Safety and immunogenicity of a quadrivalent meningococcal polysaccharide vaccine (MPV ACYW135) compared with a quadrivalent meningococcal conjugate vaccine (Menactra ® ): a study protocol of a randomized non-inferiority trial in Mali

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Abstract A phase IV clinical trial is designed to compare the safety and immunogenicity of a quadrivalent meningococcal polysaccharide vaccine (Walvax MPV ACYW135) compared with a quadrivalent meningococcal conjugate vaccine (Sanofi Pasteur Menactra ® ) in children aged 2-10 years in Mali, a country within the meningitis belt, to demonstrate the benefit that might be brought by vaccinations with meningococcal polysaccharide vaccines. Eligible subjects will be randomized at a 1:1 ratio to receive either Walvax MPV ACYW135 or Sanofi Pasteur Menactra ® . All subjects will be followed up for solicited/unsolicited adverse events and any serious adverse events. Immunogenicity will be determined with the level (titer) of functional antibodies by serum bactericidal assay using baby rabbit complement (rSBA) with non-inferiority demonstrated. Clinical Trial Registration NCT04450498

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