Clinical Trial: 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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Health

Brief 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 Summary:

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

Sponsor: GlaxoSmithKline

Current Primary Outcome: Percentages of subjects with hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, from Menveo-Menveo and Menactra-Menveo groups. [ Time Frame: At Day 29 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentages of subjects with hSBA titer ≥8 and ≥16 against N. meningitidis serogroups A, C, W and Y and between-group differences. [ Time Frame: At Day 1, Day 4, Day 6 and Day 29 ]
  • Percentages of subjects with hSBA seroresponse against N. meningitidis serogroups A, C, W and Y and between-group differences. [ Time Frame: At Day 4, Day 6 and Day 29 ]
  • hSBA GMTs against N. meningitidis serogroup A, C, W and Y. [ Time Frame: At Day 1, Day 4, Day 6 and Day 29 ]
  • Ratios of hSBA GMTs (between study groups). [ Time Frame: At Day 1, Day 4, Day 6, and Day 29 ]
  • hSBA Geometric Mean Ratios (GMRs) (within study groups). [ Time Frame: At Day 4, Day 6, Day 29 compared to Day 1 ]
  • Any unsolicited Adverse Events (AEs) reported. [ Time Frame: Within 30 minutes after vaccination ]
  • Solicited local and systemic AEs reported. [ Time Frame: From Day 1 (6 hours) through Day 7 after vaccination ]
  • Other indicators of reactogenicity (eg, use of analgesics/antipyretics, body temperature). [ Time Frame: From Day 1 (6 hours) through Day 7 after vaccination ]
  • All unsolicited AEs reported. [ Time Frame: From Day 1 through Day 29 after vaccination ]
  • Medically-attended AEs, AEs leading to withdrawal and SAEs reported. [ Time Frame: From Day 1 through Day 181 (entire study period) ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: December 6, 2016
Date Started: December 8, 2016
Date Completion: February 22, 2018
Last Updated: May 18, 2017
Last Verified: May 2017