mumps
Conditions
Interventions
Trial vaccine in the medium-dose group:Inoculated with live attenuated genetically recombinant mumps vaccine (F genotype), medium dose, containing live attenuated mumps virus of F genotype 4.8±0.25 lg
High-dose group of trial vaccines:Inoculated with genetically recombinant live attenuated mumps vaccine (F genotype), high dose, containing F genotype live attenuated mumps virus 5.6±0.25 lgCCID50
Control group of similar products:Vaccination with control vaccine: live attenuated mumps vaccine
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 clinical trial protocol requirements to complete the visit schedule for the entire observation period of the clinical trial; (2) The subject himself or legal guardian has full understanding and cognitive ability, and signs the informed consent form; (3) The subject or legal guardian can complete the diary card; (4) Females of childbearing age (from menarche to menopause) who have a negative urine pregnancy test and can ensure contraception within 2 months after the first dose of the vaccine in this clinical trial; (5) Armpit body temperature = 37.0°C.
Exclusion criteria
Exclusion criteria: (1) Have a history of mumps disease; (2) Those who have had serious adverse reactions to previous vaccination, such as allergies, urticaria, dyspnea, angioedema or abdominal pain, and those who are known to be allergic to any of the ingredients contained in the vaccine, including excipients; (3) Those with uncontrolled epilepsy or other progressive neurological diseases; (4) Have an autoimmune disease or immunodeficiency; (5) History of thyroidectomy, or need for treatment due to thyroid disease within the past 12 months; (6) asplenia, functional asplenia, and asplenia or splenectomy caused by any condition, Guillain-Barré syndrome; (7) Malignant tumors, active or treated tumors that have not been clearly cured, or are likely to recur during the study period; (8) There have been immunosuppressive therapy, cytotoxic therapy, and inhaled corticosteroids in the past 6 months (excluding the treatment of allergic rhinitis with corticosteroid spray, and the treatment of acute non concurrent dermatitis with topical corticosteroids); (9) Individuals who plan to use or have used immunoglobulin or any blood product within 3 months prior to their first immunization during the study period; (10) Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or obvious bruising or coagulation disorders diagnosed by doctors; (11) Currently undergoing anti TB prevention or treatment; (12) Individuals who have received other attenuated live vaccines within 4 weeks prior to vaccination, or who have received other subunits or inactivated vaccines within 2 weeks prior to their first vaccination; (13) Those suffering from acute diseases, severe chronic diseases, acute attacks of chronic diseases and fever; (14) Past or present psychiatric illness due to psychological inability to comply with the requirements of the study; (15) Women who are breastfeeding, pregnant, or planning to become pregnant within 2 months after the first dose of vaccination in the trial; (16) According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum anti F genotype mumps virus neutralizing antibody positivity conversion rate in the experimental group and control group on the 14th and 30th day after immunization;The incidence of adverse reactions within 30 days after the immunization of subjects in the experimental group and the control group; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of solicited adverse events within days 0 to 14 days after the trial group and the control group subjects;Overall incidence of adverse events from day 0 to 30 days after free treatment for participants in the experimental and control groups;The incidence of non-solicited adverse events within days 0 to 30 days after the trial and control groups;Serum anti F genotype mumps virus neutralizing antibody GMT on the 14th and 30th day after immunization of subjects in the experimental and control groups;The incidence of serious adverse events within 6 months after immunization of subjects in the experimental group and the control group;Subject detoxification rate and duration on the 3rd, 14th, and 6th months before and after immunization; | — |
Countries
China
Contacts
Public ContactXianfeng Zhang
Hubei Provincial Center for Disease Control and Prevention
Outcome results
None listed