Title
Immunogenicity and Safety Study of 2 Doses of Live Attenuated Varicella Vaccine
A Study to Evaluate the Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine
Phase
Phase 4Lead Sponsor
Changchun Keygen Biological Products Co., Ltd.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
ChickenpoxIntervention/Treatment
live attenuated varicella vaccine ...Study Participants
368The 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.
use the left arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
Inclusion Criteria: 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 Criteria: 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