Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine
NCT ID: NCT02173899
Last Updated: 2014-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
716 participants
INTERVENTIONAL
2014-06-30
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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varicella-1
The second varicella vaccine and 1 year of the interval time between 2 doses
varicella-1
Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day
varicella-3
The second varicella vaccine and 3 years of the interval time between 2 doses
varicella-3
Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day
varicella-5
The second varicella vaccine and 5 years of the interval time between 2 doses
varicella-5
Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day
Interventions
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varicella-1
Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day
varicella-3
Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day
varicella-5
Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day
Eligibility Criteria
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Inclusion Criteria
* Participant is aged ≥ 1 year to ≤ 7 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 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 antiviral 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
1 Year
7 Years
ALL
Yes
Sponsors
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Guangdong Provincial Institute of Biological Products And Materia Medica
OTHER
Changchun Keygen Biological Products Co., Ltd.
OTHER
Responsible Party
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Principal Investigators
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Huizhen Zheng, Master
Role: PRINCIPAL_INVESTIGATOR
Guangdong Center for Disease Prevention and Control
Locations
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Shenzhen Luohu District Center for Disease Control and Prevention
Shenzhen, Guangdong, China
Countries
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Other Identifiers
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NCT02079605
Identifier Type: -
Identifier Source: org_study_id
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