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Immunogenicity and Safety Study of 2 Doses of Live Attenuated Varicella Vaccine

Primary Purpose

Chickenpox

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Live Attenuated Varicella Vaccine
Sponsored by
Changchun Keygen Biological Products Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chickenpox

Eligibility Criteria

1 Year - 3 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
  • Participant is aged ≥ 1 year to ≤ 3 years
  • Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster
  • Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
  • Body temperature ≤ 37.5℃

Exclusion Criteria:

  • Known allergy to any constituent of the vaccine
  • Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever
  • Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
  • Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
  • Failed to the Expanded Programme on Immunization(EPI)
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination
  • Plan to receive any vaccine in the 4 weeks following the trial vaccination
  • Known bleeding disorder
  • Receipt of whole blood, blood plasma or immunoglobulin in the 5 months preceding the trial vaccination
  • Reported the history of acute illness had need systemic antibiotics or anti-viral treatment of infections in the 7 days preceding the trial vaccination
  • An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial
  • Participation in any other interventional clinical trial
  • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine

Sites / Locations

  • Xinxing Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Live Attenuated Varicella Vaccine

Arm Description

use the left arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection

Outcomes

Primary Outcome Measures

Seroconversion rate and GMTs for live attenuated varicella vaccine

Secondary Outcome Measures

Occurrence of adverse events

Full Information

First Posted
March 4, 2013
Last Updated
October 14, 2013
Sponsor
Changchun Keygen Biological Products Co., Ltd.
Collaborators
Guangdong Provincial Institute of Biological Products And Materia Medica
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1. Study Identification

Unique Protocol Identification Number
NCT01817270
Brief Title
Immunogenicity and Safety Study of 2 Doses of Live Attenuated Varicella Vaccine
Official Title
A Study to Evaluate the Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun Keygen Biological Products Co., Ltd.
Collaborators
Guangdong Provincial Institute of Biological Products And Materia Medica

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to observe the occurrence of adverse events, seroconversion rate and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
368 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Live Attenuated Varicella Vaccine
Arm Type
Experimental
Arm Description
use the left arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
Intervention Type
Biological
Intervention Name(s)
Live Attenuated Varicella Vaccine
Primary Outcome Measure Information:
Title
Seroconversion rate and GMTs for live attenuated varicella vaccine
Time Frame
35-42 days after the first and second doses
Secondary Outcome Measure Information:
Title
Occurrence of adverse events
Time Frame
within 30 days after each vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent Participant is aged ≥ 1 year to ≤ 3 years Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures Body temperature ≤ 37.5℃ Exclusion Criteria: Known allergy to any constituent of the vaccine Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction Failed to the Expanded Programme on Immunization(EPI) Receipt of any vaccine in the 4 weeks preceding the trial vaccination Plan to receive any vaccine in the 4 weeks following the trial vaccination Known bleeding disorder Receipt of whole blood, blood plasma or immunoglobulin in the 5 months preceding the trial vaccination Reported the history of acute illness had need systemic antibiotics or anti-viral treatment of infections in the 7 days preceding the trial vaccination An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial Participation in any other interventional clinical trial Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huizhen Zheng, Master
Organizational Affiliation
Guangdong Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinxing Center for Disease Control and Prevention
City
Yunfu
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity and Safety Study of 2 Doses of Live Attenuated Varicella Vaccine

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