TNA ED50 and NF50 Geometric Mean Titers and 95% Confidence Intervals, Per Protocol Day 63 Population.
CI=confidence interval; ED50=50% effective dose; GMT=geometric mean titer; IM=intramuscular; NF50=50% neutralization factor; TNA=toxin neutralizing antibody.
The Per Protocol Population at Day 63 is all randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect vaccine dose at one or more visits; 4) vaccine dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data.
The horizontal line represents a TNA NF50 threshold of 0.56, established for BioThrax at Day 63.
The numbers of subjects analyzed are as follows:
Day 63: Group 1, 37 subjects; Group 2, 27 subjects; Group 3, 18 subjects; Group 4, 41 subjects; and Group 5, 21 subjects.
Day 28: Group 1, 37 subjects; Group 2, 27 subjects; Group 3, 18 subjects; Group 4, 41 subjects; and Group 5, 21 subjects.
Day 42: Group 1, 37 subjects; Group 2, 26 subjects; Group 3, 18 subjects; Group 4, 41 subjects; and Group 5, 20 subjects.