Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18
A Phase III, Double-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 Vaccine Compared to Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16 or HPV-18 Cervical Infection and Cervical Neoplasia, Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Females 15-25 Years of Age.
1 other identifier
interventional
18,729
14 countries
138
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 efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2004
Longer than P75 for phase_3
138 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
May 6, 2004
CompletedFirst Submitted
Initial submission to the registry
July 20, 2005
CompletedFirst Posted
Study publicly available on registry
July 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2009
CompletedResults Posted
Study results publicly available
January 20, 2010
CompletedAugust 20, 2018
August 1, 2017
2.5 years
July 20, 2005
November 30, 2009
July 2, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)
CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: 1. DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). 2. Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)
CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in subjects: 1. DNA- and sero-: HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0) 2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
at Month 48
Secondary Outcomes (32)
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3
Number of Subjects Reporting Solicited Local and General Symptoms
Within 7 days after any vaccination
Number of Subjects Reporting Unsolicited Adverse Events
Within 30 days after any vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
Throughout the entire study period (Month 0 to Month 48)
Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)
Throughout the entire study (Month 0 to 48)
- +27 more secondary outcomes
Study Arms (2)
Cervarix Group
EXPERIMENTALSubjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Havrix Group
ACTIVE COMPARATORSubjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Interventions
Intramuscular injection, 3 doses
Eligibility Criteria
You may qualify if:
- A woman whom the investigator believes that she and/or her parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
- A woman between, and including, 15 and 25 years of age at the time of the first vaccination.
- Written informed consent must be obtained from the subject prior to enrollment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legal guardian of the subject and, in addition, the subject should sign and personally date a written informed assent).
- Subject must be free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Subject must have a negative urine pregnancy test.
- Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using adequate contraceptive precautions for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series.
- Has had no more than 6 lifetime sexual partners prior to enrollment. This criterion may not be applicable in subjects less than 18 years of age, according to local regulatory/ethical requirements.
- Subject must have intact cervix.
You may not qualify if:
- Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study.
- A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Months 0-8).
- Previous administration of components of the investigational vaccine.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0-29) each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
- Previous vaccination against human papillomavirus (HPV).
- History of vaccination against Hepatitis A or a known clinical history of Hepatitis A disease.
- History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test.
- Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
- History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines.
- Hypersensitivity to latex.
- Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
- History of chronic condition(s) requiring treatment.
- Received immunoglobulins and/or blood product within 90 days preceding enrollment. Enrollment will be deferred until the subject is outside of specified window.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (138)
GSK Investigational Site
Birmingham, Alabama, 35233, United States
GSK Investigational Site
