Human Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio HPV-16/18.
Evaluate the Safety and Immunogenicity of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to a 0,1,6 Month Schedule in Healthy Female Subjects (10 - 14 Years)
1 other identifier
interventional
2,067
12 countries
61
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2004
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedMarch 23, 2017
March 1, 2017
1.7 years
September 13, 2005
March 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.
Secondary Outcomes (1)
Safety of HPV vaccine in entire study period. Vaccine immunogenicity.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (61)
GSK Investigational Site
North Adelaide, South Australia, 5006, Australia
GSK Investigational Site
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, 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
Related Publications (4)
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.
PMID: 41276263DERIVEDBoxus 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.
PMID: 24731816DERIVEDSchwarz 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.
PMID: 22265115DERIVEDMedina 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.
PMID: 20413076DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
June 1, 2004
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
March 23, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.