The Safety and Immunogenicity Research of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination
Primary Purpose
Varicella
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
HBV-3
HBV-6
varicella-3
varicella-6
Sponsored by
About this trial
This is an interventional prevention trial for Varicella
Eligibility Criteria
Inclusion Criteria:
-Participants from Shanxi province are between 1-12 years old are in good healthy determined through medical inquiry, physical examination, clinical judgment of the investor.
Exclusion Criteria:
- Having a fever (axillary temperature>37.0℃) before enrollment;
- Having a disease history of seizures, brain disease and the vaccination history of allergies and convulsions;
- Antibiotics allergy;
- Having a problem of intramuscular injection because thrombocytopenia or other blood coagulation disorder;
- Having immunodeficiency or under immunosuppression therapy, radiation therapy;
- Having respiratory diseases, acute infection, chronic disease and HIV infection;
- Having systemic skin rash, skin tinea, herpes;
- Chronic liver and kidney disease;
- Heart disease, and severe hypertension;
- Have received whole blood, plasma or immunoglobulin therapy 3 months before enrollment;
- Have received other live attenuated vaccine vaccination in 30 days before enrollment;
- Had been infected with Varicella virus and displayed symptom;
- Have received one or two dose of Varicella vaccine before enrollment;
- Congenital malformations, growth disorders such as Down's syndrome, diabetes, sickle cell anemia and nervous disorders
- Guillain-barre syndrome
- Thyroid resection history or thyroid disease treatment in the past 12 months;
- Asthma
- Have participated in other clinical research;
- Have serious adverse reactions after vaccination, such as allergies, hives, breathing difficulties, angioneurotic edema.
Sites / Locations
- Shanxi Centers for Disease Control and PreventionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Placebo Comparator
Experimental
Experimental
Arm Label
HBV-3
HBV-6
varicella-3
varicella-6
Arm Description
one dose HBV
one dose HBV
2 doses varicella vaccine either BCHT or Kengen and 3 month of the interval time
2 doses varicella vaccine either BCHT or Kengen and 6 month of the interval time
Outcomes
Primary Outcome Measures
Antibody titer after 2 doses lived attenuated varicella vaccination
Serums are collected from all participants before and 42 days after the first vaccination, and also 42 days after the second vaccination. The antibody titer to Varicella was detected through FAMA test.
Secondary Outcome Measures
Number of participants who have adverse reaction
The safety is evaluated by systemic and local reaction after each vaccination.
Full Information
NCT ID
NCT01866566
First Posted
May 28, 2013
Last Updated
June 25, 2013
Sponsor
Beijing Center for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT01866566
Brief Title
The Safety and Immunogenicity Research of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination
Official Title
Phase 4 Study of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Center for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Through evaluating the immunogenicity and safety for Varicella vaccine two doses immune procedure we could supply scientific and practical evidence for this two doses immune procedure promotion and management.
Detailed Description
Healthy participants aged 1 to 12 years old who had never received Varicella Vaccine are divided into three age groups, 1 to 3 years old group, 4 to 6 years old group and 7-12 years old group. In each age group, participants are randomly divided into experiment group and control groups.
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
1800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HBV-3
Arm Type
Placebo Comparator
Arm Description
one dose HBV
Arm Title
HBV-6
Arm Type
Placebo Comparator
Arm Description
one dose HBV
Arm Title
varicella-3
Arm Type
Experimental
Arm Description
2 doses varicella vaccine either BCHT or Kengen and 3 month of the interval time
Arm Title
varicella-6
Arm Type
Experimental
Arm Description
2 doses varicella vaccine either BCHT or Kengen and 6 month of the interval time
Intervention Type
Biological
Intervention Name(s)
HBV-3
Intervention Description
Give a single 0.5 mL HBV and get blood samples at 0,1.5,4.5 month
Intervention Type
Biological
Intervention Name(s)
HBV-6
Intervention Description
Give a single 0.5 mL HBV and get blood samples at 0,1.5,7.5 month
Intervention Type
Biological
Intervention Name(s)
varicella-3
Intervention Description
Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,4.5 month
Intervention Type
Biological
Intervention Name(s)
varicella-6
Intervention Description
Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,7.5 month
Primary Outcome Measure Information:
Title
Antibody titer after 2 doses lived attenuated varicella vaccination
Description
Serums are collected from all participants before and 42 days after the first vaccination, and also 42 days after the second vaccination. The antibody titer to Varicella was detected through FAMA test.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of participants who have adverse reaction
Description
The safety is evaluated by systemic and local reaction after each vaccination.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Number of participants who catch chickenpox
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-Participants from Shanxi province are between 1-12 years old are in good healthy determined through medical inquiry, physical examination, clinical judgment of the investor.
Exclusion Criteria:
Having a fever (axillary temperature>37.0℃) before enrollment;
Having a disease history of seizures, brain disease and the vaccination history of allergies and convulsions;
Antibiotics allergy;
Having a problem of intramuscular injection because thrombocytopenia or other blood coagulation disorder;
Having immunodeficiency or under immunosuppression therapy, radiation therapy;
Having respiratory diseases, acute infection, chronic disease and HIV infection;
Having systemic skin rash, skin tinea, herpes;
Chronic liver and kidney disease;
Heart disease, and severe hypertension;
Have received whole blood, plasma or immunoglobulin therapy 3 months before enrollment;
Have received other live attenuated vaccine vaccination in 30 days before enrollment;
Had been infected with Varicella virus and displayed symptom;
Have received one or two dose of Varicella vaccine before enrollment;
Congenital malformations, growth disorders such as Down's syndrome, diabetes, sickle cell anemia and nervous disorders
Guillain-barre syndrome
Thyroid resection history or thyroid disease treatment in the past 12 months;
Asthma
Have participated in other clinical research;
Have serious adverse reactions after vaccination, such as allergies, hives, breathing difficulties, angioneurotic edema.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nianmin Shi
Phone
86-010-67773550
Email
cycdc2011@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Li
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nianmin Shi
Organizational Affiliation
Beijing Chaoyang District Centers for Disease Control and Prevention
Official's Role
Study Chair
Facility Information:
Facility Name
Shanxi Centers for Disease Control and Prevention
City
Yuncheng
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li
First Name & Middle Initial & Last Name & Degree
Guohua Li
12. IPD Sharing Statement
Learn more about this trial
The Safety and Immunogenicity Research of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination
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