Safety and Immunogenicity Study of Live Attenuated Mumps Vaccines in Healthy Infants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the immunogenicity and safety of a live attenuated mumps vaccine in healthy infants between 8 - 18 months old with a commercialized live attenuated mumps vaccine as the control vaccine.

Detailed Description
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This study is a randomized, blind, single-center, controlled phase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of a live attenuated mumps vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control vaccine is a commercialized live attenuated mumps vaccine manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd. All participants are healthy infants between 8 - 18 months old, and will be randomly assigned into experimental group or control group in the ratio 1:1.

Official Title
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A Blind, Randomized and Controlled Clinical Trial With Live Attenuated Mumps Vaccines in Healthy Infants

Conditions
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Mumps

Intervention / Treatment
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* Biological: investigational live attenuated mumps vaccine
* Biological: control live attenuated mumps vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteer between 8 - 18 months old; Proven legal identity; Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study; Complying with the requirement of the study protocol; Exclusion Criteria: Axillaty temperature > 37.0 °C; Any significant abnormity of heart, lung, liver, spleen, lymph nodes, or pharynx; Acute disease or acute stage of chronic disease within 7 days prior to study entry; Prior vaccination with mumps vaccine or with history of mumps infection; History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) about vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc; Receipt of any of the following products: Any subunit vaccine or inactivated vaccine within 14 days prior to study entry; Any live attenuated vaccine within 28 days prior to study entry; Any other investigational medicine(s) within 30 days prior to study entry; Blood product (e.g., immunoglobulin) within 3 months prior to study entry; Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry; Epilepsy (except febrile seizures), history of seizures or convulsions, or a family history of mental illness; Autoimmune disease or immunodeficiency; Congenital malformation, developmental disorders, or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders; Severe malnutrition; Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities); Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators; Participants with the following conditions between day 0 - 28 of this study would be included in the full analysis set (FAS), but would be excluded from the per protocol set (PPS): Receipt of any other investigational or unregistered product (drug or vaccine); Receipt of immunosuppressant (corticosteroid dosage that equivalent to or above 0.5 mg prednisone/kg weight/day) for > 14 days consecutively, except for inhalant or locally administrated corticosteroid; Receipt of immunoglobulin and/or blood product; Newly diagnosed autoimmune disease or immunodeficiency (e.g., HIV infection);

Ages Eligible for Study
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Minimum Age: 8 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; Intervention: investigational live attenuated mumps vaccine; | Biological: investigational live attenuated mumps vaccine<br>* The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.<br>|
| Active Comparator: Control Group<br>Single intramuscular injection of the control vaccine (0.5 ml) on Day 0; Intervention: control live attenuated mumps vaccine; | Biological: control live attenuated mumps vaccine<br>* The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The seroconversion rates (SCRs) of susceptible subjects in each group | Subjects whose pre-immune HI antibody level < 1:2 are considered susceptible; among these subjects, those with post-immune HI antibody level ≥ 1:2 are considered seroconverted. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidences of adverse events (AEs) of each group | AEs occurred within 28 days after injection will be collected. | 28 days | 
| The incidences of serious adverse events (SAEs) of each group | SAEs occurred within 28 days after injection will be collected. | 28 days | 
| The post-immune geometric mean titers (GMTs) of susceptible subjects in each group | Subjects whose pre-immune HI antibody level < 1:2 are considered susceptible. | 28 days | 
| The overall SCRs of each group | Subjects whose pre-immune HI antibody level < 1:2 and post-immune antibody level ≥ 1:2, or those whose pre-immune antibody level ≥ 1:2 and the increase of post-immune HI antibody level ≥ 4 folds are considered seroconverted. | 28 days | 
| The overall post-immune GMTs of each group | The GMTs of all the subjects in each group. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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live attenuated mumps vaccine, safety, immunogenicity, infant