Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine

Sponsor

Sinovac (Dalian) Vaccine Technology Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04364399

Collaborator

(none)

920

Enrollment

Location

Arms

4.6

Actual Duration (Months)

200

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Mumps	Biological: Mumps vaccine Biological: measles, mumps and rubella combined vaccine, live	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

920 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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.

Actual Study Start Date :

Nov 18, 2020

Actual Primary Completion Date :

Nov 18, 2020

Actual Study Completion Date :

Apr 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group Mumps vaccine, one dose	Biological: Mumps vaccine One dose of mumps vaccine: 0.5 ml per dose, mumps live virus not less than 3.7 lg CCID50
Active Comparator: Control group measles, mumps and rubella combined vaccine, live, one dose	Biological: 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

Arm

Intervention/Treatment

Experimental: Experimental group

Mumps vaccine, one dose

Biological: Mumps vaccine

One dose of mumps vaccine: 0.5 ml per dose, mumps live virus not less than 3.7 lg CCID50

Active Comparator: Control group

measles, mumps and rubella combined vaccine, live, one dose

Biological: 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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Months to 12 Months

Sexes Eligible for Study:

All

Accepts 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:

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