Status:
COMPLETED
Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine
Lead Sponsor:
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Conditions:
Mumps
Eligibility:
All Genders
8-12 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of mumps vaccine in healthy infants aged 8-12months, compared with measles, mumps and rubella combined vaccine, live (MMRV).
Detailed Description
The study is a randomized, double-blind, controlled phase Ⅳ clinical trial. And 920 infants will be assigned to investigational group and controlled group in a 1:1 ratio. The investigational vaccine i...
Eligibility Criteria
Inclusion
- Healthy volunteers between 8 - 12 months old;
- Proven legal identity;
- Written consent of the guardian(s) of the volunteer
Exclusion
- Received mumps vaccine or vaccine containing mumps virus;
- History of mumps;
- Axillary temperature \> 37.4 °C;
- History of allergy to any vaccine or vaccine ingredient;
- History of serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
- Autoimmune disease or immunodeficiency or immunosuppression;
- Congenital malformation, genetic defects, severe malnutrition;
- Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
- Severe chronic diseases (e.g., severe cardiovascular disease, liver and kidney disease beyond the control of drugs, or cancer)
- Severe neurological disorders (epilepsy, seizures or convulsions) or psychosis;
- History of thyroidectomy, absence of spleen, functional absence of spleen, and any condition resulting from absence of spleen or splenectomy;
- Receipt of any of the following products:
- Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- Any live attenuated vaccine within 28 days prior to study entry;
- Any other investigational medicine(s) or vaccine within 30 days prior to study entry;
- Blood product within 3 months prior to study entry;
- Any immunosuppressant, cytotoxic medicine, or oral corticosteroids;
- Any of the acute disease or attack of the chronic disease within 7 days;
- Pregnant in cohabitants or congenital immune diseases;
- Based on the judgment of investigator(s), there was any condition indicating that the subject should be excluded
Key Trial Info
Start Date :
November 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2021
Estimated Enrollment :
920 Patients enrolled
Trial Details
Trial ID
NCT04364399
Start Date
November 18 2020
End Date
April 7 2021
Last Update
August 18 2021
Active Locations (1)
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1
Hezhou Center for Disease Prevention and Control
Hezhou, Guangxi, China, 542699