Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine（Hecolin®）
Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine（Hecolin®）
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 population.
Inclusion Criteria:

 -  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 Criteria:

 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.