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. ...
The investigational live attenuated varicella vaccine is used for varicella, the disease commonly known as chickenpox. It is being developed for healthy adults, adolescents, and children aged 1 year and older. The vaccine is currently in Phase 3 clinical development and is not yet approved.
Sinovac Biotech, Ltd (ticker: SVA) is developing the investigational live attenuated varicella vaccine. The company is conducting clinical trials for this vaccine in China, where the studies have been completed.
The investigational live attenuated varicella vaccine is in Phase 3 clinical development. It has completed three clinical trials, including two Phase 3 studies and one Phase 1 study. The vaccine remains investigational and has not been approved for use.
The investigational live attenuated varicella vaccine has been studied in three completed trials in China. NCT02965404 was a Phase 1 safety study in 270 participants. NCT02981836 was a Phase 3 blind, randomized, controlled study in 5,997 participants. NCT05150392 was a Phase 3 open-label trial in 1,193 participants evaluating immunity persistence and booster immunization.
No, the investigational live attenuated varicella vaccine is not a monoclonal antibody. It is a live attenuated vaccine, which uses a weakened form of the varicella virus to trigger an immune response. The clinical trials for this vaccine have enrolled a total of 7,460 participants.