Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine

Randomized, Double-blind, Controlled Phase Ⅳ Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine in Healthy Infants Aged 8 ~12 Months.

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).

Study Overview

• Status: Completed
• Conditions: Mumps
• Intervention / Treatment: Biological: Mumps vaccine; Biological: measles, mumps and rubella combined vaccine, live

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 Type: Interventional
• Enrollment (Actual): 920
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Hezhou, Guangxi, China, 542699
      • Hezhou Center for Disease Prevention and Control

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The GMT of HI antibody	Immunogenicity index, Another standard to evaluate the immunogenicity of experimental vaccine	the 30th day after vaccination
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
The incidence of the unsolicited adverse events	Safety Index	from day 0 to day 30 after immunization
The incidence of the serious adverse events	Safety Index	from day 0 to day 30 after immunization

Collaborators and Investigators

• Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
• Investigators: Principal Investigator: Lirong Huang, Bachelor, Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2020
• Primary Completion (Actual): November 18, 2020
• Study Completion (Actual): April 7, 2021

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: infants; Mumps; Mumps vaccine; measles, mumps and rubella combined vaccine, live
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Stomatognathic Diseases; Mouth Diseases; Paramyxoviridae Infections; Mononegavirales Infections; Salivary Gland Diseases; Rubulavirus Infections; Parotitis; Parotid Diseases; Mumps; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: PRO-MUMPS-4006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No