Immunogenicity and Safety Study of 2 Doses of Live Attenuated Varicella Vaccine

Changchun Keygen Biological Products

Status and phase

Completed

Phase 4

Conditions

Chickenpox

Treatments

Biological: Live Attenuated Varicella Vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT01817270

NCT02038506

Details and patient eligibility

About

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.

Enrollment

368 patients

Sex

All

Ages

1 to 3 years old

Volunteers

Accepts Healthy Volunteers

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