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...
It is a live attenuated varicella vaccine developed by Sinovac Biotech to prevent chickenpox, also known as varicella. It is intended for immunization, including in young children, with trial eligibility starting at 1 year of age. The vaccine is manufactured at commercialized scale.
Sinovac Biotech, Ltd. develops this live attenuated varicella vaccine. Sinovac is a biopharmaceutical company whose common stock trades under the ticker SVA. The vaccine is manufactured at commercialized scale.
The Sinovac varicella vaccine has completed a Phase 3 clinical trial. It is an investigational product in clinical development for varicella prevention. The Phase 3 lot-consistency study has been completed, and no active trials for this vaccine are currently listed.
The vaccine was evaluated in a single Phase 3 trial, NCT03555071, titled A Phase 3 Lot-consistency Clinical Trial of Live Attenuated Varicella Vaccine. The completed study enrolled 1,197 healthy volunteers aged 1 year and older, was randomized and double-blind, and used an active-controlled design.
The Sinovac varicella vaccine is an investigational product that has completed Phase 3 clinical development. It is not described as FDA approved. Its only listed trial, NCT03555071, is a completed Phase 3 lot-consistency study in varicella.