GSK-103533

Study Sponsor: GSK

Study Title

Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years

Medicine or Vaccine (generic name)

Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine

Sponsor Identification Number

103533

Trial Registry Identification Number(#'s)

NCT00196976 2004-003768-32

Medical Condition

Infections, Meningococcal

Phase

Phase 2

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=103533

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

http://clinicaltrials.gov/show/NCT00196976

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2004-003768-32

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

The results of study 103533 are summarised with study 103534 on the GSK Study Register. 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 2014