GSK-104727

Study Sponsor: GSK

Study Title

Assess immunogenicity, safety & reactogenicity of a 4th dose of GSK Biologicals’ Tritanrix™-HepB/Hib-MenAC at 15-24 m & of a dose of Mencevax™ ACWY at 24-30 m in subjects primed with 3 doses of Tritanrix™-HepB/Hib-MenAC

Medicine or Vaccine (generic name)

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

Sponsor Identification Number

104727

Trial Registry Identification Number(#'s)

NCT00136604

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=104727 (Booster - 15-24 mths)

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

http://clinicaltrials.gov/show/NCT00136604

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

This is a follow-up study to 100480. A follow-on study 104730 was conducted. An annotated case report form is not available for this study. A blank case report form will be provided. The results of this study 104727 are summarised with studies 104730 and 100480 on the GSK Study Register.

Date Added to this Site

October 2014