Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Boostrix Polio · 1 trial · 1 indication
Seroprotection against diphtheria and tetanus is defined as anti-diphtheria and anti-tetanus antibody titres greater than or equal to 0.1 International Units per Milliliter (≥ 0.1 IU/mL).
Titers are given as geometric mean titers (GMTs) calculated on all subjects and expressed as Enzyme-linked Immunosorbent Assay Units per Milliliter (EL.U/mL).
Seroprotection against polio 1, 2 and 3 is defined as anti-polio 1, 2 and 3 antibody titers greater than or equal to 8 Effective Dose 50% (≥ 8 ED50).
| Arm | Type | Description |
|---|---|---|
| Cervarix Group | EXPERIMENTAL | Subjects who received GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) at Month 0, 1 and 6. |
| Boostrix Polio → Cervarix Group | EXPERIMENTAL | Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) at Month 1, 2 and 7. |
| Cervarix + Boostrix Polio Group | EXPERIMENTAL | Subjects who received GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0. |
| Name | Type | Description |
|---|---|---|
| Boostrix ® Polio | BIOLOGICAL | One dose of vaccine administered intramuscularly |
| GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) | BIOLOGICAL | Three doses of vaccine administered intramuscularly, with the second and third dose give one month and six months after the first dose respectively |
Inclusion Criteria: * Subjects who the investigator believes that they and their parents/legally acceptable representatives can, and will, comply with the requirements of the protocol should be enrolled in the study. * A female between, and including, 10 and 18 years of age at the time of the first...
Boostrix Polio is used for infections and papillomavirus. It is an investigational therapy being developed by GSK plc for infectious disease indications. The drug is currently in Phase 3 clinical development, meaning it is still being studied and has not yet been approved for use.
Boostrix Polio is developed by GSK plc, a biopharmaceutical company traded on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and immunogenicity of the drug in healthy female subjects.
Boostrix Polio is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being studied for use in infections and papillomavirus.
Boostrix Polio has one completed Phase 3 clinical trial registered as NCT00426361. The trial, titled 'Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects,' enrolled 751 participants in France, Germany, and Spain.
Boostrix Polio is a monoclonal antibody, a type of drug designed to target specific molecules in the body. However, the specific molecular target for Boostrix Polio has not been disclosed, so the exact mechanism of action is not publicly detailed.