The Safety, Immunogenicity and Immune Effect Research of the Varicella Vaccine After the 2nd Dose Vaccination

Phase 4

• Conditions: Varicella

• Registration Number: NCT01830283
• Lead Sponsor: Beijing Center for Disease Control and Prevention

Brief 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.

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.

Study Timeline

• Status Verified: 2013-04
• Study Start: 2013-04
• Study First Submitted: 2013-04-03
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-12
• Last Update Submitted: 2013-05-27
• Last Update Posted: 2013-05-29
• Primary Completion: 2013-06
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of varicella after 2 dose vaccination	5 years	Detection the Varicella virus origin and virus types from illness cases in Chao yang district

Secondary Outcome Measures

Name	Time	Method
Adverse event rate of varicella vaccine after 2 dose injection	5 years	Adverse event rate of varicella vaccine after 2 dose injection

Trial Locations

Locations (1)

Beijing Chaoyang District Centers for Disease Control and Prevention; 🇨🇳 Beijing, China