Infections, PapillomavirusPhase 3NCT00196924
Human Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio HPV-16/18.
A Phase 3 study testing HPV-16/18 L1/AS04 in people with Infections, Papillomavirus, run by GlaxoSmithKline at 61 sites in 12 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infections, Papillomavirus
- What is being tested?
- HPV-16/18 L1/AS04
- How many people
- 2,067 participants
- Where
- 61 sitesin 12 countries
- Study dates
- Jun 2004to Mar 2006
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
61 sites in 12 countries.
61 sites in 12 countries
Germany28 sites
GSK Investigational Site
Berlin, State of Berlin, 10315
GSK Investigational Site
Berlin, State of Berlin, 10967
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44866
GSK Investigational Site
Bredstedt, Schleswig-Holstein, 25821
GSK Investigational Site
Brunsbüttel, Schleswig-Holstein, 25541
GSK Investigational Site
Bützow, Mecklenburg-Vorpommern, 18246
GSK Investigational Site
Deggingen, Baden-Wurttemberg, 73326
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, 77955
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24939
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24943
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24944
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22307
GSK Investigational Site
Harrislee, Schleswig-Holstein, 24955
GSK Investigational Site
Husum, Schleswig-Holstein, 25813
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694
GSK Investigational Site
Krefeld, North Rhine-Westphalia, 47798
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167
GSK Investigational Site
Niebüll, Schleswig-Holstein, 25899
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18109
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18147
GSK Investigational Site
Tauberbischofsheim, Baden-Wurttemberg, 97941
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290
GSK Investigational Site
Weilheim, Bavaria, 82362
GSK Investigational Site
Weimar, Thuringia, 99425
GSK Investigational Site
Willich, North Rhine-Westphalia, 47877
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38302
GSK Investigational Site
Würzburg, Bavaria, 97070
France11 sites
GSK Investigational Site
Aubevoye, 27940
GSK Investigational Site
Broglie, 27270
GSK Investigational Site
Évreux, 27000
GSK Investigational Site
Luynes, 37230
GSK Investigational Site
Nantes, 44300
GSK Investigational Site
Nogent-le-Roi, 28210
GSK Investigational Site
Paris, 75014
GSK Investigational Site
Pont-de-l'Arche
GSK Investigational Site
Saint-Sébastien-de-Morsent, 27180
GSK Investigational Site
Tours, 37000
GSK Investigational Site
Verneuil-sur-Avre, 27130
Spain6 sites
GSK Investigational Site
Alcora/Castellón, 12110
GSK Investigational Site
Alquerías Del Niño Perdido (Castellón), 12539
GSK Investigational Site
Barcelona, 08037
GSK Investigational Site
Castellon
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Valencia, 46017
Sweden3 sites
GSK Investigational Site
Eskilstuna, SE-631 88
GSK Investigational Site
Linköping, SE-581 85
GSK Investigational Site
Örebro, SE-701 85
Australia2 sites
GSK Investigational Site
North Adelaide, South Australia, 5006
GSK Investigational Site
Perth, Western Australia
Colombia2 sites
GSK Investigational Site
Bogotá, 805
GSK Investigational Site
Bogotá
Czechia2 sites
GSK Investigational Site
Hradec Králové, 500 02
GSK Investigational Site
Pardubice, 532 03
Norway2 sites
GSK Investigational Site
Bergen, 5053
GSK Investigational Site
Oslo, 0370
Taiwan2 sites
GSK Investigational Site
Taipei, 100
GSK Investigational Site
Tao Yuan County, 333
About this study
Official title: 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)
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.
- Conditions
- Infections, Papillomavirus
- Being tested
- HPV-16/18 L1/AS04
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV-16/18 L1/AS04Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infections, PapillomavirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,067 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196924
- Sponsor's protocol ID
- 580299/013
- Status last verified
- Mar 2017
- First submitted
- 13 Sep 2005
- Last updated
- 23 Mar 2017
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
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.
PubMed 41276263Boxus 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.
PubMed 24731816Schwarz 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.
PubMed 22265115Medina 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.
PubMed 20413076