Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine

Mumps Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04364399
• Other study ID #: PRO-MUMPS-4006
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Mumps

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