Trial reportHuman vaccines & immunotherapeutics2023
Safety and immunogenicity of quadrivalent meningococcal polysaccharide vaccine (MPV ACYW135) compared with quadrivalent meningococcal conjugate vaccine (Menactra®) in Malian children.
Trial report in Human vaccines & immunotherapeutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04450498 (A Phase IV Randomized, Observer-blind, Controlled Study to Demonstrate Non-inferior Immunogenicity of Yuxi Walvax MPV ACYW® Vaccine as Compared to Sanofi Pasteur Menactra® Vaccine in Healthy Subjects Aged 2-10 Years), which is not on this map. Not yet cited in PubMed.
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A Phase IV Randomized, Observer-blind, Controlled Study to Demonstrate Non-inferior Immunogenicity of Yuxi Walvax MPV ACYW® Vaccine as Compared to Sanofi Pasteur Menactra® Vaccine in Healthy Subjects Aged 2-10 Years
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18 authors at 6 institutions in 5 countries.
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No grant is acknowledged in the PubMed record.
Abstract
Affordable, polyvalent meningococcal vaccines are needed for use in emergency reactive immunization campaigns. A phase IV randomized, observer-blind, controlled study compared the safety and immunogenicity of a quadrivalent meningococcal polysaccharide vaccine (MPV-4, MPV ACYW135) and quadrivalent meningococcal ACWY conjugate vaccine (MCV-4, Menactra®). Healthy, 2- to 10-year-old children in Bamako, Mali, were randomized 1:1 to receive one dose of MPV-4 or MCV-4. Safety outcomes were evaluated for 6 months post-immunization. Immunogenicity for all serogroups was assessed for non-inferiority between MPV-4 and MCV-4 30 days post immunization by serum bactericidal antibody assay using baby rabbit complement (rSBA). From December 2020 to July 2021, 260 healthy subjects were consented and randomized. At Day 30 post-immunization, the proportions of subjects with rSBA titers ≥ 128 for all serogroups in the MPV-4 group were non-inferior to those in MCV-4 group. The proportions of subjects with rSBA ≥ 4-fold increase and rSBA titers ≥ 8 for all serogroups were similar among vaccine groups (
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