A Study to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine

Changchun Keygen Biological Products Co., Ltd.1 site in 1 country497 target enrollmentMarch 2013

ConditionsJapanese Encephalitis Chickenpox

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Japanese Encephalitis
Sponsor: Changchun Keygen Biological Products Co., Ltd.
Enrollment: 497
Locations: 1
Primary Endpoint: Seroconversion rate and GMTs for live attenuated varicella vaccine, live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.
Status: Completed
Last Updated: 12 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 and seroconversion rate, geometric mean titres (GMTs) of live attenuated varicella vaccine，live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

July 2013

Last Updated

12 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 ≤ 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 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

Outcomes

Primary Outcomes

Seroconversion rate and GMTs for live attenuated varicella vaccine, live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.

Time Frame: 35-42 days after vaccination