NCT02986854

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 704 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 15 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed 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

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)	One intramuscular injection of MenACWY at Day 1.

Timeline

• Start date: 2016-12-08
• Primary completion: 2017-07-17
• Completion: 2017-12-07
• First posted: 2016-12-08
• Last updated: 2019-11-25
• Results posted: 2018-08-03

Locations

37 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study