Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
It is a vaccine candidate developed by Sinovac Biotech, Ltd. for the prevention of mumps. It uses a live attenuated approach, meaning it contains a weakened form of the virus intended to stimulate an immune response. It is currently in Phase 3 clinical development and is not yet approved.
Sinovac Biotech, Ltd. is developing the investigational live attenuated mumps vaccine. Sinovac is a China-based biopharmaceutical company that trades under the ticker SVA. The company has completed two Phase 3 trials of the vaccine in healthy infants in China.
The investigational live attenuated mumps vaccine is in Phase 3 clinical development. Two Phase 3 trials have been completed, and no trials are currently active. The vaccine is investigational and has not been approved for use.
Two completed Phase 3 trials have evaluated the vaccine: NCT05065177, which enrolled 1,140 healthy infants, and NCT02692599, which enrolled 1,150 healthy infants. Both were randomized, double-blind, active-controlled safety and immunogenicity studies conducted in China in infants from 8 months of age.
The investigational live attenuated mumps vaccine is being developed for the prevention of mumps, an infectious disease. Both completed Phase 3 trials enrolled healthy infants in China to evaluate safety and immunogenicity. The vaccine remains investigational and is not yet approved for use.
Across the two completed Phase 3 trials, 2,290 participants were enrolled. NCT05065177 enrolled 1,140 healthy infants and NCT02692599 enrolled 1,150 healthy infants. Both studies were randomized, double-blind, and active-controlled, and both were conducted in China.