Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gardasil · 1 trial · 2 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.
| 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. |
| 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 |
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...
Gardasil is a vaccine used for infections caused by papillomavirus, specifically human papillomavirus (HPV). It is indicated for the prevention of HPV infections. The drug was studied in healthy females aged 18 to 45 years in a clinical trial setting.
Gardasil is developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The company conducted a Phase 3 clinical trial to evaluate the vaccine's immunogenicity.
Gardasil is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind, active-controlled study. The drug is investigational and not yet approved for use.
Gardasil has been studied in one completed Phase 3 clinical trial, identified as NCT00423046. This trial evaluated the immunogenicity of GSK's HPV vaccine compared with Gardasil in healthy females aged 18 to 45 years in the United States.
Yes, Gardasil is classified as a monoclonal antibody. It is being developed for the prevention of papillomavirus infections, which are a cause of various diseases. The drug is administered as a vaccine to elicit an immune response.
Gardasil is a monoclonal antibody that targets human papillomavirus (HPV). It works by stimulating the immune system to produce a protective response against HPV infections, thereby preventing the infections and associated diseases. The exact mechanism involves the antibody's interaction with viral components.