Infections, Papillomavirus Clinical Trial
Official title:
A Phase II Study to Assess the Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix TM) Vaccine Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Japanese Female Subjects Aged 20 - 25 Years.
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. This study will evaluate the efficacy in prevention of persistent HPV-16 or
HPV-18 cervical infection lasting at least 6 months, the immunogenicity and safety of GSK
Biologicals HPV-16/18 vaccine (Cervarix TM ) over 24 months in Japanese adult women aged 20 -
25 years of age at study start. Approximately 1000 study subjects will either receive the HPV
vaccine or a control vaccine (Hepatitis A vaccine) administered intramuscularly according to
a 0-1-6 month schedule.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
The Protocol Posting has been updated to reflect changes as a consequence of an amendment to the protocol. Sections impacted are Official Title of the study and Intervention name. ;
| 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 |