Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18

NCT ID: NCT00122681

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 18729 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-06
• Study Completion Date: 2009-11-26

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.

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.

Conditions

Infections, Papillomavirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Cervarix Group

Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.

Group Type: EXPERIMENTAL

Cervarix™

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

Havrix Group

Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.

Group Type: ACTIVE_COMPARATOR

Havrix™-based investigational formulation

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

Interventions

Cervarix™

Intramuscular injection, 3 doses

Intervention Type: BIOLOGICAL

Havrix™-based investigational formulation

Intramuscular injection, 3 doses

Intervention Type: BIOLOGICAL

Other Intervention Names

GSK Biologicals HPV 16/18 VLP/AS04 vaccine

Eligibility 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Fountain Valley, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Boulder, Colorado, United States

GSK Investigational Site

Boulder, Colorado, United States

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Louisville, Colorado, United States

GSK Investigational Site

Clearwater, Florida, United States

GSK Investigational Site

Coral Gables, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

West Palm Beach, Florida, United States

GSK Investigational Site

Augusta, Georgia, United States

GSK Investigational Site

Honolulu, Hawaii, United States

GSK Investigational Site

Iowa City, Iowa, United States

GSK Investigational Site

Arkansas City, Kansas, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Bardstown, Kentucky, United States

GSK Investigational Site

Louisville, Kentucky, United States

GSK Investigational Site

Minneapolis, Minnesota, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Lebanon, New Hampshire, United States

GSK Investigational Site

Morristown, New Jersey, United States

GSK Investigational Site

Albuquerque, New Mexico, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Poughkeepsie, New York, United States

GSK Investigational Site

Chapel Hill, North Carolina, United States

GSK Investigational Site

New Bern, North Carolina, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Tulsa, Oklahoma, United States

GSK Investigational Site

Portland, Oregon, United States

GSK Investigational Site

Carnegie, Pennsylvania, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Webster, Texas, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Charlottesville, Virginia, United States

GSK Investigational Site

Spokane, Washington, United States

GSK Investigational Site

Spokane, Washington, United States

GSK Investigational Site

Vancouver, Washington, United States

GSK Investigational Site

Wenatchee, Washington, United States

GSK Investigational Site

Sydney, New South Wales, Australia

GSK Investigational Site

Adelaide, South Australia, 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, , Belgium

GSK Investigational Site

Edegem, , Belgium

GSK Investigational Site

Leuven, , Belgium

GSK Investigational Site

Curitiba, Paraná, Brazil

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

GSK Investigational Site

Campinas, São Paulo, Brazil

GSK Investigational Site

Edmonton, Alberta, Canada

GSK Investigational Site

Langley, British Columbia, Canada

GSK Investigational Site

Winnipeg, Manitoba, Canada

GSK Investigational Site

St. John's, Newfoundland and Labrador, Canada

GSK Investigational Site

Truro, Nova Scotia, Canada

GSK Investigational Site

Oshawa, Ontario, Canada

GSK Investigational Site

Ottawa, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Waterloo, Ontario, Canada

GSK Investigational Site

Beauport, Quebec, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Espoo, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Järvenpää, , Finland

GSK Investigational Site

Jyväskylä, , Finland

GSK Investigational Site

Kerava, , Finland

GSK Investigational Site

Kotka, , Finland

GSK Investigational Site

Kouvola, , Finland

GSK Investigational Site

Kuopio, , Finland

GSK Investigational Site

Lahti, , Finland

GSK Investigational Site

Lappeenranta, , Finland

GSK Investigational Site

Mikkeli, , Finland

GSK Investigational Site

Oulu, , Finland

GSK Investigational Site

Pori, , Finland

GSK Investigational Site

Rauma, , Finland

GSK Investigational Site

Seinäjoki, , Finland

GSK Investigational Site

Tampere, , Finland

GSK Investigational Site

Turku, , Finland

GSK Investigational Site

Vaasa, , Finland

GSK Investigational Site

Karlsruhe, Baden-Wurttemberg, Germany

GSK Investigational Site

Ravensburg, Baden-Wurttemberg, Germany

GSK Investigational Site

Rheinstetten, Baden-Wurttemberg, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Würzburg, Bavaria, Germany

