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

NCT ID: NCT00196924

Last Updated: 2017-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2067 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2006-03-31

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 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.

Conditions

Infections, Papillomavirus

Study Design

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

Interventions

HPV-16/18 L1/AS04

Intervention Type: BIOLOGICAL

Eligibility 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).

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 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

North Adelaide, South Australia, Australia

GSK Investigational Site

Perth, Western Australia, Australia

GSK Investigational Site

Bogotá, , Colombia

GSK Investigational Site

Bogotá, , Colombia

GSK Investigational Site

Hradec Králové, , Czechia

GSK Investigational Site

Pardubice, , Czechia

GSK Investigational Site

Aubevoye, , France

GSK Investigational Site

Broglie, , France

GSK Investigational Site

Évreux, , France

GSK Investigational Site

Luynes, , France

GSK Investigational Site

Nantes, , France

GSK Investigational Site

Nogent-le-Roi, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Pont-de-l'Arche, , France

GSK Investigational Site

Saint-Sébastien-de-Morsent, , France

GSK Investigational Site

Tours, , France

GSK Investigational Site

Verneuil-sur-Avre, , France

GSK Investigational Site

Deggingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Ettenheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Kehl, Baden-Wurttemberg, Germany

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Tauberbischofsheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Weilheim, Bavaria, Germany

GSK Investigational Site

Würzburg, Bavaria, Germany

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

GSK Investigational Site

Wolfenbüttel, Lower Saxony, Germany

GSK Investigational Site

Bützow, Mecklenburg-Vorpommern, Germany

GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, Germany

GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, Germany

GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

GSK Investigational Site

Krefeld, North Rhine-Westphalia, Germany

GSK Investigational Site

Willich, North Rhine-Westphalia, Germany

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

GSK Investigational Site

Bredstedt, Schleswig-Holstein, Germany

GSK Investigational Site

Brunsbüttel, Schleswig-Holstein, Germany

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

GSK Investigational Site

Harrislee, Schleswig-Holstein, Germany

GSK Investigational Site

Husum, Schleswig-Holstein, Germany

GSK Investigational Site

Niebüll, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Weimar, Thuringia, Germany

GSK Investigational Site

Comayagüela, , Honduras

GSK Investigational Site

Bergen, , Norway

GSK Investigational Site

Oslo, , Norway

GSK Investigational Site

Ciudad de Panama - La Chorrera, , Panama

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Alcora/Castellón, , Spain

GSK Investigational Site

Alquerías Del Niño Perdido (Castellón), , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Castellon, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Eskilstuna, , Sweden

GSK Investigational Site

Linköping, , Sweden

GSK Investigational Site

Örebro, , Sweden

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Tao Yuan County, , Taiwan

Countries

Australia; Colombia; Czechia; France; Germany; Honduras; Norway; Panama; South Korea; Spain; Sweden; Taiwan

References

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.

Reference Type: DERIVED

PMID: 24731816 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22265115 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20413076 (View on PubMed)

Study Documents

Document Type: Statistical Analysis Plan

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

View Document

Document Type: Dataset Specification

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: Individual Participant Data Set

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.

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: 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

580299/013

Identifier Type: -

Identifier Source: org_study_id