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Blood sampling for antibody determination · 1 trial · 1 indication
A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 19 Enzyme Linked Immunosorbent Assay units per milliliter (EL.U/mL).
A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 18 EL.U/mL.
Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL.
Anti-HPV-18 antibody concentrations are presented as GMCs, expressed in EL.U/mL.
| Arm | Type | Description |
|---|---|---|
| HPV Group | EXPERIMENTAL | Healthy Chinese female subjects, including and above 17 years of age at the time of enrollment, who received all three doses of the Cervarix vaccine in the HPV-058 (NCT00996125) primary study. |
| Name | Type | Description |
|---|---|---|
| Blood sampling for antibody determination | PROCEDURE | In order to assess the persistence of immune responses seven to eight years after the last vaccine dose against HPV-16/18, a blood sample (\~5 mL) will be taken from all the subjects, at Day 1. |
Inclusion Criteria: * Subjects/subject's parents/legally acceptable representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject or subject's parents/LAR(s) prior to performing a...
Blood sampling for antibody determination is used in the context of cervical intraepithelial neoplasia, a precancerous condition of the cervix. It is part of a follow-up extension study evaluating the persistence of immune response to GSK Biologicals' HPV vaccine in healthy Chinese female subjects who previously received three doses of the vaccine.
Blood sampling for antibody determination is developed by GSK plc, which trades under the ticker GSK. The company is conducting a Phase 3 study related to this blood sampling procedure as part of its HPV vaccine research program.
Blood sampling for antibody determination is in Phase 3 clinical development. The associated study, NCT03355820, is a follow-up extension study that has been completed. This phase involves evaluating the persistence of immune response in healthy female subjects.
Blood sampling for antibody determination is associated with clinical trial NCT03355820, titled 'A Follow-up Extension Study to Evaluate the Persistence of Immune Response to GSK Biologicals' HPV Vaccine in Healthy Chinese Female Subjects Who Received Three Doses of the Vaccine in the HPV-058 Study.' This Phase 3 trial enrolled 228 participants and has been completed.
Blood sampling for antibody determination is not the HPV vaccine itself; it is a procedure used to measure antibody levels in the blood. In the context of the clinical trial, it is used to evaluate the immune response to GSK Biologicals' HPV vaccine in healthy female subjects.