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Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GSK Biologicals HPV-16/18
This study is ongoing, but not recruiting participants.
First Received: July 20, 2005   Last Updated: September 17, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00122681
  Purpose

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.


Condition Intervention Phase
Human Papillomavirus (HPV) Infection
Cervical Neoplasia
 Biological: GSK Biologicals' Human Papillomavirus vaccine
Biological: Investigational Hepatitis A vaccine
 Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy of GSK Bio HPV Vaccine (580299) vs Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16/18 Cervical Infection & Cervical Neoplasia, Administered IM According to 0,1,6 Month Schedule in Healthy Females (15-25 y)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hepatitis Hepatitis A
Drug Information available for: Hepatitis A Vaccines
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Histopathologically confirmed CIN2+ associated with HPV-16 or HPV-18 cervical infection detected within the lesional component of the cervical tissue specimen, overall and stratified according to initial (M0) HPV-16 or 18 serostatus. [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence, intensity, relationship to vaccination & resulting school or work absenteeism of any sol local or gen symptoms & stratified by initial(M0) HPV-16/18 DNA status & acc to HPV-16 or 18 serostatus in a subset of subjects from selected study sites [ Time Frame: Within 7 days after each vaccination dose ] [ Designated as safety issue: No ]
  • Occurrence, intensity, relationship to vaccination & resulting school or work absenteeism of any unsolicited symptoms & stratified by initial (M0) HPV-16/18 DNA status & according to HPV-16/18 serostatus in a subset of subjects from selected study sites [ Time Frame: Within 30 days after any vaccination ] [ Designated as safety issue: No ]
  • Occurrence of SAEs stratified by initial (Month 0) HPV-16/18 DNA status and according to HPV-16 or 18 serostatus in all subjects [ Time Frame: Throughout the entire study period (Month 0 to Month 48) ] [ Designated as safety issue: No ]
  • Occurrence of new onset chronic disease stratified by initial (Month 0) HPV-16/18 DNA status and according to HPV 16 or 18 serostatus in all subjects [ Time Frame: Throughout the entire study (Month 0 to 48) ] [ Designated as safety issue: No ]
  • Occurrence of medically significant conditions stratified by initial (Month 0) HPV-16/18 DNA status and according to HPV-16 or 18 serostatus [ Time Frame: Throughout entire study period (Month 0 to Month 48) ] [ Designated as safety issue: No ]
  • Outcome of all pregnancies, overall and stratified by initial (Month 0) HPV-16/18 DNA status and according to HPV-16 or -18 serostatus [ Time Frame: Throughout the entire study period (Month 0 to Month 48) ] [ Designated as safety issue: No ]
  • Persistent infection (12M definition) with HPV-16 or HPV-18, overall and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus. [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • Persistent infection (6M definition) with HPV-16 or HPV-18, overall and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus. [ Time Frame: At the time of analysis ]
  • Persistent infection (6M definition) with oncogenic HPV types. [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • Histopathologically confirmed CIN2+ associated with oncogenic HPV types detected within the lesional component of the cervical tissue specimen. [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • Histopathologically confirmed CIN1+ associated with HPV-16 or HPV-18 detected within the lesional component of the cervical tissue specimen, overall and stratified according to initial (Month 0) HPV-16 or 18 serostatus. [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • Histopathologically confirmed CIN1+ associated with oncogenic HPV types detected within the lesional component of the cervical tissue specimen. [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • HPV-16 and HPV-18 ELISA titers and seroconversion (in the immunogenicity subset according to initial (Month 0) HPV-16 or HPV-18 serostatus [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • HPV-16 and HPV-18 seroconversion and titers (ELISA & V5/J4 monoclonal inhibition test) in vaccine recipients with breakthrough HPV-16 and/or HPV-18 infections & associated neoplasias compared with selected non-cases [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]

Estimated Enrollment: 18673
Study Start Date: May 2004
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group B: Active Comparator Biological: Investigational Hepatitis A vaccine
Intramuscular injection, 3 doses
Group A: Experimental Biological: GSK Biologicals' Human Papillomavirus vaccine
Intramuscular injection, 3 doses

Detailed Description:

NOTE: Some 178 centers participate in this study. Given that the recruitment is completed, the researchers have listed one center per country in this website. If required, further details of centers available on request.

