Last updated on June 2020

Study of a Quadrivalent Meningococcal Conjugate Vaccine Compared With Two Meningococcal Reference Vaccines in Europeans Toddlers


Brief description of study

Primary Objective:

To demonstrate:

  • the non-inferiority of the seroprotection rate (antibody titers 1:8) to meningococcal serogroup C following the administration of MenACYW conjugate or Nimenrix as measured by serum bactericidal assay using human complement (hSBA). If this non-inferiority is demonstrated, then
  • the non-inferiority of the antibody response (geometric mean titers [GMT]). If this non-inferiority is demonstrated, then
  • the superiority of the antibody response (GMT).If this superiority is demonstrated, then
  • the superiority of the seroprotection rate

Or to demonstrate:

  • the non-inferiority of the seroprotection rate (antibody titers 1:8) to meningococcal serogroup C following the administration of MenACYW conjugate or NeisVac-C as measured by rSBA. If this non-inferiority is demonstrated, then
  • the non-inferiority of the antibody response (GMT). If this non-inferiority is demonstrated, then
  • the superiority of the antibody response (GMT)

Secondary Objective:

To demonstrate:

  • the non-inferiority of the seroprotection rate (antibody titers 1:8) to meningococcal serogroup C following the administration of MenACYW conjugate vaccine or Nimenrix as measured by serum bactericidal assay using baby rabbit complement (rSBA). If this non-inferiority is demonstrated, then
  • the non-inferiority of the antibody response (GMT). If this non-inferiority is demonstrated, then
  • the superiority of the antibody response (GMT).

Or to demonstrate:

  • the non-inferiority of the seroprotection rate (antibody titers 1:8) to meningococcal serogroup C following the administration of MenACYW conjugate vaccine or NeisVac-C as measured by hSBA. If this non-inferiority is demonstrated, then
  • the non-inferiority of the antibody response (GMT). If this non-inferiority is demonstrated, then
  • the superiority of the antibody response (GMT) .

Detailed Study Description

Study duration per participant is approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety-follow up/end of study visit at Day 8 and Day 30 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) and adverse event of special interest (AESI) throughout the study.

Clinical Study Identifier: NCT03890367

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Recruitment Status: Open


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