The Safety and Immunogenicity Research of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination
NCT ID: NCT01866566
Last Updated: 2013-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
1800 participants
INTERVENTIONAL
2013-06-30
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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HBV-3
one dose HBV
HBV-3
Give a single 0.5 mL HBV and get blood samples at 0,1.5,4.5 month
HBV-6
one dose HBV
HBV-6
Give a single 0.5 mL HBV and get blood samples at 0,1.5,7.5 month
varicella-3
2 doses varicella vaccine either BCHT or Kengen and 3 month of the interval time
varicella-3
Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,4.5 month
varicella-6
2 doses varicella vaccine either BCHT or Kengen and 6 month of the interval time
varicella-6
Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,7.5 month
Interventions
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HBV-3
Give a single 0.5 mL HBV and get blood samples at 0,1.5,4.5 month
HBV-6
Give a single 0.5 mL HBV and get blood samples at 0,1.5,7.5 month
varicella-3
Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,4.5 month
varicella-6
Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,7.5 month
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Having a disease history of seizures, brain disease and the vaccination history of allergies and convulsions;
3. Antibiotics allergy;
4. Having a problem of intramuscular injection because thrombocytopenia or other blood coagulation disorder;
5. Having immunodeficiency or under immunosuppression therapy, radiation therapy;
6. Having respiratory diseases, acute infection, chronic disease and HIV infection;
7. Having systemic skin rash, skin tinea, herpes;
8. Chronic liver and kidney disease;
9. Heart disease, and severe hypertension;
10. Have received whole blood, plasma or immunoglobulin therapy 3 months before enrollment;
11. Have received other live attenuated vaccine vaccination in 30 days before enrollment;
12. Had been infected with Varicella virus and displayed symptom;
13. Have received one or two dose of Varicella vaccine before enrollment;
14. Congenital malformations, growth disorders such as Down's syndrome, diabetes, sickle cell anemia and nervous disorders
15. Guillain-barre syndrome
16. Thyroid resection history or thyroid disease treatment in the past 12 months;
17. Asthma
18. Have participated in other clinical research;
19. Have serious adverse reactions after vaccination, such as allergies, hives, breathing difficulties, angioneurotic edema.
1 Year
12 Years
ALL
Yes
Sponsors
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Beijing Center for Disease Control and Prevention
OTHER_GOV
Responsible Party
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Principal Investigators
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Nianmin Shi
Role: STUDY_CHAIR
Beijing Chaoyang District Centers for Disease Control and Prevention
Locations
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Shanxi Centers for Disease Control and Prevention
Yuncheng, Shanxi, China
Countries
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Central Contacts
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Li Li
Role: CONTACT
Facility Contacts
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Li
Role: primary
Other Identifiers
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BJCDPC-9
Identifier Type: -
Identifier Source: org_study_id
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