  Eligibility

Ages Eligible for Study:   15 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Acute disease at the time of enrolment.
  • Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic exam cannot be performed. Enrollment will be deferred until condition is resolved according to investigator's medical judgement.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122681

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35233
United States, California
GSK Investigational Site
San Diego, California, United States, 92108
GSK Investigational Site
San Francisco, California, United States, 94115
GSK Investigational Site
Fountain Valley, California, United States, 92708
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80218
GSK Investigational Site
Boulder, Colorado, United States, 80303
GSK Investigational Site
Louisville, Colorado, United States, 80027
GSK Investigational Site
Boulder, Colorado, United States, 80304
United States, Florida
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
GSK Investigational Site
Clearwater, Florida, United States, 33759
GSK Investigational Site
Miami, Florida, United States, 33136
GSK Investigational Site
Coral Gables, Florida, United States, 33134
United States, Georgia
GSK Investigational Site
Augusta, Georgia, United States, 30912
United States, Hawaii
GSK Investigational Site
Honolulu, Hawaii, United States, 96826
United States, Iowa
GSK Investigational Site
Iowa City, Iowa, United States, 52242
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67207
GSK Investigational Site
Arkansas City, Kansas, United States, 67005
GSK Investigational Site
Wichita, Kansas, United States, 67205
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40202
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55455
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68131
United States, New Hampshire
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
GSK Investigational Site
Morristown, New Jersey, United States, 07960
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
United States, New York
GSK Investigational Site
Poughkeepsie, New York, United States, 12601
GSK Investigational Site
New York, New York, United States, 10029
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27514
GSK Investigational Site
New Bern, North Carolina, United States, 28562
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44109
United States, Oklahoma
GSK Investigational Site
Tulsa, Oklahoma, United States, 74105
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
GSK Investigational Site
Erie, Pennsylvania, United States, 16502
GSK Investigational Site
Erie, Pennsylvania, United States, 16508
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19114
GSK Investigational Site
Erie, Pennsylvania, United States, 16502
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
Houston, Texas, United States, 77004
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
Webster, Texas, United States, 77598
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84120
United States, Virginia
GSK Investigational Site
Charlottesville, Virginia, United States, 22908
United States, Washington
GSK Investigational Site
Wenatchee, Washington, United States, 98801
GSK Investigational Site
Vancouver, Washington, United States, 98664
GSK Investigational Site
Spokane, Washington, United States, 99218
GSK Investigational Site
Spokane, Washington, United States, 99202
Australia, New South Wales
GSK Investigational Site
Sydney, New South Wales, Australia, 4001
Australia, South Australia
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Australia, Tasmania
GSK Investigational Site
Hobart, Tasmania, Australia
Australia, Victoria
GSK Investigational Site
Carlton, Melbourne, Victoria, Australia
GSK Investigational Site
Melbourne, Victoria, Australia
Australia, Western Australia
GSK Investigational Site
Perth, Western Australia, Australia
Belgium
GSK Investigational Site
Brussels, Belgium, 1090
GSK Investigational Site
Edegem, Belgium, 2650
GSK Investigational Site
Leuven, Belgium, 3000
Brazil, Paraná
GSK Investigational Site
Curitiba, Paraná, Brazil, 80069-900
Brazil, Rio Grande Do Sul
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Brazil, São Paulo
GSK Investigational Site
Campinas, São Paulo, Brazil
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
GSK Investigational Site
Langley, British Columbia, Canada, V3A 4H9
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3E 0J9
Canada, Newfoundland and Labrador
GSK Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1E 2C2
Canada, Nova Scotia
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
GSK Investigational Site
Oshawa, Ontario, Canada, L1H 1C2
GSK Investigational Site
Ottawa, Ontario, Canada, K1S 1C2
GSK Investigational Site
Waterloo, Ontario, Canada, N2J 1C4
Canada, Quebec
