GSK-104820

Study Sponsor: GSK

Study Title

A study to evaluate safety, immunogenicity and efficacy of GSK Biologicals HPV-16/18 L1/AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy adult female subjects aged 26 years and above

Medicine or Vaccine (generic name)

Human Papillomavirus Types 16 and 18 Vaccine

Sponsor Identification Number

104820

Trial Registry Identification Number(#'s)

NCT00294047 2005-002546-20

Medical Condition

Infections, Papillomavirus

Phase

Phase 3

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=104820

Link to study details on ClinicalTrials.gov (if available)

http://clinicaltrials.gov/show/NCT00294047

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2005-002546-20

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

Follow-on studies 109801, 113621, 113618 and 113617 were conducted. An annotated case report form is not available for this study. A blank case report form will be provided.

Date Added to this Site

March 2014