Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals' HPV-16/18 Vaccine · 1 trial · 2 indications
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
| Arm | Type | Description |
|---|---|---|
| Cervarix Group | EXPERIMENTAL | Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48. |
| Havrix Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Havrix™ (hepatitis A vaccine \[HAV\]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) | BIOLOGICAL | Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule |
| Havrix™ | BIOLOGICAL | Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule. |
Inclusion Criteria: * A female who enrolled in the immunological subset of the 580299-013 study, received the three doses of vaccine/control according to the treatment allocation and completed the 580299-013 study. * Written informed assent obtained from the subject and written informed consent obt...
GSK Biologicals' HPV vaccine is used for the prevention of cervical intraepithelial neoplasia and papillomavirus infections. It is being developed for young adolescent and adult women, with clinical trials conducted in healthy female volunteers aged 10 years and older.
GSK Biologicals' HPV vaccine is developed by GSK plc, which trades under the ticker GSK. The vaccine is currently in clinical development and is not yet approved for commercial use.
GSK Biologicals' HPV vaccine is in Phase 1 clinical development. It has completed one Phase 1 trial and one Phase 3 trial, but it remains investigational and has not received regulatory approval.
GSK Biologicals' HPV vaccine has been studied in two completed trials. NCT00316706 was a Phase 3 trial in 1,245 young adolescent women across Colombia, Germany, Honduras, Panama, and Taiwan. NCT00478621 was a Phase 1 safety and immunogenicity trial in 540 young adult women in Belgium.
GSK Biologicals' HPV vaccine is a monoclonal antibody modality designed to target human papillomavirus. It is intended to generate an immune response against HPV types 16 and 18, which are associated with cervical intraepithelial neoplasia and papillomavirus infections.