Mumps
Conditions
Keywords
live attenuated mumps vaccine, safety, immunogenicity, infant
Brief summary
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
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.
Interventions
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
BIOLOGICALcontrol live attenuated mumps vaccine
The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd.
Sponsors
Sinovac Research and Development Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Months to 18 Months
Healthy volunteers
Yes
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);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The seroconversion rates (SCRs) of susceptible subjects in each group | 28 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidences of adverse events (AEs) of each group | 28 days | AEs occurred within 28 days after injection will be collected. |
| The incidences of serious adverse events (SAEs) of each group | 28 days | SAEs occurred within 28 days after injection will be collected. |
| The post-immune geometric mean titers (GMTs) of susceptible subjects in each group | 28 days | Subjects whose pre-immune HI antibody level \< 1:2 are considered susceptible. |
| The overall SCRs of each group | 28 days | 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. |
| The overall post-immune GMTs of each group | 28 days | The GMTs of all the subjects in each group. |
Countries
China
Outcome results
None listed