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Investigational live attenuated mumps vaccine · 2 trials · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Experimental Group | EXPERIMENTAL | * Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; * Intervention: investigational live attenuated mumps vaccine; |
| Control Group | ACTIVE_COMPARATOR | * Single intramuscular injection of the control vaccine (0.5 ml) on Day 0; * Intervention: control live attenuated mumps vaccine; |
| Name | Type | Description |
|---|---|---|
| investigational live attenuated mumps vaccine | BIOLOGICAL | The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. |
| control live attenuated mumps vaccine | BIOLOGICAL | The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd. |
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 o...
The investigational live attenuated mumps vaccine is used for the prevention of mumps, an infectious disease. It is being developed for use in healthy infants aged 8 months and older. The vaccine is currently in Phase 3 clinical development and is not yet approved for use.
The investigational live attenuated mumps vaccine is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company traded under the ticker SVA. The company is conducting Phase 3 clinical trials to evaluate the vaccine's safety and immunogenicity in healthy infants.
The investigational live attenuated mumps vaccine is in Phase 3 clinical development. Two Phase 3 trials have been completed, with a total enrollment of 2,290 healthy infants. The vaccine remains investigational and has not been approved by regulatory authorities.
The investigational live attenuated mumps vaccine has been studied in two completed Phase 3 trials: NCT02692599 with 1,150 participants and NCT05065177 with 1,140 participants. Both trials evaluated safety and immunogenicity in healthy infants aged 8 months and older in China.
No, the investigational live attenuated mumps vaccine is not a monoclonal antibody. Despite being classified under the modality of monoclonal antibody in some databases, the product is described as a live attenuated vaccine. It is designed to elicit an immune response against the mumps virus.