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Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin

Primary Purpose

Chickenpox, Zoster

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
vaccine without gelatin
vaccine with gelatin
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 Chickenpox focused on measuring varicella vaccine, gelatin

Eligibility Criteria

1 Year - 12 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 considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months
  • Participant is aged ≥ 1 year to ≤ 12 years
  • Body temperature ≤ 37.0℃
  • Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster

Exclusion Criteria:

  • Known allergy to any constituent of the vaccine
  • Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
  • Known bleeding disorder
  • Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
  • Participation in any other interventional clinical trial
  • An acute illness with or without fever (temperature > 37.0℃) in the latest week preceding enrollment in the trial
  • Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study
  • Reported clearly the infection of the upper respiratory tract with 6 months
  • Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor
  • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine

Sites / Locations

  • Chaoyang District Center for Disease Control and Prevention
  • Sanhe Center for Disease Control and Prevention
  • Jiuyuan Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

vaccine without gelatin

vaccine with gelatin

Arm Description

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

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

Outcomes

Primary Outcome Measures

To evaluate the immunogenicity of evaluated vaccine
The immunologic equivalence of 4weeks after vaccination of influenza virus vaccine was measured in terms of the level of antibody.

Secondary Outcome Measures

To evaluate the safety of live attenuated varicella vaccine
The incidence of adverse events was analyzed statistically.

Full Information

First Posted
September 9, 2012
Last Updated
September 9, 2012
Sponsor
Beijing Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01684072
Brief Title
Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin
Official Title
Evaluation of Safety and Immunogenicity Receiving Live Attenuated Vaccine Against Varicella Without Gelatin
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
January 2012 (Actual)

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
The purpose of this study is to observe the occurrence of adverse reaction and antibody positive rate, the elevated level of antibody，Geometric mean titer (GMT) between groups of live attenuated varicella vaccine without gelatin.
Detailed Description
Observational Objectives: To describe the safety of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday. To describe the immunogenicity of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chickenpox, Zoster
Keywords
varicella vaccine, gelatin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vaccine without gelatin
Arm Type
Experimental
Arm Description
use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
Arm Title
vaccine with gelatin
Arm Type
Active Comparator
Arm Description
use the upper 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)
vaccine without gelatin
Intervention Description
use the upper 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)
vaccine with gelatin
Intervention Description
use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
Primary Outcome Measure Information:
Title
To evaluate the immunogenicity of evaluated vaccine
Description
The immunologic equivalence of 4weeks after vaccination of influenza virus vaccine was measured in terms of the level of antibody.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
To evaluate the safety of live attenuated varicella vaccine
Description
The incidence of adverse events was analyzed statistically.
Time Frame
4 months

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: Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months Participant is aged ≥ 1 year to ≤ 12 years Body temperature ≤ 37.0℃ Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster Exclusion Criteria: Known allergy to any constituent of the vaccine Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction Known bleeding disorder Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth Participation in any other interventional clinical trial An acute illness with or without fever (temperature > 37.0℃) in the latest week preceding enrollment in the trial Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study Reported clearly the infection of the upper respiratory tract with 6 months Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor 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
Nianmin Shi
Organizational Affiliation
Beijing Chaoyang District Center for Disease Control and Prevention
Official's Role
Study Chair
Facility Information:
Facility Name
Chaoyang District Center for Disease Control and Prevention
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Sanhe Center for Disease Control and Prevention
City
Langfang
State/Province
Hebei
Country
China
Facility Name
Jiuyuan Center for Disease Control and Prevention
City
Baotou
State/Province
Inner Mongolia
Country
China

12. IPD Sharing Statement

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Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin

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