Study in Adolescents/Adults to Evaluate the Persistence up to 3.5 Yrs of GSK Biologicals Meningococcal Vaccine 134612
Study in Adolescents/Adults to Evaluate the Persistence up to 3.5 Yrs of GSK Biologicals Meningococcal Vaccine 134612
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.
Subjects were previously vaccinated at 15 to 19 years of age with GSK Biologicals'
 meningococcal vaccine 134612 or with Mencevax™ ACWY. This extension phase starts 18 months
 after vaccination and part of the subjects will be enrolled in this extension phase. No
 additional vaccines will be administered during this study and no new subjects will be
 enrolled. The subjects will have three blood samples taken: at 18, 30 and 42 months after
 vaccination.
Inclusion Criteria:

 -  Subjects who the investigator believes that they and/or their parents/guardians can
 and will comply with the requirements of the protocol.

 -  A male or female, who was primed with meningococcal vaccine 134612 or Mencevax™ ACWY
 in the primary vaccination study 18 months before the first persistence assessment and
 who completed that study.

 -  Written informed consent obtained from the subject/ from the parent or guardians of
 the subject.

 -  Written informed assent obtained from the subject, as applicable, at the time of study
 entry.

 Exclusion Criteria:

 • Administration of a meningococcal polysaccharide or a meningococcal polysaccharide
 conjugate vaccine since the last visit of the primary vaccination study.