Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00478621 |
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go 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. GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate a novel GSK Biologicals' HPV vaccine (GSK1674330A) in terms of safety and immunogenicity compared to the control vaccine. There will be different levels of blinding in the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
---|---|---|
Human Papillomavirus (HPV) Infection Cervical Neoplasia |
Biological: Cervarix TM Biological: GSK Biologicals' HPV vaccine (GSK1674330A) |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicentre Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine (GSK1674330A) in Healthy Female Subjects Aged 18-25 Years. |
Enrollment: | 540 |
Study Start Date: | May 2007 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group F: Active Comparator |
Biological: Cervarix TM
Intramuscular administration
|
Group E: Experimental |
Biological: GSK Biologicals' HPV vaccine (GSK1674330A)
Intramuscular administration, 5 different formulations
|
Group C: Experimental |
Biological: GSK Biologicals' HPV vaccine (GSK1674330A)
Intramuscular administration, 5 different formulations
|
Group D: Experimental |
Biological: GSK Biologicals' HPV vaccine (GSK1674330A)
Intramuscular administration, 5 different formulations
|
Group A: Experimental |
Biological: GSK Biologicals' HPV vaccine (GSK1674330A)
Intramuscular administration, 5 different formulations
|
Group B: Experimental |
Biological: GSK Biologicals' HPV vaccine (GSK1674330A)
Intramuscular administration, 5 different formulations
|
Ages Eligible for Study: | 18 Years to 25 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Enrolment will be deferred until the subject is outside of specified window.
Belgium | |
GSK Investigational Site | |
Gent, Belgium, 9000 | |
GSK Investigational Site | |
Bruxelles, Belgium, 1070 | |
GSK Investigational Site | |
Wilrijk, Belgium, 2610 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 109836 |
Study First Received: | May 24, 2007 |
Last Updated: | April 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00478621 History of Changes |
Health Authority: | Belgium: Ministry of Health |
HPV |
Healthy |
Infection |