GSK-107919

Study Sponsor: GSK

Study Title

A dose-range study to assess the safety and immunogenicity of a novel HPV vaccine when administered intramuscularly according to a 3-dose schedule (0,1,6-month) in healthy adult females (18-25 years of age)

Medicine or Vaccine (generic name)

Human Papillomavirus Types 16 and 18 Vaccine

Sponsor Identification Number

107919

Trial Registry Identification Number(#'s)

NCT00359619 2004-003766-14

Medical Condition

Infections, Papillomavirus

Phase

Phase 2

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=102115

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

http://clinicaltrials.gov/show/NCT00359619

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2004-003766-14

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 107918 and 107921 were conducted. The results of this study are summarised under study 102115 on the GSK Study Register with studies 108052, 107918 and 107921. An annotated case report form is not available for this study. A blank case report form will be provided. A reporting and analysis plan is not available for this study.

Date Added to this Site

March 2014