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

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.

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