GSK-110478

Study Sponsor: GSK

Study Title

Immunogenicity and reactogenicity study of a new formulation of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine administered as a booster dose to 18-23 months old children

Medicine or Vaccine (generic name)

Combined Diphtheria, Tetanus, Acellular Pertussis Adsorbed, Hepatitis B (Recombinant), Inactivated Polio Vaccine

Sponsor Identification Number

110478

Trial Registry Identification Number(#'s)

NCT00611559 2012-002428-34

Medical Condition

Acellular pertussis; Diphtheria; Hepatitis B; Poliomyelitis; Tetanus

Phase

Phase 4

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=110478

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

http://clinicaltrials.gov/show/NCT00611559

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-002428-34

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