Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Varicella Vaccine
Varicella vaccine, live · 3 trials · 3 indications
The seroresponse rate of VZV antibodies on Day 42 after vaccination among susceptible population.
The seroconversion rate of the antibody 28 days among all subjects after the second vaccination.
The GMT of the antibody 28 days among all subjects after the second vaccination.
| Arm | Type | Description |
|---|---|---|
| No vaccination history group | EXPERIMENTAL | Participants aged 1-12 years with no vaccination history of varicella-containing vaccine |
| Vaccination history group | EXPERIMENTAL | Participants aged 2-12 years have received 1 dose of varicella vaccine |
| Varicella vaccine group | EXPERIMENTAL | Participants will receive a single dose of investigational varicella vaccine on Day 0. |
| Varivax | ACTIVE_COMPARATOR | Participants will receive a single dose of Varivax on Day 0. |
| Experimental Group with the immunization course of 0,28 days, 0,42 days or 0,56 days | EXPERIMENTAL | 960 subjects (including 480 children aged 13-17 years and 480 adults aged 18 years and older) will receive two doses of experimental vaccine with the immunization course of 0,28 days, 0,42 days or 0,56 days. |
| Control Group | ACTIVE_COMPARATOR | 960 subjects (including 480 children aged 13-17 years and 480 adults aged 18 years and older) will receive two doses of control vaccine with the immunization course of 0,28 days, 0,42 days or 0,56 days. |
| Experimental Group with the immunization course of 0, 70 days | EXPERIMENTAL | 320 subjects (including 160 children aged 13-17 years and 160 adults aged 18 years and older) will receive two doses of the experimental vaccine with the immunization course of 0, 70 days. |
| Placebo group | PLACEBO_COMPARATOR | 160 subjects (including 80children aged 13-17 years and 80 adults aged 18 years and older) will receive two doses of the placebo with the immunization course of 0, 70 days. |
| Name | Type | Description |
|---|---|---|
| Varicella Vaccine | BIOLOGICAL | Varicella vaccine manufactured by Sinovac |
| Varivax | BIOLOGICAL | lyophilized powder,subcutaneous injection |
| Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd | BIOLOGICAL | live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection |
| Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd | BIOLOGICAL | live varicella-zoster virus in trehalose,human serum albumin,sodium glutamate,sucrose,glucose,carbamide,arginine and injection water per injection |
| Placebo | BIOLOGICAL | Sodium chloride and distilled water |
Inclusion Criteria: 1. Healthy children aged 1-12 years; 2. Vaccination history: * Participants aged 1 year old: no vaccination history with any varicella containing vaccine; * Participants aged 2\~12 years old: no vaccination history with any varicella containing vaccine, or have received 1...
Varicella Vaccine is a live vaccine used for the prevention of varicella, commonly known as chickenpox. It is being developed for use in healthy children to provide immunity against the varicella-zoster virus, which causes chickenpox.
Varicella Vaccine is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol SVA.
Varicella Vaccine is currently in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. Clinical trials are ongoing to evaluate its immunogenicity and safety in healthy children.
Varicella Vaccine is being studied in two Phase 3 clinical trials. One trial, NCT06314724, has been completed in the Philippines with 642 healthy children aged 12 to 15 months. Another trial, NCT07473427, is planned in Vietnam with 300 healthy children aged 1 year and older.
Varicella Vaccine is a live attenuated vaccine that works by stimulating the immune system to produce a protective response against the varicella-zoster virus. This helps the body develop immunity to chickenpox without causing the full disease.