Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Investigational live attenuated varicella vaccine · 3 trials · 1 indication
seroconversion rates of antibody 1 year after primary immunization
Seropositivity rate of antibody 30 days after booster immunization
The first 30 cases of varicella occurred 30 days after injection will be collected.
The protection rate will be calculated based on the reported cases occurred 30 days after injection.
AEs occurred within 30 days after injection will be collected.
| Arm | Type | Description |
|---|---|---|
| Booster immunization 1 year after primary immunization | EXPERIMENTAL | Subjects C0001-C0400 except C0243 received 1 dose of booster immunization 1 year after primary immunization. |
| Booster immunization 2 year after primary immunization | EXPERIMENTAL | Subjects C0401-C0800 except C0556 received 1 dose of booster immunization 2 years after primary immunization. |
| Booster immunization 3 year after primary immunization | EXPERIMENTAL | Subjects C0801-C1197 received 1 dose of booster immunization 3 years after primary immunization. |
| Experimental Group | EXPERIMENTAL | * Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; * Intervention: investigational live attenuated varicella vaccine; |
| Control Group | SHAM_COMPARATOR | * Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0; * Intervention: diluent of lyophilized vaccine; |
| Positive Control Group | ACTIVE_COMPARATOR | * Single intramuscular injection of the control vaccine (0.5 ml) on Day 0; * Intervention: control live attenuated varicella vaccine. |
| Negative Control Group | SHAM_COMPARATOR | * Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0; * Intervention: diluent of lyophilized vaccine. |
| Name | Type | Description |
|---|---|---|
| Investigational live attenuated varicella vaccine | BIOLOGICAL | The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.And the 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 |
| diluent of lyophilized vaccine | BIOLOGICAL | The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. |
| control live attenuated varicella vaccine | BIOLOGICAL | The control vaccine was manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP) |
Inclusion Criteria: * Received one dose live attenuated varicella vaccine in the phase Ⅲ lot-consistency clinical trial; * 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. ...
It is being developed for the prevention of varicella, also known as chickenpox. The vaccine is designed to protect against infection with the varicella-zoster virus. It is an investigational product and has not been approved for commercial use.
The vaccine is being developed by Sinovac Biotech, Ltd., a Chinese biopharmaceutical company. Sinovac trades on the Nasdaq under the ticker symbol SVA. The company is known for developing vaccines for infectious diseases.
The vaccine is in Phase 3 clinical development. It has completed three clinical trials, including two Phase 3 studies and one Phase 1 study. It is not yet approved by the FDA or any other regulatory agency.
Three completed trials are registered: NCT05150392, a Phase 3 study of immunity persistence and booster response in 1,193 participants; NCT02981836, a Phase 3 randomized, controlled study in 5,997 participants; and NCT02965404, a Phase 1 safety study in 270 participants. All trials were conducted in China.
The vaccine uses a live attenuated, or weakened, form of the varicella-zoster virus to stimulate an immune response without causing disease. This is a well-established approach for viral vaccines. The weakened virus prompts the body to develop immunity against future infection.