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A Sourcing Study to Collect Human Blood Samples From Healthy Adults

NCT03493919 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1021

Last updated 2023-07-17

Study results available
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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.

Conditions

  • Meningitis, Meningococcal

Interventions

BIOLOGICAL

rMenB+OMV NZ vaccine

Two doses of rMenB+OMV NZ vaccine were administered intramuscularly at Day 1 and Day 61.

BIOLOGICAL

Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)

One dose of MenACWY vaccine were administered intramuscularly at Day 1.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-08
Primary Completion
2022-05-27
Completion
2022-05-27
FDA Drug
Yes

Countries

  • Australia
  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03493919 on ClinicalTrials.gov