual)
Study Completion Date
February 27, 2022 (Actual)
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 study is a randomized and controlled Phase IV clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of combined immunization with live attenuated varicella vaccine and inactivated hepatitis A vaccine in children aged 12-15 months.
Detailed Description
This study is a randomized and controlled phase IV clinical trial in children aged 1 year old (12-15 months).The purpose of this study is to evaluate the immunogenicity and safety of live attenuated varicella vaccine co-administration with inactivated hepatitis A vaccine .The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd,the inactivated hepatitis A vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 450 subjects aged 1 year old (12-15 months) were be enrolled.Subjects were be randomly divided into 2 groups in a ratio of 1:1.Subjects in the combined immunization group received one dose of live attenuated varicella vaccine and the first dose inactivated hepatitis A vaccine on day 0 and the second dose of inactivated hepatitis A vaccine on day 180.Subjects in the Non-combined immunization group received one dose of live attenuated varicella vaccine on day 0,the first dose of inactivated hepatitis A vaccine on day 42 and the second dose of inactivated hepatitis A vaccine on day 222.
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 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The combined immunization group
Arm Type
Experimental
Arm Description
225 participants received one dose of live attenuated varicella vaccine and the first dose inactivated hepatitis A vaccine on day 0 and the second dose of inactivated hepatitis A vaccine on day 180.
Arm Title
The Non-combined immunization group
Arm Type
Active Comparator
Arm Description
225 participants received one dose of live attenuated varicella vaccine on day 0,the first dose of inactivated hepatitis A vaccine on day 42 and the second dose of inactivated hepatitis A vaccine on day 222.
Intervention Type
Biological
Intervention Name(s)
The live attenuated varicella vaccine and the inactivated hepatitis A vaccine
Intervention Description
The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd,the inactivated hepatitis A vaccine was manufactured by Sinovac Biotech Co., Ltd.
The live attenuated varicella vaccine: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.
The inactivated hepatitis A vaccine:250 U inactivated virus in 0.5mL of aluminium hydroxide solution per injection.
All subjects received hepatitis A vaccine in the upper left arm and varicella vaccine in the upper right arm.
Primary Outcome Measure Information:
Title
Seroconversion rates of the varicella antibody
Description
Seroconversion rate of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
Time Frame
42 days after immunization of live attenuated varicella vaccine
Title
Seroconversion rates of anti-HAV antibody
Description
Seroconversion rate of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.
Time Frame
30 days after full immunization with hepatitis A vaccine
Secondary Outcome Measure Information:
Title
Seropositive rates of varicella antibody
Description
Seropositive rates of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
Time Frame
42 days after immunization of live attenuated varicella vaccine
Title
GMT of varicella antibody
Description
GMT of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
Time Frame
42 days after immunization of live attenuated varicella vaccine
Title
GMI of varicella antibody
Description
GMI of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
Time Frame
42 days after immunization of live attenuated varicella vaccine
Title
Seropositive rates of anti-HAV antibody
Description
Seropositive rates of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.
Time Frame
30 days after full immunization with hepatitis A vaccine
Title
GMC of anti-HAV antibody
Description
GMC of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.
Time Frame
30 days after full immunization with hepatitis A vaccine
Title
GMI of anti-HAV antibody
Description
GMI of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.
Time Frame
30 days after full immunization with hepatitis A vaccine
Title
The incidence of adverse events
Description
Incidence of adverse events within 0-42 days (or 0-30 days) after each dose of vaccine.
Time Frame
within 0-42 days (or 0-30 days) after each dose of vaccine
Title
The incidence of local and systemic solicitation adverse reactions
Description
The incidence of local and systemic solicitation adverse reactions within 0-14 days (or 0-7 days) after each dose of vaccine.
Time Frame
Within 0-14 days (or 0-7 days) after each dose of vaccine
Title
The incidence of serious adverse events (SAE)
Description
The incidence of serious adverse events (SAE) within 42 days (or 30 days) after administration of each dose of vaccine.
Time Frame
Within 42 days (or 30 days) after administration of each dose of vaccine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy child aged 1 year old (12-15 months old);
Proven legal identity;
The subjects'guardians should be capable of understanding the informed consent form, and such form should be signed prior to enrolment.
Exclusion Criteria:
History of vaccination of varicella vaccine or hepatitis A vaccine.
Previous history of varicella infection or hepatitis A infection;
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;
Thyroid disease or history of thyroidectomy, asplenia,functional asplenia,asplenia or splenectomy resulting from any condition;
Suffering from serious chronic diseases, serious cardiovascular diseases, liver and kidney diseases, malignant tumors, etc;
Family history of psychosis,severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
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) within 6 months before enrollment;
Receipt of blood products within the past 3 months;
Receipt of other investigational vaccines or drugs within 28 days prior to receiving the investigational vaccine;
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;
Armpit temperature in subjects with fever prior to vaccination with the investigational vaccine. 37.4 ℃;
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
Dianmin Kang
Organizational Affiliation
Shandong Provincial Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Feicheng Center for Disease Control and Prevention
City
Tai'an
State/Province
Shandong
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of Combined Immunization With Live Attenuated Varicella Vaccine and Inactivated Hepatitis A Vaccine
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