search
Back to results

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

Primary Purpose

Varicella

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
varicella vaccine
Sponsored by
Beijing Center for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Varicella

Eligibility Criteria

4 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beijing Chaoyang District Centers for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1 dose varicella vaccine

2 dose varicella vaccine

Arm Description

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

The provider never get the varicella vaccine

Outcomes

Primary Outcome Measures

Incidence of varicella after 2 dose vaccination
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
Adverse event rate of varicella vaccine after 2 dose injection

Full Information

First Posted
April 3, 2013
Last Updated
May 27, 2013
Sponsor
Beijing Center for Disease Control and Prevention
search

1. Study Identification

Unique Protocol Identification Number
NCT01830283
Brief Title
The Safety, Immunogenicity and Immune Effect Research of the Varicella Vaccine After the 2nd Dose Vaccination
Official Title
Phase 4 Study of the Varicella Vaccine After the 2nd Dose Vaccination
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Center for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 dose varicella vaccine
Arm Type
Active Comparator
Arm Description
The providers would get the 2nd dose since they had one dose varicella vaccine
Arm Title
2 dose varicella vaccine
Arm Type
Experimental
Arm Description
The provider never get the varicella vaccine
Intervention Type
Biological
Intervention Name(s)
varicella vaccine
Intervention Description
The providers would get varicella vaccine
Primary Outcome Measure Information:
Title
Incidence of varicella after 2 dose vaccination
Description
Detection the Varicella virus origin and virus types from illness cases in Chao yang district
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Adverse event rate of varicella vaccine after 2 dose injection
Description
Adverse event rate of varicella vaccine after 2 dose injection
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Antibody titre of varicella vaccine after 2 dose injection
Description
Antibody titre of varicella vaccine after 2 dose injection
Time Frame
6 monthes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nianmin Shi
Organizational Affiliation
Beijing Chaoyang District Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chaoyang District Centers for Disease Control and Prevention
City
Beijing
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs