Status:

UNKNOWN

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

Lead Sponsor:

Beijing Center for Disease Control and Prevention

Conditions:

Varicella

Eligibility:

All Genders

4-12 years

Phase:

PHASE4

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...

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 vaccina...

Eligibility Criteria

Inclusion

  • Participants were between 4-12 years old
  • Participants were in good healthy determined through medical history, physical examination, clinical judgment of the investor

Exclusion

  • 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

Key Trial Info

Start Date :

April 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2018

Estimated Enrollment :

50000 Patients enrolled

Trial Details

Trial ID

NCT01830283

Start Date

April 1 2013

End Date

April 1 2018

Last Update

May 29 2013

Active Locations (1)

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1

Beijing Chaoyang District Centers for Disease Control and Prevention

Beijing, China