GSK-106794

Study Sponsor: GSK

Study Title

Persistence of hepatitis B antibodies, immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ hepatitis B vaccine, Engerix™-B Kinder (SKF103860) challenge dose, in adolescents vaccinated with four doses of Infanrix™ hexa (SB217744) during infancy

Medicine or Vaccine (generic name)

INFANRIX PENTA/INFANRIX HEXA / PEDIARIX

Sponsor Identification Number

106794

Trial Registry Identification Number(#'s)

NCT02798952 2015-003391-74

Medical Condition

Hepatitis B

Phase

Phase 4

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=106794

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

http://clinicaltrials.gov/show/NCT02798952

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-003391-74

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

An annotated case report form is not available for this study. A blank case report form will be provided.

Date Added to this Site

May 2018