A Study to Evaluate the Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine

Changchun Keygen Biological Products Co., Ltd.1 site in 1 country716 target enrollmentJune 2014

ConditionsVaricella

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Varicella
Sponsor: Changchun Keygen Biological Products Co., Ltd.
Enrollment: 716
Locations: 1
Primary Endpoint: Seroconversion rate and GMTs for live attenuated varicella vaccine
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2014

End Date

August 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Changchun Keygen Biological Products Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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 ≤ 7 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 antiviral treatment of infections in the 7 days preceding the trial vaccination