Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine

NCT ID: NCT04364399

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 920 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-18
• Study Completion Date: 2021-04-07

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.

Conditions

Mumps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

Mumps vaccine, one dose

Group Type: EXPERIMENTAL

Mumps vaccine

Intervention Type: BIOLOGICAL

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

Control group

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

Group Type: ACTIVE_COMPARATOR

measles, mumps and rubella combined vaccine, live

Intervention Type: BIOLOGICAL

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

Interventions

Mumps vaccine

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

Intervention Type: 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

Intervention Type: BIOLOGICAL

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:

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

• Minimum Eligible Age: 8 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinovac (Dalian) Vaccine Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lirong Huang, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

Locations

Hezhou Center for Disease Prevention and Control

Hezhou, Guangxi, China

Countries

China

Other Identifiers

PRO-MUMPS-4006

Identifier Type: -

Identifier Source: org_study_id