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| Sponsor: | 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 as the study will be extended by 2 additional years. Amendment Act, Sep 2007.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer Papillomavirus Infection |
Biological: Gardasil ® (Merck & Co. Inc) Biological: Placebo Biological: GSK Biologicals HPV 16/18 vaccine 580299 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), 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.] |
| Enrollment: | 1106 |
| Study Start Date: | January 2007 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
HPV Group: Experimental
Subjects in each group will be stratified by age (18-26 Cohort, 27-35 Cohort and 36-45 Cohort)
|
Biological: Placebo
One dose administered intramuscularly at month 2 or month 1 to maintain blinding
Biological: GSK Biologicals HPV 16/18 vaccine 580299
Three doses administered intramuscularly at months 0, 1 and 6
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Gardasil Group: Active Comparator
Subjects in each group will be stratified by age (18-26 Cohort, 27-35 Cohort and 36-45 Cohort)
|
Biological: Gardasil ® (Merck & Co. Inc)
Three doses administered intramuscularly at months 0, 2 and 6
Biological: Placebo
One dose administered intramuscularly at month 2 or month 1 to maintain blinding
|
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 40 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 108933 |
| Study First Received: | January 16, 2007 |
| Last Updated: | May 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00423046 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Cervical cancer Viral infections Comparative study Adults Humans |
Human papillomavirus vaccine Human papillomavirus (HPV) Vaccines Immunogenicity Safety |
|
Virus Diseases Communicable Diseases Tumor Virus Infections |
DNA Virus Infections Papillomavirus Infections Infection |