Human Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio HPV-16/18. - Full Text View

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 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.

Condition	Intervention	Phase
Human Papillomavirus (HPV) Infection Cervical Neoplasia	Biological: HPV-16/18 L1/AS04	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Evaluate the Safety & Immunogenicity of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to a 0,1,6 Mth Schedule in Healthy Female Subjects (10 - 14 Years)

Resource links provided by NLM:

MedlinePlus related topics: Benign Tumors Cancer

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7. [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety of HPV vaccine in entire study period. Vaccine immunogenicity. [ Designated as safety issue: No ]

Enrollment:	2067
Study Start Date:	June 2004
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	10 Years to 14 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196924

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Locations

Australia, South Australia
GSK Investigational Site
North Adelaide, South Australia, Australia, 5006
Australia, Western Australia
GSK Investigational Site
Perth, Western Australia, Australia
Colombia
GSK Investigational Site
Bogota, Colombia
GSK Investigational Site
Bogota, Colombia, 805
Czech Republic
GSK Investigational Site
Hradec kralove, Czech Republic, 500 02
GSK Investigational Site
Pardubice, Czech Republic, 532 03
France
GSK Investigational Site
Aubevoye, France, 27940
GSK Investigational Site
Broglie, France, 27270
GSK Investigational Site
Evreux, France, 27000
GSK Investigational Site
Nantes, France, 44300
GSK Investigational Site
Nogent le Roi, France, 28210
GSK Investigational Site
Saint Sebastien de Morsent, France, 27180
GSK Investigational Site
Tours, France, 37000
GSK Investigational Site
Verneuil sur Avre, France, 27130
Germany
GSK Investigational Site
Deggingen, Baden-Wuerttemberg, Germany, 73326
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
GSK Investigational Site
Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
GSK Investigational Site
Weilheim, Bayern, Germany, 82362
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Buetzow, Mecklenburg-Vorpommern, Germany, 18246
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18109
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18147
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44866
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
GSK Investigational Site
Bredstedt, Schleswig-Holstein, Germany, 25821
GSK Investigational Site
Brunsbuettel, Schleswig-Holstein, Germany, 25541
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24939
GSK Investigational Site
Harrislee, Schleswig-Holstein, Germany, 24955
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813
GSK Investigational Site
Niebuell, Schleswig-Holstein, Germany, 25899
GSK Investigational Site
Weimar, Thueringen, Germany, 99425
GSK Investigational Site
Berlin, Germany, 10315
GSK Investigational Site
Berlin, Germany, 10967
GSK Investigational Site
Hamburg, Germany, 22307
Honduras
GSK Investigational Site
Comayaguela, Honduras
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 133--792
Norway
GSK Investigational Site
Bergen, Norway, 5053
Panama
GSK Investigational Site
Ciudad de Panama - La Chorrera, Panama
Spain
GSK Investigational Site
Alcora/Castellón, Spain, 12110
GSK Investigational Site
Alquerías del Niño Perdido (Castellón), Spain, 12539
GSK Investigational Site
Barcelona, Spain, 08037
GSK Investigational Site
Castellon, Spain
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Valencia, Spain, 46017
Sweden
GSK Investigational Site
Eskilstuna, Sweden, SE-631 88
GSK Investigational Site
Linköping, Sweden, SE-581 85
Taiwan
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Tao Yuan County, Taiwan, 333

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Publications:

Schwarz T et al. Long-term safety and immunogenicity of a human papillomavirus (HPV)-16/18 AS04 adjuvanted cervical cancer vaccine in girls aged 10-14 years: 36-month follow-up. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.

Descamps D et al. (2009) Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: A pooled analysis of 11 clinical trials. Hum Vaccin. 5(5):51-59.

Medina DMR et al. (2010) Safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine: a randomised, controlled trial in adolescent girls. J Adolesc Health. 46(5):414-421.

Rombo L et al. Tolerability of HPV-16/18 AS04-adjuvanted cervical cancer vaccine. Abstract presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) International Multidisciplinary Conference. Nice, France, 12-15 November 2008.

Schwarz TF et al. Long-term safety and immunogenicity of an AS04 adjuvanted cervical cancer vaccine in girls aged 10-14 years. Abstract presented at the 26th Annual Meeting of the ESPID. Graz, Austria, 13-17 May 2008.

Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8.

Brussels, Belgium, 9-13 June 2009. Schwarz TF et al. Safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine in adolescent girls: long-term follow-up of a randomised trial. Abstract presented at the 28th annual ESPID meeting, Nice, France, 4-8 May 2010.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schwarz 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.

Medina DM, Valencia A, de Velasquez A, Huang LM, Prymula R, García-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.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00196924 History of Changes
Other Study ID Numbers:	580299/013
Study First Received:	September 13, 2005
Last Updated:	November 21, 2012
Health Authority:	Panama: Ministry of Health

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013