GSK-111157

Study Sponsor: GSK

Study Title

Immunogenicity and safety study of GlaxoSmithKline Biologicals’ Infanrix hexa™ vaccine in healthy infants in India

Medicine or Vaccine (generic name)

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

Sponsor Identification Number

111157

Trial Registry Identification Number(#'s)

NCT01353703 2013-003427-10

Medical Condition

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

Phase

Phase 3

Link to study details on the GSK Clinical Study Register

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

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

Date Added to this Site

February 2017