Clinical trial NCT04364399: Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mumps
Keywords: Mumps
Mumps vaccine
measles, mumps and rubella combined vaccine, live
infants
Lead sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-28
Enrollment: 920
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The seroconversion rate of hemagglutination inhibition (HI) antibody
timeFrame: the 30th day after vaccination
Secondary outcomes:
measure: The GMT of HI antibody
timeFrame: the 30th day after vaccination
measure: The incidence of the solicited local and systemic adverse reactions
timeFrame: from day 0 to day 14 after vaccination
measure: The incidence of the unsolicited adverse events
timeFrame: from day 0 to day 30 after immunization
measure: The incidence of the serious adverse events
timeFrame: from day 0 to day 30 after immunization
Other outcomes:
Locations:
city: Hezhou
country: China
facility: Hezhou Center for Disease Prevention and Control
state: Guangxi
Study officials:
affiliation: Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
name: Lirong Huang, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: