However, the lower responses were still within the 2-fold GMC criterion for noninferiority for all pneumococcal serotypes, with the exception of 19F, which
was just below the noninferiority margin. The lower immune response Selleckchem Idelalisib observed by concomitant administration of these vaccine antigens is not easily understood. Such interactions are thought to be caused by complex, multi-factorial interactions, including antigen competition, and the effects of other vaccine components on the immune response [23]. A possible mechanism could be that vaccine antigens interfere with the MHC class I and II antigen processing and presentation pathways, leading to a uniformly reduced response to PCV13 serotypes [24]. Further research is required to better understand this phenomenon. Local reactions at the PCV13 injection site were comparable. Although systemic events were more common after PCV13 + TIV relative to TIV or PCV13 alone, this is probably because of the additive effects of both TIV and PCV13 systemic events. Overall, fever rates were low, and there were no DZNeP vaccine-related SAEs during the study. Although immune responses to vaccine antigens were
observed after receipt of both vaccines, the lack of knowledge about the threshold level of antibodies needed to protect against pneumococcal disease in adults is a limitation of the study. The results from the efficacy study of PCV13 being conducted in adults aged ≥65 years in The Netherlands are awaited to help establish an effective antibody level against pneumococcal disease in adults [12].
Overall, the Unoprostone concomitant administration of PCV13 and TIV was demonstrated to be immunogenic and safe. If PCV13 is determined to add value in a comprehensive immunization strategy against pneumococcal disease, the ability to coadminister PCV13 and TIV would facilitate the immunization of older adults. Financial support. This study was funded by Pfizer Inc. Pfizer was involved in the study design, data collection, data analysis, data interpretation, writing of the manuscript, and the decision to submit the paper for publication. Nancy Price at Excerpta Medica provided assistance in preparing and editing the manuscript, which was funded by Pfizer Inc. All authors had full access to all data. Potential conflicts of interest. T.F.S. has received honoraria from Pfizer, GlaxoSmithKline, and Novartis for conducting clinical trials and lecturing, and has participated as a member of advisory boards. J.F., H.C.R., and J.P. have no conflicts to report. C.J., A.W., D.J., P.G., E.A.E., W.C.G., and B.S-T are current or former employees of Pfizer Inc. Author contributions: C.J., E.A.E, W.C.G., and B.S-T participated in the conception and design, acquisition of data, analysis, and interpretation of the study; the writing of the report; and critically revising it for important intellectual content, and approved the final version to be submitted. T.F.S., J.F., H.C.R., and J.