8%; lyophilized, 1.5%). The ADA results in the present and previous studies were based on positive palivizumab

antibodies using an ELISA, which is limited in its ability to detect antipalivizumab antibodies in the presence of palivizumab [4]. In the present study, the true ADA percent positive for both treatment groups combined based on the upper limit of the 95% CI was at most 1.5%. The 0.5% observed ADA percent positive (with an upper limit of the 95% CI of 2.9%) for lyophilized palivizumab reported in the present study was consistent with the 1.2% observed ADA percent positive reported in a previous phase 3 trial of lyophilized palivizumab in 1,502 children [6]. In another previous trial of high-risk preterm children ≤24 months of age, the ADA percent positive was 0.3% for both palivizumab formulations combined C59 [4]. It is possible that the ADA percent positive in both study arms of the present study could have been selleck chemicals llc higher had the current drug-tolerant electrochemiluminescence (ECLA) assay been used. However, 2 studies of liquid palivizumab recipients that used an ECLA to determine ADA also demonstrated ADA percents positive

of 1.1% and 1.5% [4]. Acknowledgments This study and article publication charges were funded by MedImmune. Medical writing and editorial assistance, provided by John E. Fincke, Ph.D., and Anny Wu, Pharm.D., of Complete Healthcare Communications, Inc. (Chadds Ford, PA, USA), was supported by MedImmune. All named authors meet the ICMJE criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. Conflict of interest Doris Makari is an employee of MedImmune and may have stock or stock options in AstraZeneca, the parent company of MedImmune. Kathryn M. Jensen is an employee of MedImmune and may have stock or stock options in AstraZeneca, most the parent company of MedImmune. Brian Harris is an employee of MedImmune and may have stock or stock options in AstraZeneca, the parent

company of MedImmune. Hasan S. Jafri is an employee of MedImmune and may have stock or stock options in AstraZeneca, the parent company of MedImmune. Compliance with ethics guidelines All study procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as LXH254 price revised in 2000 and 2008. Informed consent was obtained from all patients for being included in the study. Open Access This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.