GSK-759346/007

Study Sponsor: GSK

Study Title

Demonstrate non-inferiority of GSK Biologicals’ Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ with respect to anti-HBs immune response, when given to healthy infants at 6,10 & 14 weeks age, after a birth dose of hepatitis B vaccine

Medicine or Vaccine (generic name)

Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine

Sponsor Identification Number

759346/007

Trial Registry Identification Number(#'s)

NCT00317122

Medical Condition

Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=759346/007

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

http://clinicaltrials.gov/show/NCT00317122

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 follow-on study 104756 was conducted. An annotated case report form is not available for this study. A blank case report form will be provided.

Date Added to this Site

June 2015