Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Investigational sIPV · 1 trial · 1 indication
Subjects whose pre-immune antibody level \< 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2).
| Arm | Type | Description |
|---|---|---|
| Experimental Group | EXPERIMENTAL | The investigational vaccine was manufactured by Sinovac Vaccine Technology Co., Ltd. Intervention: investigational sIPV |
| Control Group | ACTIVE_COMPARATOR | The control vaccine was manufactured by Sanofi Pasteur Company. Intervention: control IPV |
| Name | Type | Description |
|---|---|---|
| Investigational sIPV | BIOLOGICAL | Three intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the investigational vaccine (0.5 ml) at 18 months; Intervention: investigational sIPV |
| Control IPV | BIOLOGICAL | Three intramuscular injections of the control vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the control vaccine (0.5 ml) at 18 months; Intervention:control IPV |
Inclusion Criteria: * Healthy volunteer between 60-90 days old; * Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators; * Proven legal identity; * Participants ...
Investigational sIPV is a vaccine being developed for the prevention of poliomyelitis, a viral infectious disease that can cause paralysis. It is designed for use in infants, with a clinical trial specifically studying its immunogenicity and safety in 2-month-old infants.
Investigational sIPV is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company listed on the NASDAQ under the ticker symbol SVA. The company is conducting clinical research to evaluate the vaccine's safety and immune response in infants.
Investigational sIPV is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy for the prevention of poliomyelitis.
Investigational sIPV has one completed Phase 3 clinical trial, identified as NCT03526978. This study, titled "An Immunogenicity and Safety Study of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants," was conducted in China with 1,200 participants. The trial was randomized, double-blind, and active-controlled.
Yes, Investigational sIPV is also known as Sabin Inactivated Poliovirus Vaccine (Vero Cell), as indicated by the clinical trial title. This alternative name reflects the vaccine's use of the Sabin strain of the poliovirus, inactivated and produced in Vero cells.