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| |  Quadrivalent Meningococcal Conjugated Vaccine Well Tolerated, Immunogenic in Children Aged 2 to 10 Years: Presented at ESPID By Lynda Jackson BRUSSELS, Belgium -- June 14, 2009 -- The investigational quadrivalent (A, C, W-135, Y) meningococcal CRM197-conjugated vaccine (MenACWY-CRM) is well tolerated and immunogenic in children aged 2 to 10 years, with evidence of persistence of bactericidal antibodies for at least 6 months post vaccination, researchers stated here at the 26th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). On June 11, Michael Broeker, MD, Novartis Vaccines and Diagnostics GmbH & Co KG, Marburg, Delaware, presented the results of a study comparing MenACWY-CRM with a quadrivalent meningococcal (unconjugated) polysaccharide vaccine in children from Argentina, on behalf of Silvia González Ayala, MD, Servicio de Infectologia, Hospital de Niños Sor Maria Ludovico, La Plata, Argentina. “The study shows children aged 2 to 10 years immunised with the investigational conjugated vaccine displayed evidence of persistent immunogenicity against meningococcal disease,” said Dr. Broeker. A total of 1,500 healthy children aged 2 to 10 years were randomised 2:1 to received either MenACWY-CRM or the polysaccharide unconjugated vaccine. The study group collected immunogenicity, local, and systemic reaction data and serious adverse events for 6 months post vaccination. Using an exogenous human complement source (hSBA) assay, responders were defined as post-vaccination hBSA titres >=1.8 with baseline hSBA titres <1.4 or post-vaccination hBSA titres >=4 times of baseline titres >=1.4. At 1 month, hSBA geometric mean titres (GMTs) for all serogroups increased in both vaccine groups. However, children immunised with MenACWY-CRM experienced significantly higher seroresponses (P = .004)) compared with children who received the unconjugated vaccine. At 6 months, hSBA GMTs of all 4 subgroups decreased in all children, but titres remained higher for serogroups C, W135, and Y in children who received the MenACWY-CRM. Thus, a persistent antibody response was evident at 6 months post vaccination in more children who received MenACWY-CRM compared with those who received the unconjugated vaccine, said Dr. Broeker. The response was persistent in all MenACWY-CRM serogroups and children vaccinated with the conjugate vaccine maintained a higher hSBA titre against serogroups C, W135, and Y. [Presentation title: Safety and Immunogenicity of Novartis Vaccines’ Investigational Quadrivalent Meningococcal Conjugate Vaccine, MENACWYCRM Versus Menomune in Children Aged 2-10 Years. Abstract P509]
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