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

May 27, 2013 updated by: Beijing Center for Disease Control and Prevention

Phase 4 Study of the Varicella Vaccine After the 2nd Dose Vaccination

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Chaoyang District Centers for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of varicella after 2 dose vaccination
Time Frame: 5 years
Detection the Varicella virus origin and virus types from illness cases in Chao yang district
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event rate of varicella vaccine after 2 dose injection
Time Frame: 5 years
Adverse event rate of varicella vaccine after 2 dose injection
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody titre of varicella vaccine after 2 dose injection
Time Frame: 6 monthes
Antibody titre of varicella vaccine after 2 dose injection
6 monthes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Center for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

April 3, 2013

First Submitted That Met QC Criteria

April 11, 2013

First Posted (Estimate)

April 12, 2013

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 27, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJCDPC-8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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