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The Safety and Immunogenicity Research of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination

Primary Purpose

Varicella

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
HBV-3
HBV-6
varicella-3
varicella-6
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

1 Year - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

-Participants from Shanxi province are between 1-12 years old are in good healthy determined through medical inquiry, physical examination, clinical judgment of the investor.

Exclusion Criteria:

  1. Having a fever (axillary temperature>37.0℃) before enrollment;
  2. Having a disease history of seizures, brain disease and the vaccination history of allergies and convulsions;
  3. Antibiotics allergy;
  4. Having a problem of intramuscular injection because thrombocytopenia or other blood coagulation disorder;
  5. Having immunodeficiency or under immunosuppression therapy, radiation therapy;
  6. Having respiratory diseases, acute infection, chronic disease and HIV infection;
  7. Having systemic skin rash, skin tinea, herpes;
  8. Chronic liver and kidney disease;
  9. Heart disease, and severe hypertension;
  10. Have received whole blood, plasma or immunoglobulin therapy 3 months before enrollment;
  11. Have received other live attenuated vaccine vaccination in 30 days before enrollment;
  12. Had been infected with Varicella virus and displayed symptom;
  13. Have received one or two dose of Varicella vaccine before enrollment;
  14. Congenital malformations, growth disorders such as Down's syndrome, diabetes, sickle cell anemia and nervous disorders
  15. Guillain-barre syndrome
  16. Thyroid resection history or thyroid disease treatment in the past 12 months;
  17. Asthma
  18. Have participated in other clinical research;
  19. Have serious adverse reactions after vaccination, such as allergies, hives, breathing difficulties, angioneurotic edema.

Sites / Locations

  • Shanxi Centers for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Placebo Comparator

Experimental

Experimental

Arm Label

HBV-3

HBV-6

varicella-3

varicella-6

Arm Description

one dose HBV

one dose HBV

2 doses varicella vaccine either BCHT or Kengen and 3 month of the interval time

2 doses varicella vaccine either BCHT or Kengen and 6 month of the interval time

Outcomes

Primary Outcome Measures

Antibody titer after 2 doses lived attenuated varicella vaccination
Serums are collected from all participants before and 42 days after the first vaccination, and also 42 days after the second vaccination. The antibody titer to Varicella was detected through FAMA test.

Secondary Outcome Measures

Number of participants who have adverse reaction
The safety is evaluated by systemic and local reaction after each vaccination.

Full Information

First Posted
May 28, 2013
Last Updated
June 25, 2013
Sponsor
Beijing Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01866566
Brief Title
The Safety and Immunogenicity Research of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination
Official Title
Phase 4 Study of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2016 (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
Through evaluating the immunogenicity and safety for Varicella vaccine two doses immune procedure we could supply scientific and practical evidence for this two doses immune procedure promotion and management.
Detailed Description
Healthy participants aged 1 to 12 years old who had never received Varicella Vaccine are divided into three age groups, 1 to 3 years old group, 4 to 6 years old group and 7-12 years old group. In each age group, participants are randomly divided into experiment group and control groups.

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
Randomized
Enrollment
1800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HBV-3
Arm Type
Placebo Comparator
Arm Description
one dose HBV
Arm Title
HBV-6
Arm Type
Placebo Comparator
Arm Description
one dose HBV
Arm Title
varicella-3
Arm Type
Experimental
Arm Description
2 doses varicella vaccine either BCHT or Kengen and 3 month of the interval time
Arm Title
varicella-6
Arm Type
Experimental
Arm Description
2 doses varicella vaccine either BCHT or Kengen and 6 month of the interval time
Intervention Type
Biological
Intervention Name(s)
HBV-3
Intervention Description
Give a single 0.5 mL HBV and get blood samples at 0,1.5,4.5 month
Intervention Type
Biological
Intervention Name(s)
HBV-6
Intervention Description
Give a single 0.5 mL HBV and get blood samples at 0,1.5,7.5 month
Intervention Type
Biological
Intervention Name(s)
varicella-3
Intervention Description
Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,4.5 month
Intervention Type
Biological
Intervention Name(s)
varicella-6
Intervention Description
Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,7.5 month
Primary Outcome Measure Information:
Title
Antibody titer after 2 doses lived attenuated varicella vaccination
Description
Serums are collected from all participants before and 42 days after the first vaccination, and also 42 days after the second vaccination. The antibody titer to Varicella was detected through FAMA test.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of participants who have adverse reaction
Description
The safety is evaluated by systemic and local reaction after each vaccination.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Number of participants who catch chickenpox
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: -Participants from Shanxi province are between 1-12 years old are in good healthy determined through medical inquiry, 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 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 received other live attenuated vaccine vaccination in 30 days before enrollment; Had been infected with Varicella virus and displayed symptom; Have received one or two dose of Varicella vaccine before enrollment; Congenital malformations, growth disorders such as Down's syndrome, diabetes, sickle cell anemia and nervous disorders Guillain-barre syndrome Thyroid resection history or thyroid disease treatment in the past 12 months; Asthma Have participated in other clinical research; Have serious adverse reactions after vaccination, such as allergies, hives, breathing difficulties, angioneurotic edema.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nianmin Shi
Phone
86-010-67773550
Email
cycdc2011@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Li
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
Study Chair
Facility Information:
Facility Name
Shanxi Centers for Disease Control and Prevention
City
Yuncheng
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li
First Name & Middle Initial & Last Name & Degree
Guohua Li

12. IPD Sharing Statement

Learn more about this trial

The Safety and Immunogenicity Research of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination

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