Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine

Sinovac

Status and phase

Completed

Phase 4

Conditions

Mumps

Treatments

Biological: Mumps vaccine

Biological: measles, mumps and rubella combined vaccine, live

Study type

Interventional

Funder types

Industry

Identifiers

NCT04364399

PRO-MUMPS-4006

Details and patient eligibility

About

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).

Full 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 is manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The controlled vaccine is manufactured by Shanghai institute of biological products Co., Ltd.

Enrollment

920 patients

Sex

All

Ages

8 to 12 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy volunteers between 8 - 12 months old;
Proven legal identity;
Written consent of the guardian(s) of the volunteer

Exclusion criteria

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:
1. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
2. Any live attenuated vaccine within 28 days prior to study entry;
3. Any other investigational medicine(s) or vaccine within 30 days prior to study entry;
4. Blood product within 3 months prior to study entry;
5. Any immunosuppressant, cytotoxic medicine, or oral corticosteroids;
6. Any of the acute disease or attack of the chronic disease within 7 days;
7. Pregnant in cohabitants or congenital immune diseases;
8. Based on the judgment of investigator(s), there was any condition indicating that the subject should be excluded