Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the safety and immunogenicity of GSK Biologicals HPV-16/18 vaccine over 12 months, in pre-teen and adolescent women of 10-14 years of age at study start. Approximately 2000 study subjects will receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV-16/18 L1/AS04 | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of HPV vaccine in entire study period. Vaccine immunogenicity. |
Not provided
Inclusion Criteria:
A woman between, and including, 10 and 14 years of age at the time of the first vaccination.
Written informed consent from the subject prior to enrolment. Subject must be free of obvious health problems. Subject must have negative urine pregnancy test.
Exclusion Criteria:
Pregnant or breastfeeding. Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality.
History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease.
Previous vaccination against human papillomavirus (HPV).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | North Adelaide | South Australia | 5006 | Australia | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41276263 | Derived | Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2. | |
| 24731816 |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 580299/013 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Perth |
| Western Australia |
| Australia |
| GSK Investigational Site | Bogotá | 805 | Colombia |
| GSK Investigational Site | Bogotá | Colombia |
| GSK Investigational Site | Hradec Králové | 500 02 | Czechia |
| GSK Investigational Site | Pardubice | 532 03 | Czechia |
| GSK Investigational Site | Aubevoye | 27940 | France |
| GSK Investigational Site | Broglie | 27270 | France |
| GSK Investigational Site | Évreux | 27000 | France |
| GSK Investigational Site | Luynes | 37230 | France |
| GSK Investigational Site | Nantes | 44300 | France |
| GSK Investigational Site | Nogent-le-Roi | 28210 | France |
| GSK Investigational Site | Paris | 75014 | France |
| GSK Investigational Site | Pont-de-l'Arche | France |
| GSK Investigational Site | Saint-Sébastien-de-Morsent | 27180 | France |
| GSK Investigational Site | Tours | 37000 | France |
| GSK Investigational Site | Verneuil-sur-Avre | 27130 | France |
| GSK Investigational Site | Deggingen | Baden-Wurttemberg | 73326 | Germany |
| GSK Investigational Site | Ettenheim | Baden-Wurttemberg | 77955 | Germany |
| GSK Investigational Site | Kehl | Baden-Wurttemberg | 77694 | Germany |
| GSK Investigational Site | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| GSK Investigational Site | Tauberbischofsheim | Baden-Wurttemberg | 97941 | Germany |
| GSK Investigational Site | Weilheim | Bavaria | 82362 | Germany |
| GSK Investigational Site | Würzburg | Bavaria | 97070 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 22307 | Germany |
| GSK Investigational Site | Wolfenbüttel | Lower Saxony | 38302 | Germany |
| GSK Investigational Site | Bützow | Mecklenburg-Vorpommern | 18246 | Germany |
| GSK Investigational Site | Rostock | Mecklenburg-Vorpommern | 18109 | Germany |
| GSK Investigational Site | Rostock | Mecklenburg-Vorpommern | 18147 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44866 | Germany |
| GSK Investigational Site | Krefeld | North Rhine-Westphalia | 47798 | Germany |
| GSK Investigational Site | Willich | North Rhine-Westphalia | 47877 | Germany |
| GSK Investigational Site | Trier | Rhineland-Palatinate | 54290 | Germany |
| GSK Investigational Site | Bredstedt | Schleswig-Holstein | 25821 | Germany |
| GSK Investigational Site | Brunsbüttel | Schleswig-Holstein | 25541 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24937 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24939 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24943 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24944 | Germany |
| GSK Investigational Site | Harrislee | Schleswig-Holstein | 24955 | Germany |
| GSK Investigational Site | Husum | Schleswig-Holstein | 25813 | Germany |
| GSK Investigational Site | Niebüll | Schleswig-Holstein | 25899 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10315 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10967 | Germany |
| GSK Investigational Site | Weimar | Thuringia | 99425 | Germany |
| GSK Investigational Site | Comayagüela | Honduras |
| GSK Investigational Site | Bergen | 5053 | Norway |
| GSK Investigational Site | Oslo | 0370 | Norway |
| GSK Investigational Site | Ciudad de Panama - La Chorrera | Panama |
| GSK Investigational Site | Seoul | 133--792 | South Korea |
| GSK Investigational Site | Alcora/Castellón | 12110 | Spain |
| GSK Investigational Site | Alquerías Del Niño Perdido (Castellón) | 12539 | Spain |
| GSK Investigational Site | Barcelona | 08037 | Spain |
| GSK Investigational Site | Castellon | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Valencia | 46017 | Spain |
| GSK Investigational Site | Eskilstuna | SE-631 88 | Sweden |
| GSK Investigational Site | Linköping | SE-581 85 | Sweden |
| GSK Investigational Site | Örebro | SE-701 85 | Sweden |
| GSK Investigational Site | Taipei | 100 | Taiwan |
| GSK Investigational Site | Tao Yuan County | 333 | Taiwan |
| Derived |
| Boxus M, Lockman L, Fochesato M, Lorin C, Thomas F, Giannini SL. Antibody avidity measurements in recipients of Cervarix vaccine following a two-dose schedule or a three-dose schedule. Vaccine. 2014 May 30;32(26):3232-6. doi: 10.1016/j.vaccine.2014.04.005. Epub 2014 Apr 13. |
| 22265115 | Derived | Schwarz TF, Huang LM, Medina DM, Valencia A, Lin TY, Behre U, Catteau G, Thomas F, Descamps D. Four-year follow-up of the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine when administered to adolescent girls aged 10-14 years. J Adolesc Health. 2012 Feb;50(2):187-94. doi: 10.1016/j.jadohealth.2011.11.004. |
| 20413076 | Derived | Medina DM, Valencia A, de Velasquez A, Huang LM, Prymula R, Garcia-Sicilia J, Rombo L, David MP, Descamps D, Hardt K, Dubin G; HPV-013 Study Group. Safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine: a randomized, controlled trial in adolescent girls. J Adolesc Health. 2010 May;46(5):414-21. doi: 10.1016/j.jadohealth.2010.02.006. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 580299/013 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 580299/013 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 580299/013 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 580299/013 are summarised with studies 104896 (M18), 104902 (M24), 104904 (M36) and 104918 (M48) on the GSK Clinical Study Register. |
| 580299/013 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 580299/013 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 580299/013 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided