Prevention of mumps
Conditions
Interventions
Group A (adult low-dose group):Group A: Control: placebo = 3: 1: 1, 1 dose (0.5ml)
Group B (juvenile low-dose group):Group B: Control: placebo = 3: 1: 1, 1 dose (0.5 ml)
Group C (adult medium dose group):Group C: Control: placebo = 3: 1: 1, 1 dose (0.5 ml)
Group D (juvenile medium-dose group):Group D: Control: placebo = 3: 1: 1, 1 dose (0.5 ml)
Group E (adult high-dose group):Group E: Control: placebo = 3: 1: 1, 1 dose (0.5 ml)
Group F (juvenile high-dose group):Group F: Control: placebo = 3: 1: 1, 1 dose (0.5 ml)
Sponsors
Hubei Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
6 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers aged 6-59 (over 6 years old and under 60 years old) can comply with the requirements of the clinical trial protocol and complete the visit plan for the entire observation period of the clinical trial; 2. The subject or legal guardian has full understanding and cognitive ability, and signs the informed consent form; 3. The subject or legal guardian can complete the completion of the diary card; 4. Women of childbearing age (menarche to menopause) with a negative urine pregnancy test, and can guarantee contraception within 2 months after the first vaccination in this clinical trial; 5. Underarm body temperature <= 37.0 °C.
Exclusion criteria
Exclusion criteria: 1. Have a history of mumps disease; 2. Previous vaccination has had serious adverse reactions, such as allergies, urticaria, dyspnea, angioedema or abdominal pain; Those known to be allergic to any of the ingredients contained in the vaccine, including excipients; 3. Those suffering from uncontrolled epilepsy or other progressive neurological diseases; 4. Have an autoimmune disease or immunodeficiency; 5. History of thyroidectomy, or requiring treatment due to thyroid disease within the past 12 months; 6. Asplenia, functional asplenia, and asplenectomy caused by any condition, Guillain-Barre syndrome; 7. Malignant tumors, active or treated tumors without clear cure, or potential to recur during the study; 8. Have immunosuppressant therapy, cytotoxic therapy, inhaled corticosteroids in the past 6 months (excluding corticosteroid spray therapy for allergic rhinitis, superficial corticosteroid therapy for acute non-complicated dermatitis); 9. Those who plan to use immunoglobulin or any blood product during the study or within 3 months before the first immunization; 10. Abnormal coagulation function (such as coagulation factor deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorders diagnosed by the doctor; 11. Ongoing prevention or treatment of anti-TB; 12. Those who have received other live attenuated vaccines within 4 weeks before vaccination, or those who have received other subunits or inactivated vaccines within 2 weeks before the first vaccination; 13. Those suffering from acute diseases, serious chronic diseases, acute exacerbation of chronic diseases and fever; 14. Past or present mental illness due to psychological conditions that cannot comply with the requirements of the study; 15. Women who are breastfeeding, pregnant or planning to become pregnant within 2 months after the first vaccination in the test; 16. Subject has any other factors that are not suitable for participation in clinical trials in the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| security; | — |
Countries
China
Contacts
Public ContactXianfeng Zhang
Hubei Provincial Center for Disease Control and Prevention
Outcome results
None listed