Mumps
Conditions
Keywords
Mumps, Mumps vaccine, measles, mumps and rubella combined vaccine, live, infants
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 is manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The controlled vaccine is manufactured by Shanghai institute of biological products Co., Ltd.
Interventions
BIOLOGICALMumps vaccine
One dose of mumps vaccine: 0.5 ml per dose, mumps live virus not less than 3.7 lg CCID50
One dose of measles, mumps and rubella combined vaccine, live: 0.5 ml per dose, mumps live virus not less than 4.3 lg CCID50
Sponsors
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Months to 12 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The seroconversion rate of hemagglutination inhibition (HI) antibody | the 30th day after vaccination | Immunogenicity index, One of the standard to evaluate the immunogenicity of experimental vaccine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The GMT of HI antibody | the 30th day after vaccination | Immunogenicity index, Another standard to evaluate the immunogenicity of experimental vaccine |
| The incidence of the solicited local and systemic adverse reactions | from day 0 to day 14 after vaccination | Safety index, The adverse reactions refers to the adverse events which were considered related to the vaccination |
| The incidence of the unsolicited adverse events | from day 0 to day 30 after immunization | Safety Index |
| The incidence of the serious adverse events | from day 0 to day 30 after immunization | Safety Index |
Countries
China
Outcome results
None listed