Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HPV Vaccine Cervarix TM · 1 trial · 1 indication
Only groups which had received the HBV vaccine were included in the analysis. Subjects included were seronegative for anti-HBs (antibody titer \< 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination. Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL.
Only groups which had received the HPV vaccine were included in the analysis. Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL. Subjects included were seronegative for anti-HPV-16 (antibody titer \< 8 EL.U/mL) and anti-HPV-18 (antibody titer \< 7 EL.U/mL) prior to vaccination.
Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs). Only groups which had received the HPV vaccine were included in the analysis. Subjects included were seronegative for anti-HPV-16 (antibody titer \< 8 EL.U/mL) and anti-HPV-18 (antibody titer \< 7 EL.U/mL) prior to vaccination.
| Arm | Type | Description |
|---|---|---|
| Cervarix & Engerix Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Cervarix™ (Human Papillomavirus \[HPV\] vaccine) co-administered with Engerix™ (Hepatitis B \[HBV\] vaccine) according to a 0, 1, 6-month schedule. |
| Cervarix Group | EXPERIMENTAL | Subjects received 3 doses of Cervarix™ (Human Papillomavirus \[HPV\] vaccine) according to a 0, 1, 6-month schedule. |
| Engerix Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Engerix™ (Hepatitis B \[HBV\] vaccine) according to a 0, 1, 6-month schedule. |
| Name | Type | Description |
|---|---|---|
| HPV Vaccine (GSK580299) Cervarix TM | BIOLOGICAL | IM administration |
| Engerix B | BIOLOGICAL | IM administration |
Inclusion Criteria: * Subjects who the investigator believes that they and/or their parents/legally acceptable representatives (LARs) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. * A fema...
Cervarix is a vaccine used for infections caused by papillomavirus, which includes human papillomavirus (HPV) infections. It is being developed for the prevention of HPV-related conditions. The vaccine is intended for use in healthy female subjects, as studied in clinical trials.
Cervarix is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is responsible for the research, development, and manufacturing of the vaccine.
Cervarix is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the vaccine is being evaluated for its immunogenicity and safety.
Cervarix has one completed Phase 3 clinical trial registered under NCT00652938. This trial evaluated the immunogenicity and safety of the HPV vaccine when co-administered with another vaccine in healthy female subjects. The trial enrolled 744 participants in the Netherlands and Sweden.
Cervarix is a vaccine against human papillomavirus (HPV), which is a type of papillomavirus. It is designed to prevent infections caused by HPV. The clinical trial for Cervarix specifically studied its use in healthy female subjects aged 9 years and older.