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

NCT ID: NCT01830283

Last Updated: 2013-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2018-04-30

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.

Conditions

Varicella

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1 dose varicella vaccine

The providers would get the 2nd dose since they had one dose varicella vaccine

Group Type: ACTIVE_COMPARATOR

varicella vaccine

Intervention Type: BIOLOGICAL

The providers would get varicella vaccine

2 dose varicella vaccine

The provider never get the varicella vaccine

Group Type: EXPERIMENTAL

varicella vaccine

Intervention Type: BIOLOGICAL

The providers would get varicella vaccine

Interventions

varicella vaccine

The providers would get varicella vaccine

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nianmin Shi

Role: PRINCIPAL_INVESTIGATOR

Beijing Chaoyang District Centers for Disease Control and Prevention

Locations

Beijing Chaoyang District Centers for Disease Control and Prevention

Beijing, , China

Countries

China

Other Identifiers

BJCDPC-8

Identifier Type: -

Identifier Source: org_study_id