Extended Data Table 3 Summary of anti-tetanus neutralizing antibody ΔTiters level after study drug administration in participants with baseline antibody titers <0.01 IU/mL

From: Recombinant monoclonal antibody siltartoxatug versus plasma-derived human tetanus immunoglobulin for tetanus: a randomized, double-blind, active-controlled, phase 3 trial

  1. CI, confidence interval.
  2. The baseline titers and the ΔTiters (increase of titers from baseline) at different time points are presented as the geometric mean (% coefficient of variation).
  3. The ΔTiters for the siltartoxatug group were calculated as the post-administration antibody titers minus the baseline antibody titers, measured using the TNM002 PD bioanalytical method. Similarly, the ΔTiters for the HTIG group were calculated based on antibody titers measured by the HTIG PD bioanalytical method.
  4. For tertiary efficacy endpoint analyses, participants who concomitantly received the tetanus vaccine in the siltartoxatug group (n = 47) and HTIG group (n = 24) were excluded to avoid interference.
  5. The proportion of participants with ΔTiters ≥0.01 IU/mL were calculated, and the corresponding 95% CI was constructed using the Clopper–Pearson method. A 95% CI for intergroup difference was calculated using Miettinen–Nurminen method. A mixed-effect model for repeated measures was used to compare and analyze ΔTiters between groups at each scheduled time point. All tests were two-sided. No adjustments were made for multiple comparisons.
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