Pneumococcus For Japanese Investigators only. Regional AOI included. The following areas are of interest to Merck Investigator Studies Program Committee: Global AOI • Development and/or assessment of non-invasive diagnostic methods to reliably identify pneumococcal serotypes causing disease, with particular focus on non-bacteremic pneumonia in adults, and acute otitis media and pneumonia in infants. o Pathogenesis: Studies in a suitable animal model to investigate the factors associated with the pathogenesis of pneumococcal disease (invasive and noninvasive) in the setting of pneumococcal carriage. Identification of pneumococcal molecular determinants associated with pneumococcal disease in the context of co-infection with other viral or bacterial pathogens as well as other conditions associated with increased risk for pneumococcal disease. • In vitro or modest (small scale) nonhuman primate studies investigating the role of plasma cells and /or memory B cells (other than from peripheral blood) for the efficacy of pneumococcal polysaccharide or conjugate vaccines. • Small-scale studies to evaluate the role of novel delivery devices to enhance the immunogenicity of pneumococcal vaccines in adults. Regional AOI for Japan • Real world effectiveness studies that assess population impact after a PPV23 routine immunization program • Studies that include sequential dosing of PCV13 and PPV23 that evaluate immunoglobulin G(IgG), and opsonophagocytic activity • Studies evaluating the immunogenicity and safety of concomitant vaccination of PPV23 and influenza vaccines Merck Investigator Studies Programsサイト(クリックすると、Merck & Co., Incが運営する米国MISP ウェブサイトのAOI情報へジャンプします。 ) Regional AOIは、その地域のニーズを取り入れて設定された独自のAOIです。 Regional AOIの申請手順/スケジュール/審査委員会は、Global AOIと同じです。 日本の申請窓口はMSD株式会社となります。申請をご検討の場合は、お早めに問い合せ/資料請求 先へ申請資料をご請求ください。 以上
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