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Study to Assess the Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's (GSK) Meningococcal MenACWY-CRM Vaccine (Menveo), Administered to Subjects 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination

Infections, Meningococcal Clinical Trial

Official title:
A Phase 3b, Controlled, Open-Label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's Meningococcal ACWY Conjugate Vaccine (Menveo), Administered to Healthy Individuals 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination

Clinical Trial Summary

The purpose/aim of this study is to assess the safety and antibody response to vaccination with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess the safety and antibody response to a single dose of Menveo given to vaccine-naïve subjects

Clinical Trial Description

This is a phase 3b, controlled, open-label, multi-center study to evaluate safety and immunogenicity of Menveo after a single vaccination in healthy individuals who were vaccinated with Menveo or Menactra 4 to 6 years before and in vaccine-naive individuals. Vaccine-naive subjects: subjects who have not received any meningococcal vaccine prior to participation to this clinical trial.

Subjects will be randomised into one of the two different blood draw schedules according to a 1:1 ratio.

- Blood draws at Day 1, Day 4 and Day 29

- Blood draws at Day 1, Day 6 and Day 29 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02986854
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date December 8, 2016
Completion date December 7, 2017
View Details
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