Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental |
|
|
| Control Group | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational live attenuated mumps vaccine | Biological | The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
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:
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):
Both
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jingchen Ma | Hubei Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dingxing County Center for Disease Control and Prevention | Dingxing | Hebei | 072650 | China |
Not provided
| ID | Term |
|---|---|
| D009107 | Mumps |
| ID | Term |
|---|---|
| D019351 | Rubulavirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| control live attenuated mumps vaccine | Biological | The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd. |
|
| 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 |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |