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

Launched by GLAXOSMITHKLINE · Oct 17, 2006

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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.