GSK-108052

Study Sponsor: GSK

Study Title

A long-term, follow-up of the immunogenicity and safety of GlaxoSmithKline Biologicals’ novel HPV vaccine in healthy female subjects vaccinated in the primary study

Medicine or Vaccine (generic name)

Human Papillomavirus Types 16 and 18 Vaccine

Sponsor Identification Number

108052

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 107918, 107919 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