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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04364399
Other study ID # PRO-MUMPS-4006
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 18, 2020
Est. completion date April 7, 2021

Study information

Verified date August 2021
Source Sinovac (Dalian) Vaccine Technology Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 920
Est. completion date April 7, 2021
Est. primary completion date November 18, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Months to 12 Months
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Mumps vaccine
One dose of mumps vaccine: 0.5 ml per dose, mumps live virus not less than 3.7 lg CCID50
measles, mumps and rubella combined vaccine, live
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

Locations

Country Name City State
China Hezhou Center for Disease Prevention and Control Hezhou Guangxi

Sponsors (1)

Lead Sponsor Collaborator
Sinovac (Dalian) Vaccine Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The seroconversion rate of hemagglutination inhibition (HI) antibody Immunogenicity index, One of the standard to evaluate the immunogenicity of experimental vaccine the 30th day after vaccination
Secondary The GMT of HI antibody Immunogenicity index, Another standard to evaluate the immunogenicity of experimental vaccine the 30th day after vaccination
Secondary The incidence of the solicited local and systemic adverse reactions Safety index, The adverse reactions refers to the adverse events which were considered related to the vaccination from day 0 to day 14 after vaccination
Secondary The incidence of the unsolicited adverse events Safety Index from day 0 to day 30 after immunization
Secondary The incidence of the serious adverse events Safety Index from day 0 to day 30 after immunization
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