Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine

Phase 4

Completed

• Conditions: Mumps

• Registration Number: NCT04364399
• Lead Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-28
• Study Start: 2020-11-18
• Primary Completion: 2020-11-18
• Study Completion: 2021-04-07
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 920

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The incidence of the unsolicited adverse events	from day 0 to day 30 after immunization	Safety Index
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 serious adverse events	from day 0 to day 30 after immunization	Safety Index

Trial Locations

Locations (1)

Hezhou Center for Disease Prevention and Control; 🇨🇳 Hezhou, Guangxi, China

Hezhou Center for Disease Prevention and Control

🇨🇳Hezhou, Guangxi, China