The Safety, Immunogenicity and Immune Effect Research of the Varicella Vaccine After the 2nd Dose Vaccination
Information source: Beijing Center for Disease Control and Prevention
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Varicella
Intervention: varicella vaccine (Biological)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: Beijing Center for Disease Control and Prevention Official(s) and/or principal investigator(s): Nianmin Shi, Principal Investigator, Affiliation: Beijing Chaoyang District Centers for Disease Control and Prevention
Summary
To investigate the safety, immunogenicity and immune effect of the Varicella vaccine after
the 2nd dose vaccination in Chao yang district, Bei jing, since the 2nd varicella
vaccination was promoted by Beijing Center for Disease Control and Prevention in November,
2012.
Clinical Details
Official title: Phase 4 Study of the Varicella Vaccine After the 2nd Dose Vaccination
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Incidence of varicella after 2 dose vaccination
Secondary outcome: Adverse event rate of varicella vaccine after 2 dose injection
Detailed description:
"Breakthrough" varicella cases and varicella cases were monitored to evaluate the protective
effective in a large population.
Make the basic evaluation of safety for the two dose of varicella vaccination
Monitoring the Varicella virus origin and virus types from illness cases in Chao yang
district
Make the evaluation of healthy costs reduce for the varicella emergency vaccination after
large number of varicella cases occurred.
Eligibility
Minimum age: 4 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Participants were between 4-12 years old
- Participants were in good healthy determined through medical history, 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 and mental 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 not received other vaccination in 7 days before enrollment
Locations and Contacts
Beijing Chaoyang District Centers for Disease Control and Prevention, Beijing, China
Additional Information
Starting date: April 2013
Last updated: May 27, 2013
|