|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
GlaxoSmithKline |
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00423046 |
Purpose
HPV infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV-16/18 L1 VLP AS04 vaccine which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in > 70%, approximately, of all cervical cancers. Recently, Merck's HPV vaccine Gardasil® [quadrivalent human papillomavirus (HPV-6,11,16,18 L1 VLP) recombinant vaccine] has been approved by the FDA for prevention of genital tract cancers and pre-cancers and genital warts in females. Although the GSK HPV vaccine and Gardasil® have different compositions and are expected to have different efficacy profiles, each vaccine targets prevention of HPV-16 and 18 genital tract cancers and pre-cancers. Therefore, a comparison of the immunogenicity of the two vaccines is warranted. This Phase 3b study is designed to compare the immunogenicity of the GSK vaccine (HPV-16/18) to Gardasil® in healthy adult females 18-45 years of age.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
| Condition | Intervention | Phase |
|
Cervical Cancer Papillomavirus Infections |
Biological: HPV-16/18 L1/AS04 (580299) |
Phase III |
| MedlinePlus related topics: | Cancer Cervical Cancer |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase IIIb, Observer-Blind Study to Compare Immunogenicity of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Versus Gardasil® [Quadrivalent Human Papillomavirus (HPV-6,11,16,18 L1 VLP) Recombinant Vaccine Merck & Co., Inc.] |
| Estimated Enrollment: | 1042 |
| Study Start Date: | January 2007 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Eligibility
| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations![]() |
Show 23 Study Locations |
| GlaxoSmithKline |
| Study Director: | Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK Biologicals ( Isabelle Harpigny ) |
| Study ID Numbers: | 108933 |
| First Received: | January 16, 2007 |
| Last Updated: | April 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00423046 |
| Health Authority: | United States: Food and Drug Administration |
|
|
|
|
|