GSK Investigational Site

Dietzenbach, Hesse, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Nordhausen, Thuringia, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Modena, Emilia-Romagna, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Cuenavaca, Morelos, Mexico

GSK Investigational Site

Cavite, , Philippines

GSK Investigational Site

Laguna, , Philippines

GSK Investigational Site

Las Piñas, , Philippines

GSK Investigational Site

Los Banos, Laguna, , Philippines

GSK Investigational Site

Makati City, , Philippines

GSK Investigational Site

Manila, , Philippines

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

L'Hospitalet de Llobregat, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Marid, , Spain

GSK Investigational Site

Móstoles, , Spain

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Bangkok, , Thailand

GSK Investigational Site

Bangkok, , Thailand

GSK Investigational Site

Bangkok, , Thailand

GSK Investigational Site

Aberdeen, , United Kingdom

GSK Investigational Site

London, , United Kingdom

GSK Investigational Site

London, , United Kingdom

GSK Investigational Site

Manchester, , United Kingdom

GSK Investigational Site

Manchester, , United Kingdom

GSK Investigational Site

Waterloo, Liverpool, , United Kingdom

Countries

United States; Australia; Belgium; Brazil; Canada; Finland; Germany; Italy; Mexico; Philippines; Spain; Taiwan; Thailand; United Kingdom

References

Lehtinen M, Lagheden C, Luostarinen T, Eriksson T, Apter D, Bly A, Gray P, Harjula K, Heikkila K, Hokkanen M, Karttunen H, Kuortti M, Nieminen P, Nummela M, Paavonen J, Palmroth J, Petaja T, Pukkala E, Soderlund-Strand A, Veivo U, Dillner J. Human papillomavirus vaccine efficacy against invasive, HPV-positive cancers: population-based follow-up of a cluster-randomised trial. BMJ Open. 2021 Dec 30;11(12):e050669. doi: 10.1136/bmjopen-2021-050669.

Reference Type: DERIVED

PMID: 35149535 (View on PubMed)

Welby S, Rosillon D, Feng Y, Borys D. Progression from human papillomavirus (HPV) infection to cervical lesion or clearance in women (18-25 years): Natural history study in the control arm subjects of AS04-HPV-16/18 vaccine efficacy study in China between 2008 and 2016. Expert Rev Vaccines. 2022 Mar;21(3):407-413. doi: 10.1080/14760584.2022.2021077. Epub 2022 Jan 24.

Reference Type: DERIVED

PMID: 34939897 (View on PubMed)

Adhikari I, Eriksson T, Luostarinen T, Apter D, Lehtinen M. Is the risk of cervical atypia associated with the interval between menarche and the start of sexual activity? A population-based cohort study. BMJ Open. 2019 Sep 11;9(9):e030091. doi: 10.1136/bmjopen-2019-030091.

Reference Type: DERIVED

PMID: 31511286 (View on PubMed)

Castellsague X, Paavonen J, Jaisamrarn U, Wheeler CM, Skinner SR, Lehtinen M, Naud P, Chow SN, Del Rosario-Raymundo MR, Teixeira JC, Palmroth J, de Carvalho NS, Germar MJ, Peters K, Garland SM, Szarewski A, Poppe WA, Romanowski B, Schwarz TF, Tjalma WA, Bosch FX, Bozonnat MC, Struyf F, Dubin G, Rosillon D, Baril L; HPV PATRICIA Study Group. Risk of first cervical HPV infection and pre-cancerous lesions after onset of sexual activity: analysis of women in the control arm of the randomized, controlled PATRICIA trial. BMC Infect Dis. 2014 Oct 30;14:551. doi: 10.1186/s12879-014-0551-y.

