Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Different formulations of GSK Biologicals' HPV vaccine · 1 trial · 1 indication
Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)
Concentrations given as Geometric Means Concentrations (GMCs)
Titers given as Geometric Mean Titers (GMTs)
| Arm | Type | Description |
|---|---|---|
| Cervarix + Boostrix/Menactra Group | EXPERIMENTAL | Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6. |
| Cervarix + Menactra/Boostrix Group | EXPERIMENTAL | Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6. |
| Cervarix + Boostrix + Menactra Group | EXPERIMENTAL | Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6. |
| Boostrix/Cervarix Group | EXPERIMENTAL | Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7. |
| Menactra/Cervarix Group | EXPERIMENTAL | Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7. |
| Cervarix Group | EXPERIMENTAL | Subjects received Cervarix at Months 0, 1 and 6. |
| Name | Type | Description |
|---|---|---|
| Different formulations of GSK Biologicals' HPV vaccine (580299) | BIOLOGICAL | Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively |
| Menactra TM | BIOLOGICAL | One dose of vaccine administered intramuscularly |
| Boostrix TM | BIOLOGICAL | One dose of vaccine administered intramuscularly |
Inclusion Criteria: * Subjects who the investigator believes that they can, and will, comply with the requirements of the protocol should be enrolled in the study. * A female between, and including, 11 and 18 years of age at the time of the first vaccination. * Written informed consent obtained fro...
It is an investigational vaccine developed by GSK Biologicals, part of GSK plc, for the prevention of papillomavirus infections. It is a vaccine modality in the infectious disease therapeutic area. The asset is in Phase 3 clinical development and has been studied in a completed trial of 1,330 healthy female subjects.
It is being developed for infections and papillomavirus. The vaccine is intended for use in healthy female subjects, with clinical study enrollment starting at 11 years of age. The completed Phase 3 trial evaluated safety and immunogenicity when co-administered with other vaccines.
GSK Biologicals, part of GSK plc, is the developer of this HPV vaccine. GSK plc trades under the ticker GSK. The vaccine is identified in development records as 580299.
Different formulations of GSK Biologicals' HPV vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved. One Phase 3 trial has been completed, and there are no active trials listed for this asset.
The vaccine has been studied in one completed Phase 3 trial, NCT00369824, titled Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects. The trial enrolled 1,330 participants in the United States and was randomized and controlled.
Yes, Different formulations of GSK Biologicals' HPV vaccine is also known as 580299. The number 580299 is the development identifier used for this GSK Biologicals HPV vaccine asset. Both names refer to the same Phase 3 investigational vaccine for papillomavirus infections.