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

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.

Study Overview

• Status: Completed
• Conditions: Infections, Papillomavirus
• Intervention / Treatment: Biological: HPV-16/18 L1/AS04

• Study Type: Interventional
• Enrollment (Actual): 2067
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • North Adelaide, South Australia, Australia, 5006
      • GSK Investigational Site
  • Western Australia
    • Perth, Western Australia, Australia
      • GSK Investigational Site
• Colombia
  • Bogota, Colombia
    • GSK Investigational Site
  • Bogota, Colombia, 805
    • GSK Investigational Site
• Czech Republic
  • Hradec kralove, Czech Republic, 500 02
    • GSK Investigational Site
  • Pardubice, Czech Republic, 532 03
    • GSK Investigational Site
• France
  • Aubevoye, France, 27940
    • GSK Investigational Site
  • Broglie, France, 27270
    • GSK Investigational Site
  • Evreux, France, 27000
    • GSK Investigational Site
  • Luynes, France, 37230
    • GSK Investigational Site
  • Nantes, France, 44300
    • GSK Investigational Site
  • Nogent le Roi, France, 28210
    • GSK Investigational Site
  • Paris, France, 75014
    • GSK Investigational Site
  • Pont De L Arche, France
    • GSK Investigational Site
  • Saint Sebastien de Morsent, France, 27180
    • GSK Investigational Site
  • Tours, France, 37000
    • GSK Investigational Site
  • Verneuil sur Avre, France, 27130
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10315
    • GSK Investigational Site
  • Berlin, Germany, 10967
    • GSK Investigational Site
  • Hamburg, Germany, 22307
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • 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
  • Bayern
    • Weilheim, Bayern, Germany, 82362
      • GSK Investigational Site
    • Wuerzburg, Bayern, Germany, 97070
      • GSK Investigational Site
  • Mecklenburg-Vorpommern
    • Buetzow, Mecklenburg-Vorpommern, Germany, 18246
      • GSK Investigational Site
    • Rostock, Mecklenburg-Vorpommern, Germany, 18109
      • GSK Investigational Site
    • Rostock, Mecklenburg-Vorpommern, Germany, 18147
      • GSK Investigational Site
  • Niedersachsen
    • Wolfenbuettel, Niedersachsen, Germany, 38302
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44866
      • GSK Investigational Site
    • Krefeld, Nordrhein-Westfalen, Germany, 47798
      • GSK Investigational Site
    • Willich, Nordrhein-Westfalen, Germany, 47877
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Trier, Rheinland-Pfalz, Germany, 54290
      • GSK Investigational Site
  • Schleswig-Holstein
    • 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
    • Flensburg, Schleswig-Holstein, Germany, 24943
      • GSK Investigational Site
    • Flensburg, Schleswig-Holstein, Germany, 24944
      • 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
  • Thueringen
    • Weimar, Thueringen, Germany, 99425
      • GSK Investigational Site
• Honduras
  • Comayaguela, Honduras
    • GSK Investigational Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 133--792
    • GSK Investigational Site
• Norway
  • Bergen, Norway, 5053
    • GSK Investigational Site
  • Oslo, Norway, 0370
    • GSK Investigational Site
• Panama
  • Ciudad de Panama - La Chorrera, Panama
    • GSK Investigational Site
• Spain
  • 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
    • GSK Investigational Site
• Sweden
  • Eskilstuna, Sweden, SE-631 88
    • GSK Investigational Site
  • Linköping, Sweden, SE-581 85
    • GSK Investigational Site
  • Örebro, Sweden, SE-701 85
    • GSK Investigational Site
• Taiwan
  • Taipei, Taiwan, 100
    • GSK Investigational Site
  • Tao Yuan County, Taiwan, 333
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.

Secondary Outcome Measures

Outcome Measure
Safety of HPV vaccine in entire study period. Vaccine immunogenicity.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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. doi: 10.1016/j.jadohealth.2011.11.004.
• Boxus 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.
• Medina 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): March 1, 2006
• Study Completion (Actual): March 1, 2006

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Actual): March 23, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 580299/013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Statistical Analysis Plan
   Information identifier: 580299/013
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: 580299/013
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Informed Consent Form
   Information identifier: 580299/013
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Individual Participant Data Set
   Information identifier: 580299/013
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 580299/013 are summarised with studies 104896 (M18), 104902 (M24), 104904 (M36) and 104918 (M48) on the GSK Clinical Study Register.
5. Study Protocol
   Information identifier: 580299/013
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Clinical Study Report
   Information identifier: 580299/013
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Annotated Case Report Form
   Information identifier: 580299/013
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register