Reference Type: DERIVED

PMID: 25927224 (View on PubMed)

Apter D, Wheeler CM, Paavonen J, Castellsague X, Garland SM, Skinner SR, Naud P, Salmeron J, Chow SN, Kitchener HC, Teixeira JC, Jaisamrarn U, Limson G, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, Mindel A, de Sutter P, Hardt K, Zahaf T, Descamps D, Struyf F, Lehtinen M, Dubin G; HPV PATRICIA Study Group. Efficacy of human papillomavirus 16 and 18 (HPV-16/18) AS04-adjuvanted vaccine against cervical infection and precancer in young women: final event-driven analysis of the randomized, double-blind PATRICIA trial. Clin Vaccine Immunol. 2015 Apr;22(4):361-73. doi: 10.1128/CVI.00591-14. Epub 2015 Feb 4.

Reference Type: DERIVED

PMID: 25651922 (View on PubMed)

Struyf F, Colau B, Wheeler CM, Naud P, Garland S, Quint W, Chow SN, Salmeron J, Lehtinen M, Del Rosario-Raymundo MR, Paavonen J, Teixeira JC, Germar MJ, Peters K, Skinner SR, Limson G, Castellsague X, Poppe WA, Ramjattan B, Klein TD, Schwarz TF, Chatterjee A, Tjalma WA, Diaz-Mitoma F, Lewis DJ, Harper DM, Molijn A, van Doorn LJ, David MP, Dubin G; HPV PATRICIA Study Group. Post hoc analysis of the PATRICIA randomized trial of the efficacy of human papillomavirus type 16 (HPV-16)/HPV-18 AS04-adjuvanted vaccine against incident and persistent infection with nonvaccine oncogenic HPV types using an alternative multiplex type-specific PCR assay for HPV DNA. Clin Vaccine Immunol. 2015 Feb;22(2):235-44. doi: 10.1128/CVI.00457-14. Epub 2014 Dec 24.

Reference Type: DERIVED

PMID: 25540273 (View on PubMed)

Castellsague 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.

Reference Type: DERIVED

PMID: 24610876 (View on PubMed)

Jaisamrarn U, Castellsague X, Garland SM, Naud P, Palmroth J, Del Rosario-Raymundo MR, Wheeler CM, Salmeron J, Chow SN, Apter D, Teixeira JC, Skinner SR, Hedrick J, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, de Carvalho NS, Germar MJ, Peters K, Paavonen J, Bozonnat MC, Descamps D, Struyf F, Dubin GO, Rosillon D, Baril L; HPV PATRICIA Study Group. Natural history of progression of HPV infection to cervical lesion or clearance: analysis of the control arm of the large, randomised PATRICIA study. PLoS One. 2013 Nov 19;8(11):e79260. doi: 10.1371/journal.pone.0079260. eCollection 2013.

Reference Type: DERIVED

PMID: 24260180 (View on PubMed)

Valve P, Lehtinen-Jacks S, Eriksson T, Lehtinen M, Lindfors P, Saha MT, Rimpela A, Angle S. LINDA - a solution-focused low-intensity intervention aimed at improving health behaviors of young females: a cluster-randomized controlled trial. BMC Public Health. 2013 Nov 4;13:1044. doi: 10.1186/1471-2458-13-1044.

Reference Type: DERIVED

PMID: 24188719 (View on PubMed)

Howell-Jones R, Soldan K, Wetten S, Mesher D, Williams T, Gill ON, Hughes G. Declining genital Warts in young women in england associated with HPV 16/18 vaccination: an ecological study. J Infect Dis. 2013 Nov 1;208(9):1397-403. doi: 10.1093/infdis/jit361.

Reference Type: DERIVED

PMID: 24092908 (View on PubMed)

Szarewski A, Skinner SR, Garland SM, Romanowski B, Schwarz TF, Apter D, Chow SN, Paavonen J, Del Rosario-Raymundo MR, Teixeira JC, De Carvalho NS, Castro-Sanchez M, Castellsague X, Poppe WA, De Sutter P, Huh W, Chatterjee A, Tjalma WA, Ackerman RT, Martens M, Papp KA, Bajo-Arenas J, Harper DM, Torne A, David MP, Struyf F, Lehtinen M, Dubin G. Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against low-risk HPV types (PATRICIA randomized trial): an unexpected observation. J Infect Dis. 2013 Nov 1;208(9):1391-6. doi: 10.1093/infdis/jit360.