Fountain Valley, California, 92708, United States
GSK Investigational Site
San Diego, California, 92108, United States
GSK Investigational Site
San Francisco, California, 94115, United States
GSK Investigational Site
Boulder, Colorado, 80303, United States
GSK Investigational Site
Boulder, Colorado, 80304, United States
GSK Investigational Site
Denver, Colorado, 80218, United States
GSK Investigational Site
Louisville, Colorado, 80027, United States
GSK Investigational Site
Clearwater, Florida, 33759, United States
GSK Investigational Site
Coral Gables, Florida, 33134, United States
GSK Investigational Site
Miami, Florida, 33136, United States
GSK Investigational Site
West Palm Beach, Florida, 33409, United States
GSK Investigational Site
Augusta, Georgia, 30912, United States
GSK Investigational Site
Honolulu, Hawaii, 96826, United States
GSK Investigational Site
Iowa City, Iowa, 52242, United States
GSK Investigational Site
Arkansas City, Kansas, 67005, United States
GSK Investigational Site
Wichita, Kansas, 67205, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Bardstown, Kentucky, 40004, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
Minneapolis, Minnesota, 55455, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Lebanon, New Hampshire, 03756, United States
GSK Investigational Site
Morristown, New Jersey, 07960, United States
GSK Investigational Site
Albuquerque, New Mexico, 87131, United States
GSK Investigational Site
New York, New York, 10029, United States
GSK Investigational Site
Poughkeepsie, New York, 12601, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27514, United States
GSK Investigational Site
New Bern, North Carolina, 28562, United States
GSK Investigational Site
Cleveland, Ohio, 44109, United States
GSK Investigational Site
Tulsa, Oklahoma, 74105, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Carnegie, Pennsylvania, 15106, United States
GSK Investigational Site
Erie, Pennsylvania, 16502, United States
GSK Investigational Site
Erie, Pennsylvania, 16505, United States
GSK Investigational Site
Erie, Pennsylvania, 16507, United States
GSK Investigational Site
Erie, Pennsylvania, 16508, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19114, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Houston, Texas, 77004, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Webster, Texas, 77598, United States
GSK Investigational Site
Salt Lake City, Utah, 84120, United States
GSK Investigational Site
Charlottesville, Virginia, 22903, United States
GSK Investigational Site
Spokane, Washington, 99202, United States
GSK Investigational Site
Spokane, Washington, 99218, United States
GSK Investigational Site
Vancouver, Washington, 98664, United States
GSK Investigational Site
Wenatchee, Washington, 98801, United States
GSK Investigational Site
Sydney, New South Wales, 4001, Australia
GSK Investigational Site
Adelaide, South Australia, 5000, Australia
GSK Investigational Site
Hobart, Tasmania, Australia
GSK Investigational Site
Carlton, Melbourne, Victoria, Australia
GSK Investigational Site
Melbourne, Victoria, Australia
GSK Investigational Site
Perth, Western Australia, Australia
GSK Investigational Site
Brussels, 1090, Belgium
GSK Investigational Site
Edegem, 2650, Belgium
GSK Investigational Site
Leuven, 3000, Belgium
GSK Investigational Site
Curitiba, Paraná, 80069-900, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
GSK Investigational Site
Campinas, São Paulo, Brazil
GSK Investigational Site
Edmonton, Alberta, T6G 2C8, Canada
GSK Investigational Site
Langley, British Columbia, V3A 4H9, Canada
GSK Investigational Site
Winnipeg, Manitoba, R3E 0J9, Canada
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1E 2C2, Canada
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2, Canada
GSK Investigational Site
Oshawa, Ontario, L1H 1C2, Canada
GSK Investigational Site
Ottawa, Ontario, K1S 1C2, Canada
GSK Investigational Site
Toronto, Ontario, M4N 3M5, Canada
GSK Investigational Site
Waterloo, Ontario, N2J 1C4, Canada
GSK Investigational Site
Beauport, Quebec, G1E 7G9, Canada
GSK Investigational Site
Montreal, Quebec, H3T 1E2, Canada
GSK Investigational Site
Espoo, 02100, Finland
GSK Investigational Site
Helsinki, 00100, Finland
GSK Investigational Site
Helsinki, 00610, Finland
