Status:
COMPLETED
Immunogenicity and Safety Study of 2 Doses of Live Attenuated Varicella Vaccine
Lead Sponsor:
Changchun Keygen Biological Products Co., Ltd.
Collaborating Sponsors:
Guangdong Provincial Institute of Biological Products And Materia Medica
Conditions:
Chickenpox
Eligibility:
All Genders
1-3 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to observe the occurrence of adverse events, seroconversion rate and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.
Eligibility Criteria
Inclusion
- 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 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT01817270
Start Date
March 1 2013
End Date
August 1 2013
Last Update
October 16 2013
Active Locations (1)
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1
Xinxing Center for Disease Control and Prevention
Yunfu, Guangdong, China