Status:
UNKNOWN
The Safety and Immunogenicity Research of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination
Lead Sponsor:
Beijing Center for Disease Control and Prevention
Conditions:
Varicella
Eligibility:
All Genders
1-12 years
Phase:
PHASE4
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 ma...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2016
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT01866566
Start Date
June 1 2013
End Date
January 1 2016
Last Update
June 26 2013
Active Locations (1)
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1
Shanxi Centers for Disease Control and Prevention
Yuncheng, Shanxi, China