Reference Type: DERIVED

PMID: 24092907 (View on PubMed)

Roset Bahmanyar E, Paavonen J, Naud P, Salmeron J, Chow SN, Apter D, Kitchener H, Castellsague X, Teixeira JC, Skinner SR, Jaisamrarn U, Limson GA, Garland SM, Szarewski A, Romanowski B, Aoki F, Schwarz TF, Poppe WA, De Carvalho NS, Harper DM, Bosch FX, Raillard A, Descamps D, Struyf F, Lehtinen M, Dubin G; HPV PATRICIA Study Group. Prevalence and risk factors for cervical HPV infection and abnormalities in young adult women at enrolment in the multinational PATRICIA trial. Gynecol Oncol. 2012 Dec;127(3):440-50. doi: 10.1016/j.ygyno.2012.08.033. Epub 2012 Aug 30.

Reference Type: DERIVED

PMID: 22940493 (View on PubMed)

Lehtinen M, Paavonen J, Wheeler CM, Jaisamrarn U, Garland SM, Castellsague X, Skinner SR, Apter D, Naud P, Salmeron J, Chow SN, Kitchener H, Teixeira JC, Hedrick J, Limson G, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, De Carvalho NS, Germar MJ, Peters K, Mindel A, De Sutter P, Bosch FX, David MP, Descamps D, Struyf F, Dubin G; HPV PATRICIA Study Group. Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial. Lancet Oncol. 2012 Jan;13(1):89-99. doi: 10.1016/S1470-2045(11)70286-8. Epub 2011 Nov 8.

Reference Type: DERIVED

PMID: 22075171 (View on PubMed)

Wheeler CM, Castellsague X, Garland SM, Szarewski A, Paavonen J, Naud P, Salmeron J, Chow SN, Apter D, Kitchener H, Teixeira JC, Skinner SR, Jaisamrarn U, Limson G, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, Harper DM, Huh W, Hardt K, Zahaf T, Descamps D, Struyf F, Dubin G, Lehtinen M; HPV PATRICIA Study Group. Cross-protective efficacy of HPV-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by non-vaccine oncogenic HPV types: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial. Lancet Oncol. 2012 Jan;13(1):100-10. doi: 10.1016/S1470-2045(11)70287-X. Epub 2011 Nov 8.

Reference Type: DERIVED

PMID: 22075170 (View on PubMed)

Szarewski A, Poppe WA, Skinner SR, Wheeler CM, Paavonen J, Naud P, Salmeron J, Chow SN, Apter D, Kitchener H, Castellsague X, Teixeira JC, Hedrick J, Jaisamrarn U, Limson G, Garland S, Romanowski B, Aoki FY, Schwarz TF, Bosch FX, Harper DM, Hardt K, Zahaf T, Descamps D, Struyf F, Lehtinen M, Dubin G; HPV PATRICIA Study Group. Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in women aged 15-25 years with and without serological evidence of previous exposure to HPV-16/18. Int J Cancer. 2012 Jul 1;131(1):106-16. doi: 10.1002/ijc.26362. Epub 2011 Oct 23.

Reference Type: DERIVED

PMID: 21858807 (View on PubMed)

Wacholder S, Chen BE, Wilcox A, Macones G, Gonzalez P, Befano B, Hildesheim A, Rodriguez AC, Solomon D, Herrero R, Schiffman M; CVT group. Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18: pooled analysis of two randomised controlled trials. BMJ. 2010 Mar 2;340:c712. doi: 10.1136/bmj.c712.

Reference Type: DERIVED

PMID: 20197322 (View on PubMed)

Paavonen J, Naud P, Salmeron 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. 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. doi: 10.1016/S0140-6736(09)61248-4. Epub 2009 Jul 6.

Reference Type: DERIVED

PMID: 19586656 (View on PubMed)

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):2161-2170. doi: 10.1016/S0140-6736(07)60946-5.

Reference Type: DERIVED

PMID: 17602732 (View on PubMed)

Study Documents

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

580299/008

Identifier Type: -

Identifier Source: org_study_id