GSK-101518 (DTPa-HBV-IPV-103)

Study Sponsor: GSK

Study Title

A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix-hexa) given as a booster at 18-24 months of age to children who have received a three-dose primary immunisation course with the same vaccine in a previous study

Medicine or Vaccine (generic name)

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

Sponsor Identification Number

101518 (DTPa-HBV-IPV-103)

Trial Registry Identification Number(#'s)

Medical Condition

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

Phase

Phase 4

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=101518

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

Link to study details on EudraCT (if available)

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

A link to ClinicalTrials.gov and an NCTID number are not available for this study because the study is not in scope of regulatory requirements to register studies.

Date Added to this Site

September 2013