Phase II of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants

This is an interventional prevention trial for Epidemic Parotitis,Mumps focused on measuring Attenuated Mumps Vaccine(F-genotype，Human Diploid Cell, KMB-17), safety, immunogenecity Read More

Inclusion Criteria:

• Healthy males and females (from 8 months to 24 months old) as determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator.
• Provided legal identification for the sake of recruitment.
• Without the routine corticosteroids of vaccination .
• Never has gone down with mumps or taken a vaccine contain mumps.
• parent(s)/legal guardian(s) are able to understand and sign informed consents and be able to read a thermometer and dividing ruler .At the same time,the parent(s)/legal guardian(s)should have the ability and objective to comply with the requirements of the protocol.
• Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions; can persist for a 1-month visit and receive blood sample and throat swab collection according to program requirements.
• Axillary temperature ≤37℃.

Exclusion Criteria:

• Subject who has a medical history of Mumps or taken a vaccine contain mumps.
• Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
• Convulsant,encephalopathy,psychosis or family histoty of epileptics.
• Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder,it will couse the contraindication of subcutaneous injection
• Any prior administration of attenuated live vaccine in last 15 days;Any prior administration of subunit or inactivated vaccines in last 7 days
• Any prior administration of other research medicines in last 30 days.
• Any prior administration of blood products(immunoglobulin etc.) in last 1 month;Any prior administration of immunodepressant ，cytotoxic drugs or corticosteroids in last 6 months(except the corticosteroids spray can treat irritability rhinitis orcorticosteroids to cure noncomplication acute dermatitis ).
• Any confirmed or suspected autoimmune disease or immune deficiency diseases(like favism or other diseases etc. ), including human immunodeficiency virus (HIV) infection.
• Suffering from congenital deformity or serious chronic disease(congenital heart disease，Down's syndrome,diabetes,sickle cell anemia,nervous illness,cardiocardiopathy,hypertension,bronchitis,pneumonia,asthma,infectious skin diseases)
• Acute or chronic infectious disease,active infectious;Laboratory test show Routine blood abnormal or hepatorenal dysfunction.
• Malignant disease(like cancer)，heredopathia or other disease that will cuase eccyliosis.The spleen or other important organ has been removed for any reason.
• Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.