Status:
COMPLETED
Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine（Hecolin®）
Lead Sponsor:
Jun Zhang
Collaborating Sponsors:
Xiamen Innovax Biotech Co., Ltd
Xiamen Center for Disease Control and Prevention
Conditions:
Hepatitis E
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the safety and immunogenicity of the recombinant hepatitis E vaccine in people older than 65 years, and evaluate the efficacy of hepatitis E vaccine in this p...
Eligibility Criteria
Inclusion
- Healthy people aged over 16 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.
- Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
- Subjects will reside in the study region in the next 7 months.
- Free of history of hepatitis E.
- Can comply with the request of study.
- Axillary temperature is below 37 degree centigrade.
Exclusion
- For dose 1:
- receiving other vaccine or immunoglobulin within two weeks;
- Having serious allergic history to vaccine and medicine
- Eclampsia, epilepsy, encephalopathy and history of mental disease or family;
- Thrombocytopenia or other disturbance of blood coagulation which would lead to muscle injection taboo;
- Fixed or suspected deficiency of immunologic function, containing immunosuppressant treatment, genetic defect, HIV or other factors;
- Congenital malformation, eccyliosis or severe chronic disease;
- Fixed or suspected other disease including fever, active infection, liver and kidney disease, angiocardiopathy, malignancy, acute and chronic disease;
- joining other clinical study undergoing;
- women pregnant or in lactation.
- For dose 2 or 3:
- Severe allergy for dose 1 or 2;
- Severe adverse reaction associated with last vaccination;
- New occurrence of symptoms meet dose 1 exclusion criteria after the first dose.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2015
Estimated Enrollment :
601 Patients enrolled
Trial Details
Trial ID
NCT02189603
Start Date
June 1 2014
End Date
December 7 2015
Last Update
August 17 2018
Active Locations (1)
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1
Center for disease control and prevention in Xiamen haicang district
Xiamen, Fujian, China, 361000