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, live is used to prevent varicella, commonly known as chickenpox. It is a live attenuated vaccine developed by Sinovac Biotech, Ltd (ticker SVA) for immunization against the varicella virus in infectious disease prevention. Clinical studies have evaluated it in healthy children and in healthy people aged 13 years and older.
Varicella vaccine, live is developed and manufactured by Sinovac Biotech, Ltd, which trades under the ticker SVA. The vaccine is produced by Sinovac (Dalian) Vaccine Technology Co., Ltd and Sinovac Vaccine Technology Co., Ltd, both part of the Sinovac organization. It is a live attenuated varicella vaccine intended for varicella immunization.
Varicella vaccine, live is in Phase 3 clinical development. It is an investigational live attenuated vaccine and is not described as approved. The program includes three Phase 3 studies, with one completed, one currently active, and one not yet recruiting, totaling 3,342 participants across the trials.
Varicella vaccine, live has been studied in Phase 3 trials including NCT06314724 in healthy children aged 12 to 15 months in the Philippines, which is completed with 642 participants, and NCT05015686 in healthy people aged 13 years and older in China, which is enrolling by invitation with 2,400 participants. A third trial, NCT07473427, is planned in Vietnam.
Yes. Varicella vaccine, live is also known as the live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd and by Sinovac Vaccine Technology Co., Ltd. These names refer to the same Sinovac live attenuated varicella vaccine program developed for prevention of varicella, or chickenpox.
Varicella vaccine, live is a live attenuated vaccine, meaning it uses a weakened form of the varicella virus to stimulate immunity. It is given to healthy volunteers, including children from 12 months of age and people aged 13 years and older. The Phase 3 trials are randomized, double-blind, and active-controlled.