Clinical trial NCT01815073: Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine
Official title: A Study to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Japanese Encephalitis
Chickenpox
Lead sponsor: Changchun Keygen Biological Products Co., Ltd.
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial Institute of Biological Products And Materia Medica
First posted: 2013-03-20
Enrollment: 497
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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
* 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

Primary outcomes:
measure: 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.
timeFrame: 35-42 days after vaccination
Secondary outcomes:
measure: Occurrence of adverse events.
timeFrame: within 30 days after each vaccination
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Haizhu District Center for Disease Control and Prevention
state: Guangdong
Study officials:
affiliation: Guangdong Center for Disease Prevention and Control
name: Zheng Huizhen, Master
role: PRINCIPAL_INVESTIGATOR
References: