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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01830283
First received: April 3, 2013
Last updated: May 27, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Varicella
Biological: varicella vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 4 Study of the Varicella Vaccine After the 2nd Dose Vaccination

Resource links provided by NLM:


Further study details as provided by Beijing Center for Disease Control and Prevention:

Primary Outcome Measures:
  • Incidence of varicella after 2 dose vaccination [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Detection the Varicella virus origin and virus types from illness cases in Chao yang district


Secondary Outcome Measures:
  • Adverse event rate of varicella vaccine after 2 dose injection [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Adverse event rate of varicella vaccine after 2 dose injection


Other Outcome Measures:
  • Antibody titre of varicella vaccine after 2 dose injection [ Time Frame: 6 monthes ] [ Designated as safety issue: No ]
    Antibody titre of varicella vaccine after 2 dose injection


Estimated Enrollment: 50000
Study Start Date: April 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 dose varicella vaccine
The providers would get the 2nd dose since they had one dose varicella vaccine
Biological: varicella vaccine
The providers would get varicella vaccine
Experimental: 2 dose varicella vaccine
The provider never get the varicella vaccine
Biological: varicella vaccine
The providers would get varicella vaccine

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

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01830283

Locations
China
Beijing Chaoyang District Centers for Disease Control and Prevention
Beijing, China
Sponsors and Collaborators
Beijing Center for Disease Control and Prevention
Investigators
Principal Investigator: Nianmin Shi Beijing Chaoyang District Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01830283     History of Changes
Other Study ID Numbers: BJCDPC-8
Study First Received: April 3, 2013
Last Updated: May 27, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Herpes Zoster
Chickenpox
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014