GSK Investigational Site
Beauport, Quebec, Canada, G1E 7G9
GSK Investigational Site
Gatineau, Quebec, Canada, J8Y 6S8
GSK Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Finland
GSK Investigational Site
Lappeenranta, Finland, 53100
GSK Investigational Site
Kuopio, Finland, 70100
GSK Investigational Site
Jyvaskyla, Finland, 40100
GSK Investigational Site
Kotka, Finland, 48100
GSK Investigational Site
Mikkeli, Finland, 50100
GSK Investigational Site
Vaasa, Finland, 65100
GSK Investigational Site
Pori, Finland, 28100
GSK Investigational Site
Seinajoki, Finland, 60100
GSK Investigational Site
Helsinki, Finland, 00100
GSK Investigational Site
Helsinki, Finland, 00610
GSK Investigational Site
Tampere, Finland, 33100
GSK Investigational Site
Espoo, Finland, 02100
GSK Investigational Site
Jarvenpaa, Finland, 04400
GSK Investigational Site
Turku, Finland, 20520
GSK Investigational Site
Rauma, Finland, 26100
GSK Investigational Site
Oulu, Finland, 90220
GSK Investigational Site
Lahti, Finland, 15110
GSK Investigational Site
Kouvola, Finland, 45100
Germany
GSK Investigational Site
Berlin, Germany, 10119
GSK Investigational Site
Berlin, Germany, 13086
GSK Investigational Site
Hamburg, Germany, 22159
GSK Investigational Site
Hamburg, Germany, 20246
GSK Investigational Site
Hamburg, Germany, 22149
Germany, Baden-Wuerttemberg
GSK Investigational Site
Rheinstetten, Baden-Wuerttemberg, Germany, 76287
GSK Investigational Site
Karlsruhe, Baden-Wuerttemberg, Germany, 76199
GSK Investigational Site
Ravensburg, Baden-Wuerttemberg, Germany, 88212
Germany, Bayern
GSK Investigational Site
Muenchen, Bayern, Germany, 80637
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
Germany, Hessen
GSK Investigational Site
Frankfurt, Hessen, Germany, 60439
Germany, Niedersachsen
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30657
Germany, Rheinland-Pfalz
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
Germany, Sachsen
GSK Investigational Site
Leipzig, Sachsen, Germany, 04109
Germany, Thueringen
GSK Investigational Site
Nordhausen, Thueringen, Germany, 99734
Italy, Emilia-Romagna
GSK Investigational Site
Modena, Emilia-Romagna, Italy, 41150
Italy, Lombardia
GSK Investigational Site
Milano, Lombardia, Italy, 20122
Mexico, Morelos
GSK Investigational Site
Cuenavaca, Morelos, Mexico, 62430
Philippines
GSK Investigational Site
Laguna, Philippines
GSK Investigational Site
Cavite, Philippines
GSK Investigational Site
Las Pinas City, Philippines
GSK Investigational Site
Los Banos, Laguna, Philippines, 4027
GSK Investigational Site
Manila, Philippines, 1000
GSK Investigational Site
Makati City, Philippines, 1231
Spain
GSK Investigational Site
Madrid, Spain, 28009
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
L'Hospitalet de Llobregat, Spain, 08907
GSK Investigational Site
Marid, Spain, 28040
GSK Investigational Site
Móstoles, Spain, 28935
Taiwan
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taipei, Taiwan, 114
GSK Investigational Site
Taipei, Taiwan, 112
Thailand
GSK Investigational Site
Bangkok, Thailand, 10400
GSK Investigational Site
Bangkok, Thailand, 10330
GSK Investigational Site
Bangkok, Thailand, 10700
United Kingdom
GSK Investigational Site
London, United Kingdom, SW17 0QT
GSK Investigational Site
Waterloo, Liverpool, United Kingdom, L22 0LG
GSK Investigational Site
London, United Kingdom, W1P 1LB
GSK Investigational Site
Manchester, United Kingdom, M13 9WL
GSK Investigational Site
Manchester, United Kingdom, M15 6SX
United Kingdom, Aberdeenshire
GSK Investigational Site
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Paavonen J, Naud P, Salmerón J, Wheeler CM, Chow SN, Apter D, Kitchener H, Castellsague X, Teixeira JC, Skinner SR, Hedrick J, Jaisamrarn U, Limson G, Garland S, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, Jenkins D, Hardt K, Zahaf T, Descamps D, Struyf F, Lehtinen M, Dubin G; HPV PATRICIA Study Group; Greenacre M. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet. 2009 Jul 25;374(9686):301-14. Epub 2009 Jul 6.
Paavonen J, Jenkins D, Bosch FX, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter DL, Kitchener HC, Castellsague X, de Carvalho NS, Skinner SR, Harper DM, Hedrick JA, Jaisamrarn U, Limson GA, Dionne M, Quint W, Spiessens B, Peeters P, Struyf F, Wieting SL, Lehtinen MO, Dubin G; HPV PATRICIA study group. Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial. Lancet. 2007 Jun 30;369(9580):2161-70.

Responsible Party: GSK ( Study Director )
Study ID Numbers: 580299/008
Study First Received: July 20, 2005
Last Updated: September 17, 2009
ClinicalTrials.gov Identifier: NCT00122681     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Communicable Diseases
Neoplasms
Infection

ClinicalTrials.gov processed this record on November 27, 2009



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