Chickenpox Clinical Trial
Official title:
Evaluation of Safety and Immunogenicity Receiving Live Attenuated Vaccine Against Varicella Without Gelatin
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.
Status | Completed |
Enrollment | 1200 |
Est. completion date | January 2012 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 1 Year to 12 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Jiuyuan Center for Disease Control and Prevention | Baotou | Inner Mongolia |
China | Chaoyang District Center for Disease Control and Prevention | Beijing | Beijing |
China | Sanhe Center for Disease Control and Prevention | Langfang | Hebei |
Lead Sponsor | Collaborator |
---|---|
Beijing Center for Disease Control and Prevention |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 8 months | No |
Secondary | To evaluate the safety of live attenuated varicella vaccine | The incidence of adverse events was analyzed statistically. | 4 months | Yes |
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