GSK-102115

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

102115

Trial Registry Identification Number(#'s)

NCT00231413 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/NCT00231413

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 102115 are summarised with studies 107918, 107921, 107919 and 108052 on the GSK Study Register. 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