Safety and Immunogenicity Study of Live Attenuated Mumps Vaccines in Healthy Infants

Exclusion Criteria

• •Axillaty temperature \> 37.0 °C;
• •Any significant abnormity of heart, lung, liver, spleen, lymph nodes, or pharynx;
• •Acute disease or acute stage of chronic disease within 7 days prior to study entry;
• •Prior vaccination with mumps vaccine or with history of mumps infection;
• •History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
• •Receipt of any of the following products:
• •1. Any subunit vaccine or inactivated vaccine within 14 days prior to study entry;
• •2. Any live attenuated vaccine within 28 days prior to study entry;
• •3. Any other investigational medicine(s) within 30 days prior to study entry;
• •4. Blood product (e.g., immunoglobulin) within 3 months prior to study entry;
• •5. Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry;
• •Epilepsy (except febrile seizures), history of seizures or convulsions, or a family history of mental illness;
• •Autoimmune disease or immunodeficiency;
• •Congenital malformation, developmental disorders, or serious chronic diseases (e.g., Down's syndrome, diabetes, sickle cell anemia or neurological disorders);
• •Severe malnutrition;
• •Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities);
• •Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;
• •Participants with the following conditions between day 0 - 28 of this study would be included in the full analysis set (FAS), but would be excluded from the per protocol set (PPS):
• •1. Receipt of any other investigational or unregistered product (drug or vaccine);
• •2. Receipt of immunosuppressant (dosage of corticosteroid ≥ that in 0.5 mg prednisone per kg weight per day) for \> 14 days consecutively, except for inhalant or locally administrated corticosteroid;
• •3. Receipt of immunoglobulin and/or other blood product;
• •4. Newly diagnosed autoimmune disease or immunodeficiency (e.g., HIV infection);