Mumps
Conditions
Interventions
Trial group A:1 dose of trial vaccine(low dose)
Trial group B:1 dose of trial vaccine(high dose)
Control group :1 dose of positive vaccine
Sponsors
Hubei provincial center for disease control and prevention
Eligibility
Sex/Gender
All
Age
0.7 Years to 2 Years
Inclusion criteria
Inclusion criteria: 1. Healthy infants and young children aged 8 months to 24 months; 2. Subjects who can provide legal identification; 3. Subjects who have no routine vaccination contraindications; 4. Subjects who have no history of mumps and not been vaccinated with vaccine containing mumps virus components; 5. The legal agents of the subject understand this vaccine, have the ability to understand and agree to sign informed consent form, volunteer to participate in the study an sign informed consent form, have the ability to use a thermometer ,scale and fill a diary as required; 6. Subject and their legal agents can comply with the requirements of the clinical trial program, the subject can insist on participate the 1 month visit after the immunization and can be collected the blood an throat swab samples according to the program requirements before and after immunization; 7. The axillary temperature is not higher than 37.0 degree.
Exclusion criteria
Exclusion criteria: 1. Subjects who have received vaccine containing ingredients of mumps virus or have a history of mumps; 2. Subjects have any allergy history of vaccine or drug; 3. Have convulsions, epilepsy, encephalopathy and psychiatric history or family history of epilepsy; 4. Subjects who have a history of thrombocytopenia or other coagulopathy that may cause subcutaneous injection of taboo; 5. Subjects who have received live attenuated vaccine within 14 days before the test vaccine vaccination, or received sub-units or inactivated vaccine within 7 days; 6. Subjects who have received other research drugs within 30 days of test vaccine vaccination; 7. Subjects who received blood products such as immunoglobulin within 1 month of the test vaccine vaccination; 8. Subjects who have received immunosuppressive therapy, cytotoxic drug therapy, inhaled corticosteroid therapy(excluding corticosteroid treatment of allergic rhinitis, and surface corticosteroid therapy for acute non-concurrent dermatitis) over the past 6 months; 9. Subjects who are known or suspected immunological defects, genetic defects( such as broad bean disease), infected with HIV or whose mother are infected with HIV; 10. Subjects who are suffering from congenital malformations or severe chronic diseases(Such as congenital heart disease, Down syndrome, diabetes, sickle cell anemia or neurological disorders, cardiovascular disease, hypertension, bronchitis, pneumonia, asthma, infectious skin diseases, etc.); 11. Subjects with acute and chronic infectious diseases, active infections, or laboratory tests blood, liver and kidney dysfunction; 12. Subjects who are suffering malignant diseases (tumors, etc.), genetic diseases and other diseases that may lead to developmental disorders; 13. Subjects whose spleen and other vital organs were removed for any reason; 14. Other circumstances that the investigators consider are unsuitable for participation in clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemagglutination inhibits antibodies conversion rate;Neutralizing antibody conversion rate; | — |
Countries
China
Contacts
Public ContactBeifang Yang
Hubei provincial center for disease control and prevention
Outcome results
None listed