GSK-107921

Study Sponsor: GSK

Study Title

A double-blind, controlled, randomised, phase II study of the safety and immunogenicity of an HPV-VLP vaccine against Human Papillomavirus Types 16, 18, 31 and 45 evaluated in Healthy Adult Female Volunteers in a 0, 1, 6 months schedule

Medicine or Vaccine (generic name)

GSK568893A

Sponsor Identification Number

107921

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

This is a follow-up study to 102115, 108052 and 107919. A follow-on study 107918 was conducted. The results of this study are summarised under study 102115 on the GSK Study Register with studies 108052, 107919 and 107918. 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 2019