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FDA Approves New Meningococcal Disease Vaccine NEW YORK -- February 22, 2010 -- The US Food and Drug Administration (FDA) has approved a Meningococcal (groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (Menveo) for active immunisation to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in people aged 11 to 55 years. The approval was based on a phase 3 head-to-head clinical trial that compared the new vaccine to the other US-licensed ACWY meningococcal conjugate vaccine among individuals aged 11 to 55 years. The trial, which was broken into 2 subsets -- adolescents aged 11 to 18 years and adults aged 19 to 55 years -- measured for each of the 4 serogroups both the percentage of subjects who achieved an immune response as measured by seroresponse and proportions achieving human serum bactericidal antibody (hSBA) titers >=1:8. In addition, the study examined antibody level as measured by geometric mean titers (GMT). The new vaccine met its primary endpoint for all 4 serogroups using hSBA seroresponse. The percentages of subjects who demonstrated an immune response for each serogroup for the vaccine and its comparator, respectively, were: Serogroup A - 75: 67; serogroup C - 84: 84; serogroup Y - 88: 69; and serogroup W-135 - 96: 88. In the same group, the levels of circulating antibodies in those who received the new vaccine versus those who received the comparator, respectively, were: Serogroup A - 29: 18; serogroup C - 59: 47; serogroup Y - 51: 18; and serogroup W-135 - 87: 44. SOURCE: Novartis E-mail this page to a friend or colleague! To print, use this version