safety and immunogenicity study of live attenuated mumps vaccines in healthy infants

Conditions: Mumps

Summary: the purpose of this study is to evaluate the immunogenicity and safety of a live attenuated mumps vaccine in healthy infants between 8 - 18 months old with a commercialized live attenuated mumps vaccine as the control vaccine.

this study is a randomized, blind, single-center, controlled phase iii clinical trial. the purpose of this study is to evaluate the immunogenicity and safety of a live attenuated mumps vaccine manufactured by sinovac (dalian) vaccine technology co., ltd. the control vaccine is a commercialized live attenuated mumps vaccine manufactured by zhejiang vacn bio-pharmaceutical co. ltd. all participants are healthy infants between 8 - 18 months old, and will be randomly assigned into experimental group or control group in the ratio 1:1.

Eligibility criteria:
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);

Keywords: live attenuated mumps vaccine safety immunogenicity infant