Status:
COMPLETED
Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine
Lead Sponsor:
Changchun Keygen Biological Products Co., Ltd.
Collaborating Sponsors:
Guangdong Provincial Institute of Biological Products And Materia Medica
Conditions:
Japanese Encephalitis
Chickenpox
Eligibility:
All Genders
1-3 years
Phase:
PHASE4
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 ...
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 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
- 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 :
July 1 2013
Estimated Enrollment :
497 Patients enrolled
Trial Details
Trial ID
NCT01815073
Start Date
March 1 2013
End Date
July 1 2013
Last Update
February 24 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Guangzhou Haizhu District Center for Disease Control and Prevention
Guangzhou, Guangdong, China