Study in Adolescents/Adults to Evaluate the Persistence up to 3.5 Yrs of GSK Biologicals Meningococcal Vaccine 134612

Summary

This study will investigate the long-term protection offered by GSK Biologicals' meningococcal vaccine 134612 up to 3.5 years after vaccination. Subjects were vaccinated at 15 to 19 years of age. This extension phase starts 18 months after vaccination and part of the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled. This protocol posting deals with objectives \& outcome measures of the extension phase 18, 30 and 42 months after vaccination. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00126945). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Timeline

Start

2007-02

Primary completion

2009-05

Completion

2009-05

Publications

• Background Ostergaard L, Van der Wielen M, Bianco V, Miller JM. Persistence of antibodies for 42 months following vaccination of adolescents with a meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine (MenACWY-TT). Int J Infect Dis. 2013 Mar;17(3):e173-6. doi: 10.1016/j.ijid.2012.10.001. Epub 2012 Dec 13.

Drugs

Indications