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Combined Study - Phase 3b MenB Long Term Persistence in Adolescents

NCT02446743 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 531

Last updated 2018-11-08

Study results available
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Summary

The purpose/aim of this study is to assess 1) the long-term persistence (4 to 7.5 years after the last dose) of bactericidal activity following primary vaccination with rMenB+OMV NZ in adolescents \[who previously participated in parent studies V72\_41 (NCT0142384) and V72P10 (NCT00661713)\] and 2) the kinetics of immune response following booster vaccination with rMenB+OMV NZ

Conditions

  • Infections, Meningococcal

Interventions

BIOLOGICAL

rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine)

One dose of the vaccine administered intramuscularly in the deltoid area of the non-dominant arm.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-17
Primary Completion
2016-09-23
Completion
2016-09-23
FDA Drug
Yes

Countries

  • Australia
  • Canada
  • Chile

Study Locations

More Related Trials

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 NCT02446743 on ClinicalTrials.gov