Status:
COMPLETED
Study in Adolescents/Adults to Evaluate the Persistence up to 3.5 Yrs of GSK Biologicals Meningococcal Vaccine 134612
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Meningococcal
Eligibility:
All Genders
15-19 years
Phase:
PHASE2
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- • Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since the last visit of the primary vaccination study.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00390143
Start Date
February 1 2007
End Date
May 1 2009
Last Update
October 25 2016
Active Locations (1)
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1
GSK Investigational Site
Aarhus N, Denmark, 8200