Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals' HPV vaccine 580299 · 1 trial · 1 indication
Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 concentrations ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration lower than (\<) 8/7 EL.U/mL, respectively.
Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.
| Arm | Type | Description |
|---|---|---|
| Cervarix 1 Group | EXPERIMENTAL | Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| Cervarix 2 Group | ACTIVE_COMPARATOR | Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| Cervarix 3 Group | EXPERIMENTAL | Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' HPV vaccine 580299 | BIOLOGICAL | Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly. |
Inclusion Criteria: * Subjects who the investigator believes can and will comply with the requirements of the protocol or/ and subjects who the investigator believes their parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol * A female ...
GSK Biologicals' HPV vaccine 580299 is an investigational vaccine being studied for the prevention of papillomavirus infections. It is currently in Phase 3 clinical development and is intended for use in females aged 9 to 14 years. The vaccine is being evaluated for its immunogenicity and safety.
GSK Biologicals' HPV vaccine 580299 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is currently in Phase 3 clinical development for the prevention of papillomavirus infections.
GSK Biologicals' HPV vaccine 580299 is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed, evaluating the vaccine's immunogenicity and safety in 9 to 14 year old girls.
GSK Biologicals' HPV vaccine 580299 has one completed Phase 3 clinical trial, identified as NCT01381575. This trial evaluated the immunogenicity and safety of two 2-dose HPV vaccine schedules in 9 to 14 year old girls. The study enrolled 1,447 participants across Canada, Germany, Italy, Taiwan, and Thailand.
GSK Biologicals' HPV vaccine 580299 is a distinct investigational vaccine being developed by GSK plc. It is currently in Phase 3 clinical development for papillomavirus infections. No alternative names for this vaccine have been disclosed in the available information.