Safety and Immunogenicity Study of Live Attenuated Mumps Vaccines in Healthy Infants
NCT ID: NCT02692599
Last Updated: 2017-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1150 participants
INTERVENTIONAL
2016-01-31
2016-07-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Experimental Group
* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0;
* Intervention: investigational live attenuated mumps vaccine;
investigational live attenuated mumps vaccine
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
Control Group
* Single intramuscular injection of the control vaccine (0.5 ml) on Day 0;
* Intervention: control live attenuated mumps vaccine;
control live attenuated mumps vaccine
The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd.
Interventions
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investigational live attenuated mumps vaccine
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
control live attenuated mumps vaccine
The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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:
1. Any subunit vaccine or inactivated vaccine within 14 days prior to study entry;
2. Any live attenuated vaccine within 28 days prior to study entry;
3. Any other investigational medicine(s) within 30 days prior to study entry;
4. Blood product (e.g., immunoglobulin) within 3 months prior to study entry;
5. 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):
1. Receipt of any other investigational or unregistered product (drug or vaccine);
2. 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;
3. Receipt of immunoglobulin and/or blood product;
4. Newly diagnosed autoimmune disease or immunodeficiency (e.g., HIV infection);
8 Months
18 Months
ALL
Yes
Sponsors
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Sinovac (Dalian) Vaccine Technology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jingchen Ma
Role: PRINCIPAL_INVESTIGATOR
Hubei Provincial Center for Disease Control and Prevention
Locations
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Dingxing County Center for Disease Control and Prevention
Baoding, Hebei, China
Countries
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Other Identifiers
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PRO-MUMPS-3001
Identifier Type: -
Identifier Source: org_study_id