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Immune Persistence After Inoculated With One-dose Freeze-Dried Live Attenuated Varicella Vaccine in Children Vaccine in Children

Primary Purpose

Chickenpox

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Live Attenuated Varicella Vaccine
Sponsored by
Changchun Changsheng Life Science and Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chickenpox

Eligibility Criteria

1 Year - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participant are healthy children aged 1-6 years, who has inquired for medical history and physical examination, and met the requirement of the vaccine trial
  • Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
  • Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
  • Body temperature ≤37℃

Exclusion Criteria:

  • Participant with previous history of chickenpox or zoster
  • Receipt of varicella vaccine
  • Reported the family history of allergies, convulsions, epilepsy and mental illness
  • Known allergy to any constituent of the vaccine
  • Known serve illness, in a fever, acute infection and chronic disease activity
  • Receipt of steroid
  • Reported the history of thrombocytopenia or other coagulation disorders, which may cause
  • Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
  • Known congenital malformation, developmental disorders and severe chronic disease (e.g. Down's syndrome, diabetes, sickle cell anemia and neurologic disorders)
  • Known dermatopathy with allergy, herpes, fester, and fungal infection
  • Receipt of whole blood, blood plasma or immunoglobulin in the 3 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
  • Participant with fever(temperature≥ 38℃) in the days
  • Any condition, which, in the opinion of the investigator, would pose a health risk to the subject

Sites / Locations

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

Outcomes

Primary Outcome Measures

Immune protective effect and persistence after inoculated with live attenuated varicella vaccine
Clinical subjects are drawn 3ml's vein blood,respectively before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine. FAMA methods are used to test antibody rate of pox virus.

Secondary Outcome Measures

Breakthrough rate, duration and severity of varicella in vaccinated children
Occurrence of adverse events

Full Information

First Posted
October 24, 2013
Last Updated
March 25, 2014
Sponsor
Changchun Changsheng Life Science and Technology Co., Ltd.
Collaborators
Guangdong Provincial Institute of Biological Products And Materia Medica
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1. Study Identification

Unique Protocol Identification Number
NCT01982409
Brief Title
Immune Persistence After Inoculated With One-dose Freeze-Dried Live Attenuated Varicella Vaccine in Children Vaccine in Children
Official Title
A Study of Immune Persistence After Inoculated With One-dose Freeze-dried Live Attenuated Varicella Vaccine in Children Aged 1-6 Years
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun Changsheng Life Science and Technology 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 persistence of protection, duration of protection, safety and breakthrough infection rates afforded by live attenuated varicella vaccine in children over a 5-year period.

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
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Live Attenuated Varicella Vaccine
Arm Type
Experimental
Arm Description
use the 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
Immune protective effect and persistence after inoculated with live attenuated varicella vaccine
Description
Clinical subjects are drawn 3ml's vein blood,respectively before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine. FAMA methods are used to test antibody rate of pox virus.
Time Frame
Before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine
Secondary Outcome Measure Information:
Title
Breakthrough rate, duration and severity of varicella in vaccinated children
Time Frame
5 years period
Title
Occurrence of adverse events
Time Frame
Up to 4 weeks after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant are healthy children aged 1-6 years, who has inquired for medical history and physical examination, and met the requirement of the vaccine trial Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures Body temperature ≤37℃ Exclusion Criteria: Participant with previous history of chickenpox or zoster Receipt of varicella vaccine Reported the family history of allergies, convulsions, epilepsy and mental illness Known allergy to any constituent of the vaccine Known serve illness, in a fever, acute infection and chronic disease activity Receipt of steroid Reported the history of thrombocytopenia or other coagulation disorders, which may cause Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth Known congenital malformation, developmental disorders and severe chronic disease (e.g. Down's syndrome, diabetes, sickle cell anemia and neurologic disorders) Known dermatopathy with allergy, herpes, fester, and fungal infection Receipt of whole blood, blood plasma or immunoglobulin in the 3 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 Participant with fever(temperature≥ 38℃) in the days Any condition, which, in the opinion of the investigator, would pose a health risk to the subject
Facility Information:
Facility Name
Maoming Center for Disease Control and Prevention
City
Maoming
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Learn more about this trial

Immune Persistence After Inoculated With One-dose Freeze-Dried Live Attenuated Varicella Vaccine in Children Vaccine in Children

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