drugset / Trial / NCT03493919

A Sourcing Study to Collect Human Blood Samples From Healthy Adults

NCT03493919 ↗

Phase 4 Completed 1021 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelOther

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.

Timeline

Start
2018-03-08
Primary completion
2022-05-27
Completion
2022-05-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY) Vaccine — Intramuscular
Subject rMenB+OMV NZ vaccine Vaccine — Intramuscular