GSK-113978

Study Sponsor: GSK

Study Title

Immunogenicity and safety study of GlaxoSmithKline Biologicals’ GSK2202083A vaccine administered as a booster dose in 12-18 months old healthy children

Medicine or Vaccine (generic name)

Combined Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B, Inactivated Polio, Haemophilus influenzae Type b Vaccine

Sponsor Identification Number

113978

Trial Registry Identification Number(#'s)

NCT01171989 2010-019253-18

Medical Condition

Acellular Pertussis; Diphtheria; Haemophilus influenzae type b; Hepatitis B; Poliomyelitis; Tetanus

Phase

Phase 2

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=113978

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

http://clinicaltrials.gov/show/NCT01171989

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2010-019253-18

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

Date Added to this Site

May 2013