Infections, Papillomavirus Clinical Trial
Official title:
Follow-up Study to Evaluate the Long-term Efficacy of a HPV Vaccine (580299) in Healthy Young Adult Women in Brazil
Infection with human papillomavirus (HPV) has been clearly established as the central cause
of cervical cancer. This Phase IIb study is designed to evaluate the the long-term efficacy,
safety and immunogenicity of the 580299 HPV vaccine (CervarixTM) in a Brazilian cohort of
women vaccinated in the phase IIb, blinded, primary study 580299/001 (NCT00689741) and
having participated in follow-up study 580299/007 (NCT00120848). Only subjects who
participated in the primary & follow-up study will be enrolled in this long-term follow-up
study. Subjects were aged 15-25 years at the time of entry into the primary study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
In this extension study, women who were vaccinated in the primary study, and participated in the follow-up study, will be followed with visits every 6 months. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| 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 |