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Clinical Trial Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT00578227
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date December 15, 2007
Completion date April 28, 2009

See also
  Status Clinical Trial Phase
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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