GSK-103514

Study Sponsor: GSK

Study Title

Phase 3, open, age-stratified study to assess immunogenicity and safety of GSK Biologicals' HPV-16/18 vaccine administered intramuscularly according to 3-dose schedule (0,1,6 months) in healthy female subjects aged 15 - 55 years and long term follow-up

Medicine or Vaccine (generic name)

Human Papillomavirus Types 16 and 18 Vaccine

Sponsor Identification Number

103514

Trial Registry Identification Number(#'s)

NCT00196937 2004-002083-18

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=103514

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

http://clinicaltrials.gov/show/NCT00196937

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2004-002083-18

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

Extension studies 105879, 105880, 105881 and 105882 were conducted. The results are summarised with studies 105879, 105880, 105881 and 105882 on the GSK Study Register.

Date Added to this Site

March 2014