GSK-112021

Study Sponsor: GSK

Study Title

The long term antibody persistence study of GSK Biologicals’ meningococcal vaccine GSK 134612 administered as 1 or 2 doses to healthy toddlers at 9-12 months of age and as a booster dose at 5 years post-primary vaccination

Medicine or Vaccine (generic name)

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

Sponsor Identification Number

112021

Trial Registry Identification Number(#'s)

NCT00718666 2012-002719-24

Medical Condition

Infections, Meningococcal

Phase

Phase 2

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=112021

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

http://clinicaltrials.gov/show/NCT00718666

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-002719-24

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 109375. 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 2015