A Phase 2 interventional study of Meningococcal vaccine 134612 and Mencevax™ ACWY in Infections, Meningococcal, sponsored by GlaxoSmithKline. Completed at 1 site in Denmark. Open to participants aged 15 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-25.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
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.
219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.
This study's enrollment of 46 is below the median of 450 across 190 interventional studies indexed under Meningococcal Infections.
Browse Meningococcal Infections studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects previously primed with meningococcal vaccine 134612.
Biological: Meningococcal vaccine 134612
Subjects previously primed with Mencevax™ ACWY.
Biological: Mencevax™ ACWY
One intramuscular dose during the primary study
One subcutaneous dose during the primary study
Meningococcal rSBA titres.
Time frame: At the start of this persistence study and 12 and 24 months later.
Anti-meningococcal polysaccharide concentrations
Time frame: At the start of this persistence study and 12 and 24 months later.
Occurrence of serious adverse events related to vaccination, adverse events related to lack of vaccine efficacy or study participation.
Time frame: From the last study contact of the primary vaccination study to the end of this persistence study.
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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