Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine
Primary Purpose
Mumps
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Mumps vaccine
measles, mumps and rubella combined vaccine, live
Sponsored by
About this trial
This is an interventional prevention trial for Mumps focused on measuring Mumps, Mumps vaccine, measles, mumps and rubella combined vaccine, live, infants
Eligibility Criteria
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:
- Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- Any live attenuated vaccine within 28 days prior to study entry;
- Any other investigational medicine(s) or vaccine within 30 days prior to study entry;
- Blood product within 3 months prior to study entry;
- Any immunosuppressant, cytotoxic medicine, or oral corticosteroids;
- Any of the acute disease or attack of the chronic disease within 7 days;
- Pregnant in cohabitants or congenital immune diseases;
- Based on the judgment of investigator(s), there was any condition indicating that the subject should be excluded
Sites / Locations
- Hezhou Center for Disease Prevention and Control
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
Mumps vaccine, one dose
measles, mumps and rubella combined vaccine, live, one dose
Outcomes
Primary Outcome Measures
The seroconversion rate of hemagglutination inhibition (HI) antibody
Immunogenicity index, One of the standard to evaluate the immunogenicity of experimental vaccine
Secondary Outcome Measures
The GMT of HI antibody
Immunogenicity index, Another standard to evaluate the immunogenicity of experimental vaccine
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
The incidence of the unsolicited adverse events
Safety Index
The incidence of the serious adverse events
Safety Index
Full Information
NCT ID
NCT04364399
First Posted
April 7, 2020
Last Updated
August 16, 2021
Sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04364399
Brief Title
Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine
Official Title
Randomized, Double-blind, Controlled Phase Ⅳ Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine in Healthy Infants Aged 8 ~12 Months.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
November 18, 2020 (Actual)
Study Completion Date
April 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mumps
Keywords
Mumps, Mumps vaccine, measles, mumps and rubella combined vaccine, live, infants
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
920 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Mumps vaccine, one dose
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
measles, mumps and rubella combined vaccine, live, one dose
Intervention Type
Biological
Intervention Name(s)
Mumps vaccine
Intervention Description
One dose of mumps vaccine: 0.5 ml per dose, mumps live virus not less than 3.7 lg CCID50
Intervention Type
Biological
Intervention Name(s)
measles, mumps and rubella combined vaccine, live
Intervention Description
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
Primary Outcome Measure Information:
Title
The seroconversion rate of hemagglutination inhibition (HI) antibody
Description
Immunogenicity index, One of the standard to evaluate the immunogenicity of experimental vaccine
Time Frame
the 30th day after vaccination
Secondary Outcome Measure Information:
Title
The GMT of HI antibody
Description
Immunogenicity index, Another standard to evaluate the immunogenicity of experimental vaccine
Time Frame
the 30th day after vaccination
Title
The incidence of the solicited local and systemic adverse reactions
Description
Safety index, The adverse reactions refers to the adverse events which were considered related to the vaccination
Time Frame
from day 0 to day 14 after vaccination
Title
The incidence of the unsolicited adverse events
Description
Safety Index
Time Frame
from day 0 to day 30 after immunization
Title
The incidence of the serious adverse events
Description
Safety Index
Time Frame
from day 0 to day 30 after immunization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
Any live attenuated vaccine within 28 days prior to study entry;
Any other investigational medicine(s) or vaccine within 30 days prior to study entry;
Blood product within 3 months prior to study entry;
Any immunosuppressant, cytotoxic medicine, or oral corticosteroids;
Any of the acute disease or attack of the chronic disease within 7 days;
Pregnant in cohabitants or congenital immune diseases;
Based on the judgment of investigator(s), there was any condition indicating that the subject should be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lirong Huang, Bachelor
Organizational Affiliation
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hezhou Center for Disease Prevention and Control
City
Hezhou
State/Province
Guangxi
ZIP/Postal Code
542699
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine
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