At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Sourcing Study to Collect Human Biological (Serum) Samples From Healthy Adults
In Brief
A Phase 4 clinical trial evaluating rMenB+OMV NZ vaccine and Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY) for Meningitis, Meningococcal. Completed, enrolled 1,021 participants across 6 sites in 2 countries.
Detailed Summary
The purpose of this study was to collect large volumes of matched pairs of pre- and post-vaccination sera from healthy subjects who administered GlaxoSmithKline (GSK) Biologicals' vaccine against meningitis- MenACWY vaccine (Menveo) or rMenB+OMV NZ vaccine (Bexsero), which serves for the development, qualification, validation, and maintenance of immunological assays which supports the preclinical research activities and clinical development of GSK Biologicals' vaccines. The safety of the subjects given one of the two vaccines (Bexsero or Menveo), as per the recommended dosage and schedule were assessed during their participation in the study.
Study Details
Timeline
Interventions
Two doses of rMenB+OMV NZ vaccine were administered intramuscularly at Day 1 and Day 61.
One dose of MenACWY vaccine were administered intramuscularly at Day 1.