GSK-811936/001 (Hib-MenC-TT-001)

Study Sponsor: GSK

Study Title

Phase 2, open, randomized, controlled study to demonstrate the non-inferiority of the meningococcal serogroup C immune response and the superiority of the Hib immune response of GSK Biologicals’ Haemophilus influenzae type b-meningococcal C-TT conjugate vaccine administered with Infanrix™ penta versus Meningitec™ administered with Infanrix™

Medicine or Vaccine (generic name)

Meningococcal Vaccine

Sponsor Identification Number

811936/001 (Hib-MenC-TT-001)

Trial Registry Identification Number(#'s)

Medical Condition

Infections, Meningococcal

Phase

Phase 2

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=811936/001

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. 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

June 2015