Last updated on February 2020

Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4)


Brief description of study

Primary Objective:

To demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of MenACYW conjugate vaccine in subjects who were first vaccinated with 1 dose of MenACYW conjugate vaccine or Menveo vaccine 3-6 years before the booster dose (Groups 1 and 2)

Secondary Objectives:

To describe:

  • the vaccine seroresponse, seroprotection (serum bactericidal assay using human complement [hSBA] titer 1:8), and antibody responses (geometric mean titers [GMTs]) of meningococcal serogroups A, C, Y, and W measured using hSBA in serum specimens collected 6 days (1 day) after vaccination in a subset of 50 subjects per group (Groups 1 and 2)
  • the vaccine seroresponse, seroprotection (hSBA titer 1:8), and antibody responses (GMTs) to serogroups A, C, Y, and W measured using hSBA on D0 (pre-vaccination) and D30 (+14 days) after vaccination with MenACYW conjugate vaccine alone (Groups 1 and 2)
  • the antibody persistence (GMTs and vaccine seroprotection; hSBA titer 1:8) of meningococcal serogroups A, C, Y, and W before a booster dose in subjects who received either MenACYW conjugate vaccine or Menveo vaccine 3-6 years earlier
  • the antibody persistence (GMTs and vaccine seroprotection; hSBA titer 1:8) of meningococcal serogroups A, C, Y, and W in subjects who received either a single dose MenACYW conjugate vaccine (subjects randomized to MET59 Groups 1, 3, and 4) or Menveo vaccine (subjects assigned to MET59 Group 2), as part of study MET50, or MET43 (subjects randomized to MET59 Groups 1, 3 and 4)
  • the vaccine seroresponse, seroprotection (hSBA titer 1:8), and antibody responses (GMTs) to the antigens present in MenACYW conjugate vaccine, when MenACYW conjugate vaccine is given concomitantly with MenB vaccine (Groups 3 and 4), compared to those when it is given alone (Group 1)

Detailed Study Description

Study duration per participant will be approximately 6 months including: 1 day of screening and vaccination, 1 or 2 additional visits at Day 6 and Day 30, 2 phone calls and a safety follow-up/end of study visit, at Day 8 and Day 180 after vaccine administration, respectively.

Safety assessment includes solicited reactions within 7 days after vaccination, unsolicited adverse events (AEs) up to 30 days after vaccination, serious adverse events (SAEs) throughout the study.

Clinical Study Identifier: NCT04084769

Find a site near you

Start Over

Investigational Site Number 8400010

Downey, CA United States
1.54miles
  Connect »