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Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK134612

Infections, Meningococcal Clinical Trial

Official title:
Persistence of Antibodies After GSK Biologicals' Meningococcal Vaccine GSK134612 in Toddlers

Clinical Trial Summary

Subjects were previously vaccinated at 12 to 23 months of age. This extension study starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled.

Clinical Trial Description

This study will assess the long-term protection offered by the new meningococcal vaccine GSK 134612 compared to Meningitec™ up to 4 years after vaccination of toddlers. Subjects were previously vaccinated at 12 to 23 months of age with GSK Biologicals' meningococcal vaccine GSK 134612 or Meningitec™. All subjects received at least one dose of Priorix-Tetra™. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension study. No new subjects will be enrolled. The subjects will have a blood sample taken at 24, 36 and 48 months after primary vaccination. At Year 4 subjects will be boosted with the same meningococcal vaccine as given in the primary study, i.e. either the new meningococcal vaccine GSK 134612 or Meningitec™. Blood samples will be taken 1 and 12 months after the booster vaccination. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00955682
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date August 25, 2009
Completion date September 10, 2012
View Details
See also
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