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

This is an interventional prevention trial for Mumps focused on measuring live attenuated mumps vaccine, safety, immunogenicity, infant Read More

Inclusion Criteria:

• Healthy volunteer between 8 - 18 months old;
• Proven legal identity;
• Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study;
• Complying with the requirement of the study protocol;

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);