Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin
NCT ID: NCT01684072
Last Updated: 2012-09-12
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
1200 participants
INTERVENTIONAL
2011-01-31
2012-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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vaccine without gelatin
use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
vaccine without gelatin
use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
vaccine with gelatin
use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
vaccine with gelatin
use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
vaccine without gelatin
use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
vaccine with gelatin
use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
Interventions
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vaccine without gelatin
use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
vaccine with gelatin
use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
12 Years
ALL
Yes
Sponsors
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Beijing Center for Disease Control and Prevention
OTHER_GOV
Responsible Party
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Principal Investigators
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Nianmin Shi
Role: STUDY_CHAIR
Beijing Chaoyang District Center for Disease Control and Prevention
Locations
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Chaoyang District Center for Disease Control and Prevention
Beijing, Beijing Municipality, China
Sanhe Center for Disease Control and Prevention
Langfang, Hebei, China
Jiuyuan Center for Disease Control and Prevention
Baotou, Inner Mongolia, China
Countries
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Other Identifiers
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BJCDPC-2
Identifier Type: -
Identifier Source: org_study_id