Approval Probability
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ML Risk
Also known as GSK Biologicals' HPV vaccine (GSK1674330A)
GSK Biologicals' HPV vaccine · 3 trials · 4 indications
Titers are displayed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.
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 human papillomavirus \[HPV\]16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm. |
| Gardasil Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Gardasil® (Merck's human papillomavirus \[HPV\] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm. |
| 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. |
| Group A | EXPERIMENTAL | - |
| Group B | EXPERIMENTAL | - |
| Group C | EXPERIMENTAL | - |
| Group D | EXPERIMENTAL | - |
| Group E | EXPERIMENTAL | - |
| Group F | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) | BIOLOGICAL | Three doses administered intramuscularly at months 0, 1 and 6 |
| Gardasil ® (Merck & Co. Inc) | BIOLOGICAL | Three doses administered intramuscularly at months 0, 2 and 6 |
| Placebo | BIOLOGICAL | One dose administered intramuscularly at month 1 to maintain blinding |
| 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. |
| GSK Biologicals' HPV vaccine (GSK1674330A) | BIOLOGICAL | Intramuscular administration, 5 different formulations |
| Cervarix TM | BIOLOGICAL | Intramuscular administration |
Inclusion Criteria: * A woman whom the investigator believes that she or her legally acceptable representative (in the event that the subject is illiterate) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). * A woman betwee...
GSK Biologicals' HPV vaccine is being developed for the prevention of cervical intraepithelial neoplasia and papillomavirus infections. It is a vaccine candidate studied in females, including young adolescent women and healthy adult women, with clinical trials enrolling participants from 10 years of age and older.
GSK Biologicals' HPV vaccine is developed by GSK plc, which trades under the ticker GSK. The vaccine is also identified in clinical documentation as GSK1674330A and as the HPV 16/18 vaccine 580299.
GSK Biologicals' HPV vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA. Two completed trials are registered, including one Phase 3 study and one Phase 1 study, with a combined enrollment of 1,646 participants.
GSK Biologicals' HPV vaccine has been evaluated in completed trials NCT00478621, a Phase 1 safety and immunogenicity study in Belgium, and NCT00423046, a Phase 3 immunogenicity study in the United States comparing it with Merck's Gardasil in healthy females aged 18 to 45.
Yes, GSK Biologicals' HPV vaccine is also known as Cervarix. Other names used in study records include GSK1674330A, GSK Biologicals HPV 16/18 vaccine 580299, and GSK Biologicals' HPV-16/18 L1 AS04 vaccine.