GSK Investigational Site
Jarvenpaa, 04400, Finland
GSK Investigational Site
Jyväskylä, 40100, Finland
GSK Investigational Site
Kerava, 04250, Finland
GSK Investigational Site
Kotka, 48100, Finland
GSK Investigational Site
Kouvola, 45100, Finland
GSK Investigational Site
Kuopio, 70100, Finland
GSK Investigational Site
Lahti, 15110, Finland
GSK Investigational Site
Lappeenranta, 53100, Finland
GSK Investigational Site
Mikkeli, 50100, Finland
GSK Investigational Site
Oulu, 90220, Finland
GSK Investigational Site
Pori, 28100, Finland
GSK Investigational Site
Rauma, 26100, Finland
GSK Investigational Site
Seinäjoki, 60100, Finland
GSK Investigational Site
Tampere, 33100, Finland
GSK Investigational Site
Turku, 20520, Finland
GSK Investigational Site
Vaasa, 65100, Finland
GSK Investigational Site
Karlsruhe, Baden-Wurttemberg, 76199, Germany
GSK Investigational Site
Ravensburg, Baden-Wurttemberg, 88212, Germany
GSK Investigational Site
Rheinstetten, Baden-Wurttemberg, 76287, Germany
GSK Investigational Site
Munich, Bavaria, 80331, Germany
GSK Investigational Site
Munich, Bavaria, 80637, Germany
GSK Investigational Site
Würzburg, Bavaria, 97070, Germany
GSK Investigational Site
Dietzenbach, Hesse, 63128, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60439, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 65936, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30657, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116, Germany
GSK Investigational Site
Leipzig, Saxony, 04109, Germany
GSK Investigational Site
Nordhausen, Thuringia, 99734, Germany
GSK Investigational Site
Berlin, 10119, Germany
GSK Investigational Site
Berlin, 13086, Germany
GSK Investigational Site
Hamburg, 20246, Germany
GSK Investigational Site
Hamburg, 22143, Germany
GSK Investigational Site
Hamburg, 22149, Germany
GSK Investigational Site
Hamburg, 22159, Germany
GSK Investigational Site
Modena, Emilia-Romagna, 41150, Italy
GSK Investigational Site
Milan, Lombardy, 20122, Italy
GSK Investigational Site
Cuenavaca, Morelos, 62430, Mexico
GSK Investigational Site
Cavite, Philippines
GSK Investigational Site
Laguna, Philippines
GSK Investigational Site
Las Piñas, Philippines
GSK Investigational Site
Los Banos, Laguna, 4027, Philippines
GSK Investigational Site
Makati City, 1231, Philippines
GSK Investigational Site
Manila, 1000, Philippines
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
L'Hospitalet de Llobregat, 08907, Spain
GSK Investigational Site
Madrid, 28009, Spain
GSK Investigational Site
Marid, 28040, Spain
GSK Investigational Site
Móstoles, 28935, Spain
GSK Investigational Site
Taipei, 100, Taiwan
GSK Investigational Site
Taipei, 112, Taiwan
GSK Investigational Site
Taipei, 114, Taiwan
GSK Investigational Site
Bangkok, 10330, Thailand
GSK Investigational Site
Bangkok, 10400, Thailand
GSK Investigational Site
Bangkok, 10700, Thailand
GSK Investigational Site
Aberdeen, AB25 2ZN, United Kingdom
GSK Investigational Site
London, SW17 0QT, United Kingdom
GSK Investigational Site
London, W1P 1LB, United Kingdom
GSK Investigational Site
Manchester, M13 9WL, United Kingdom
GSK Investigational Site
Manchester, M15 6SX, United Kingdom
GSK Investigational Site
Waterloo, Liverpool, L22 0LG, United Kingdom
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PMID: 25540273DERIVEDCastellsague X, Naud P, Chow SN, Wheeler CM, Germar MJ, Lehtinen M, Paavonen J, Jaisamrarn U, Garland SM, Salmeron J, Apter D, Kitchener H, Teixeira JC, Skinner SR, Limson G, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, de Carvalho NS, Peters K, Tjalma WA, Safaeian M, Raillard A, Descamps D, Struyf F, Dubin G, Rosillon D, Baril L. Risk of newly detected infections and cervical abnormalities in women seropositive for naturally acquired human papillomavirus type 16/18 antibodies: analysis of the control arm of PATRICIA. J Infect Dis. 2014 Aug 15;210(4):517-34. doi: 10.1093/infdis/jiu139. Epub 2014 Mar 8.
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Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2005
First Posted
July 22, 2005
Study Start
May 6, 2004
Primary Completion
November 3, 2006
Study Completion
November 26, 2009
Last Updated
August 20, 2018
Results First Posted
January 20, 2010
Record last verified: 2017-08
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.