Mumps Clinical Trial
Official title:
A Blind, Randomized and Controlled Clinical Trial With Live Attenuated Mumps Vaccines in Healthy Infants
Verified date | July 2021 |
Source | Sinovac Biotech Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1140 |
Est. completion date | April 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Months to 18 Months |
Eligibility | 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) to 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 (e.g., 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 (dosage of corticosteroid = that in 0.5 mg prednisone per kg weight per day) for > 14 days consecutively, except for inhalant or locally administrated corticosteroid; 3. Receipt of immunoglobulin and/or other blood product; 4. Newly diagnosed autoimmune disease or immunodeficiency (e.g., HIV infection); |
Country | Name | City | State |
---|---|---|---|
China | Dingxing County Center for Disease Control and Prevention | Dingxing | Hebei |
Lead Sponsor | Collaborator |
---|---|
Sinovac Research and Development Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The incidences of adverse events (AEs) of each group | AEs occurred within 28 days after injection will be collected. | 28 days | |
Secondary | The incidences of serious adverse events (SAEs) of each group | SAEs occurred within 28 days after injection will be collected. | 28 days | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | The overall post-immune GMTs of each group | The GMTs of all the subjects in each group. | 28 days |
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