Antipalivizumab antibody analyses were performed at PPD (Richmond, VA, USA) using a validated enzyme-linked immunosorbent assay (ELISA) (developed by MedImmune) . Caspase Inhibitor VI supplier Controls were prepared by adding a goat polyclonal antipalivizumab antibody into normal human serum. Duplicate determinations of the positive control and negative controls were performed. Results were analyzed using Softmax Pro 4.8 software (Molecular Devices Corporation. Sunnyvale, CA, USA). Positive Go6983 unknown samples were titered on a second plate beginning with the original sample and diluting 1:2 with normal human serum across
the plate in duplicate. The endpoint titer was defined as the highest serum dilution tested that showed a positive response. The lowest dilution value for which a positive result could be obtained was 1:10 because all samples were diluted 1:10 before performing the assay. Statistical Analyses The safety PF-6463922 chemical structure analysis included all subjects who received any study medication. The ADA analysis included subjects who received ≥2 doses of study medication and had ≥1 blood
sample collected. The sample size calculation was based on findings from the pivotal phase 3 study , which showed approximately 1% detection of ADA after a single season of dosing with lyophilized palivizumab. A sample size of 200 per treatment group was chosen so that the upper limit of the 95% confidence interval (CI) would be below 3%. Categorical data were summarized by the number and percent of subjects in each category. To determine the percent positive ADA, 95% CIs were also calculated. No formal
tests of comparison were planned or conducted. Statistical analyses were conducted using the SAS® System software version 6.12 and/or 8.2 for Windows, or higher (SAS Institute, Inc., Cary, NC, USA). Results Subjects A total of 417 subjects were randomized into the study across the 51 sites in the United States, and 413 subjects were followed and included in all of the safety analyses; 4 subjects from 1 site were excluded from the analyses because the site did not provide any additional information PAK5 or data regarding the subjects other than the fact that they received all 5 doses of palivizumab. Of the 413 subjects, 211 were randomized into the liquid palivizumab group and 202 were randomized into the lyophilized palivizumab group. Overall, 26/413 (6.3%) subjects did not complete the study. The most common reasons for not completing the study were lost to follow-up [14/413 (3.4%)] and withdrawal of consent [8/413 (1.9%); Fig. 1]. Demographic and baseline characteristics, including age, gender, race, and weight, were similar between the liquid and lyophilized palivizumab groups (Table 1). Fig. 1 Disposition of subjects.