Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vaccine manufactured at commercialized scale · 1 trial · 1 indication
Subjects whose pre-immune antibody titer \< 1:4 are considered susceptible. The GMT were measured using the method of Fluorescent Antibody to Membrane Antigen (FAMA).
Subjects whose pre-immune antibody titer\< 1:4 and post-immune antibody titer≥ 1:4, or those whose pre-immune antibody titer≥1:4 and the increase of post-immune antibody titer≥4 folds are considered seroconverted.
| Arm | Type | Description |
|---|---|---|
| Experimental Group1 | EXPERIMENTAL | The investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale. Intervention: Live attenuated varicella vaccine manufactured at commercialized scale |
| Experimental Group2 | EXPERIMENTAL | The investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale. Intervention: Live attenuated varicella vaccine manufactured at commercialized scale |
| Experimental Group3 | EXPERIMENTAL | The investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale. Intervention: Live attenuated varicella vaccine manufactured at commercialized scale |
| Control Group | ACTIVE_COMPARATOR | The control vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at trial-scale. Intervention: Live attenuated varicella vaccine manufactured at trial-scale |
| Name | Type | Description |
|---|---|---|
| Vaccine manufactured at commercialized scale | BIOLOGICAL | Single subcutaneous injection of the investigated live attenuated varicella vaccine (0.5 ml) on Day 0 |
| Vaccine manufactured at trial-scale | BIOLOGICAL | Single subcutaneous injection of the control live attenuated varicella vaccine (0.5 ml) on Day 0 |
Inclusion Criteria: * Healthy volunteer between 1-3 years old; * legal identity; * Guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study. Exclusion Criteria: * Prior vaccination...
The varicella vaccine manufactured at commercialized scale is used for the prevention of varicella, commonly known as chickenpox. It is a live attenuated vaccine being developed by Sinovac Biotech, Ltd for use in infectious disease prevention.
Sinovac Biotech, Ltd (ticker: SVA) is developing the varicella vaccine manufactured at commercialized scale. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy in preventing varicella.
The varicella vaccine manufactured at commercialized scale is in Phase 3 clinical development. It is an investigational vaccine, not yet approved, and is being studied for the prevention of varicella in a completed Phase 3 trial.
The varicella vaccine manufactured at commercialized scale has one completed Phase 3 clinical trial, NCT03555071, titled "A Phase 3 Lot-consistency Clinical Trial of Live Attenuated Varicella Vaccine." This trial enrolled 1197 participants and was a randomized, double-blind, active-controlled study.
No, the varicella vaccine manufactured at commercialized scale is not a monoclonal antibody. It is a live attenuated vaccine, as indicated by the clinical trial title. The modality listed in the development data is monoclonal antibody, but the actual product is a vaccine.
The Phase 3 trial NCT03555071 enrolled 1197 participants, including healthy volunteers aged 1 year and older. The study was randomized, double-blind, and active-controlled, comparing the vaccine against an active control to assess lot consistency and efficacy in preventing varicella.