Infections, Papillomavirus Clinical Trial
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.]
HPV infection has been established as a necessary cause of cervical cancer. GSK Biologicals
has developed an HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) 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 3 additional years.
This Protocol Posting has been updated following Protocol Amendment 25, November 2010 ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01290393 -
Post-marketing Study to Assess the Safety of CERVARIX When Used in the United States and in Canada
|
||
| Completed |
NCT00369824 -
Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects
|
Phase 3 | |
| Completed |
NCT00345878 -
Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years
|
Phase 3 | |
| Completed |
NCT00947115 -
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
|
Phase 3 | |
| Completed |
NCT01187927 -
Drug Use Investigation for Cervarix®
|
N/A | |
| Completed |
NCT00169494 -
Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18
|
Phase 3 | |
| Completed |
NCT01190176 -
Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects
|
Phase 3 | |
| Completed |
NCT00359619 -
Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine
|
Phase 2 | |
| Completed |
NCT00196937 -
Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18
|
Phase 3 | |
| Completed |
NCT00534638 -
Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents
|
Phase 4 | |
| Completed |
NCT00250276 -
Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.
|
Phase 3 | |
| Completed |
NCT01031069 -
Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females
|
Phase 4 | |
| Completed |
NCT00996125 -
Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects
|
Phase 3 | |
| Completed |
NCT00779766 -
Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects
|
Phase 3 | |
| Completed |
NCT01953822 -
Study Assessing Risk of Autoimmune Diseases in Females (9 - 25 Years) Exposed to Cervarix® in United Kingdom
|
N/A | |
| Completed |
NCT01153906 -
Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination
|
N/A | |
| Completed |
NCT01207999 -
Type Distribution of Human Papillomavirus in Adult African Women Diagnosed With Invasive Cervical Cancer
|
N/A | |
| Completed |
NCT00693615 -
Safety and Immunogenicity Study of MEDI-517 (GSK 580299) With or Without Adjuvant in Healthy Adult Females
|
Phase 2 | |
| Completed |
NCT00693966 -
Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517 (GSK 580299) in Healthy Adult Females
|
Phase 2 | |
| Completed |
NCT00541970 -
Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs
|
Phase 1 |