Japanese Encephalitis Clinical Trial
Official title:
A Study to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine
| Verified date | February 2014 |
| Source | Changchun Keygen Biological Products Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 497 |
| Est. completion date | July 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 1 Year to 3 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Guangzhou Haizhu District Center for Disease Control and Prevention | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Changchun Keygen Biological Products Co., Ltd. | Guangdong Provincial Institute of Biological Products And Materia Medica |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 35-42 days after vaccination | ||
| Secondary | Occurrence of adverse events. | within 30 days after each vaccination |
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