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Pilot Study of the Immunogenicity, Reactogenicity and Tolerability of Two Schedules of a 4CmenB Vaccine in Adolescents and Young Adults

NCT02583412 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-01-31

No results posted yet for this study

Summary

The overall aim of this study is to determine if an accelerated "Bexsero® (Multicomponent meningococcal B vaccine)" schedule compared to a standard schedule is immunogenic, safe, and tolerable, in order to increase capacity for rapid outbreak control. In this pilot study no formal hypothesis is tested.

Conditions

  • Meningococcal Serogroup B

Interventions

BIOLOGICAL

Bexsero®

Multicomponent meningococcal B vaccine

BIOLOGICAL

Havrix®

Hepatitis A vaccine

Sponsors & Collaborators

  • University of British Columbia

    collaborator OTHER

  • University of Calgary

    collaborator OTHER

  • Université de Montréal

    collaborator OTHER

  • Dalhousie University

    collaborator OTHER

  • Canadian Immunization Research Network

    lead NETWORK

Principal Investigators

  • Joanne M Langley, MD, MSc, FRCPC · IWK Health Centre, Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-09-30
Completion
2017-06-30

Countries

  • Canada

Study Locations

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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 NCT02583412 on ClinicalTrials.gov