Clinical trial · Interventional
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects.
Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of a HPV Vaccine (GSK 580299) in Healthy Female Subjects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals with objectives \& outcome measures of the extension phase from Month 60 to Month 120. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The objectives \& outcome measures of the extension phase up to Month 48 are presented in a separate protocol posting (NCT00316706).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infections, Papillomavirus | — | UNRESOLVED | — |
| Papillomavirus Vaccines | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cervarix Group
- description
- Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
- interventionNames
- Procedure: Blood sampling
Primary outcomes (12)
- measure
- Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
- timeFrame
- At Month 60
- description
- Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer \< 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer \>= 8 or 7 EL.U/mL prior to vaccination.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 15 Years
- Maximum age
- 24 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects who the investigator believes that they and/or their parents or legally acceptable representative (LAR) can and will comply with the requirements of the protocol should be enrolled in the study. * A female enrolled in the immunogenicity subset of study 580299-013, who received three doses of HPV vaccine and participated in the extension study of 580299-013. * Written informed assent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative of the subject. Exclusion Criteria: * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period. * Administration or planned administration of any HPV vaccine, other than the vaccine administered in study 580299-013. * Chronic administration of immunosuppressants or other immune-modifying drugs occurring within the three months preceding study entry. * Administration of immunoglobulins and/or any blood products occurring within the three months preceding study entry.
References
Publications (2)
- BACKGROUNDSchwarz TF, Huang LM, Lin TY, Wittermann C, Panzer F, Valencia A, Suryakiran PV, Lin L, Descamps D. Long-term immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in 10- to 14-year-old girls: open 6-year follow-up of an initial observer-blinded, randomized trial. Pediatr Infect Dis J. 2014 Dec;33(12):1255-61. doi: 10.1097/INF.0000000000000460. PMID 24978856
- BACKGROUNDSchwarz TF, Huang LM, Valencia A, Panzer F, Chiu CH, Decreux A, Poncelet S, Karkada N, Folschweiller N, Lin L, Dubin G, Struyf F. A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years. Hum Vaccin Immunother. 2019;15(7-8):1970-1979. doi: 10.1080/21645515.2019.1625644. Epub 2019 Jul 17. PMID 31268383