Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine
Primary Purpose
Japanese Encephalitis, Chickenpox
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine
Live Attenuated Varicella Vaccine
live attenuated JE vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Japanese Encephalitis
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 previous history of chickenpox, zoster and epidemic encephalitis B
- 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
- Guangzhou Haizhu District Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine
Live Attenuated Varicella Vaccine
Live Attenuated JE 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
use the right arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
use the right 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, live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.
Secondary Outcome Measures
Occurrence of adverse events.
Full Information
NCT ID
NCT01815073
First Posted
March 18, 2013
Last Updated
February 20, 2014
Sponsor
Changchun Keygen Biological Products Co., Ltd.
Collaborators
Guangdong Provincial Institute of Biological Products And Materia Medica
1. Study Identification
Unique Protocol Identification Number
NCT01815073
Brief Title
Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine
Official Title
A Study to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 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 and seroconversion rate, geometric mean titres (GMTs) of live attenuated varicella vaccine,live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Japanese Encephalitis, Chickenpox
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
497 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Live Attenuated Varicella Vaccine + Live Attenuated JE 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
Arm Title
Live Attenuated Varicella Vaccine
Arm Type
Experimental
Arm Description
use the right arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
Arm Title
Live Attenuated JE Vaccine
Arm Type
Experimental
Arm Description
use the right 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 + Live Attenuated JE Vaccine
Intervention Type
Biological
Intervention Name(s)
Live Attenuated Varicella Vaccine
Intervention Type
Biological
Intervention Name(s)
live attenuated JE vaccine
Primary Outcome Measure Information:
Title
Seroconversion rate and GMTs for live attenuated varicella vaccine, live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.
Time Frame
35-42 days after vaccination
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 previous history of chickenpox, zoster and epidemic encephalitis B
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
Zheng Huizhen, Master
Organizational Affiliation
Guangdong Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Haizhu District Center for Disease Control and Prevention
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine
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