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

Infections, Papillomavirus Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196924
• Other study ID #: 580299/013
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: March 21, 2017
• Start date: June 2004
• Est. completion date: March 2006

Study information

• Verified date: March 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2067
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 14 Years

Eligibility

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).

Related Conditions & MeSH terms

• Infections, Papillomavirus

Intervention

Biological:
• HPV-16/18 L1/AS04

Locations

Country	Name	City	State
Australia	GSK Investigational Site	North Adelaide	South Australia
Australia	GSK Investigational Site	Perth	Western Australia
Colombia	GSK Investigational Site	Bogota
Colombia	GSK Investigational Site	Bogota
Czech Republic	GSK Investigational Site	Hradec kralove
Czech Republic	GSK Investigational Site	Pardubice
France	GSK Investigational Site	Aubevoye
France	GSK Investigational Site	Broglie
France	GSK Investigational Site	Evreux
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 Sebastien de Morsent
France	GSK Investigational Site	Tours
France	GSK Investigational Site	Verneuil sur Avre
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bredstedt	Schleswig-Holstein
Germany	GSK Investigational Site	Brunsbuettel	Schleswig-Holstein
Germany	GSK Investigational Site	Buetzow	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Deggingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Ettenheim	Baden-Wuerttemberg
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	Hamburg
Germany	GSK Investigational Site	Harrislee	Schleswig-Holstein
Germany	GSK Investigational Site	Husum	Schleswig-Holstein
Germany	GSK Investigational Site	Kehl	Baden-Wuerttemberg
Germany	GSK Investigational Site	Krefeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Niebuell	Schleswig-Holstein
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Tauberbischofsheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Trier	Rheinland-Pfalz
Germany	GSK Investigational Site	Weilheim	Bayern
Germany	GSK Investigational Site	Weimar	Thueringen
Germany	GSK Investigational Site	Willich	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wolfenbuettel	Niedersachsen
Germany	GSK Investigational Site	Wuerzburg	Bayern
Honduras	GSK Investigational Site	Comayaguela
Korea, Republic of	GSK Investigational Site	Seoul
Norway	GSK Investigational Site	Bergen
Norway	GSK Investigational Site	Oslo
Panama	GSK Investigational Site	Ciudad de Panama - La Chorrera
Spain	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
Sweden	GSK Investigational Site	Eskilstuna
Sweden	GSK Investigational Site	Linköping
Sweden	GSK Investigational Site	Örebro
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Tao Yuan County

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Australia,  Colombia,  Czech Republic,  France,  Germany,  Honduras,  Korea, Republic of,  Norway,  Panama,  Spain,  Sweden,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.
Secondary	Safety of HPV vaccine in entire study period. Vaccine immunogenicity.

External 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.