Infections, Papillomavirus Clinical Trial
Official title:
Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of a HPV Vaccine (GSK 580299) in Healthy Female Subjects
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals with objectives & outcome measures of the extension phase from Month 60 to Month 120. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The objectives & outcome measures of the extension phase up to Month 48 are presented in a separate protocol posting (NCT00316706).
Subjects were aged 10-14 years at the time of entry into the primary study. No vaccine will
be administered in this extension study.
Results on outcome measures describing analyses on other studies are not reported in this
record. Please refer to the records mentioned in the respective outcome measure titles.
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| 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 |