Fig. 4.

(a) Per protocol Non-inferiority Evaluation of Liquid-SC vs. Lyophilized-SC 97.5% confidence interval (CI) for the log 2 difference in the geometric means of the peak titers (GMT) for the Liquid-SC and Lyophilized-SC group. The black circles mark the point estimate of the difference and the bars mark the upper and lower limits of the 97.5% CI. The dotted black line marks the non-inferiority margin. The grey dashed line marks a zero difference. If the circle is to the right of the grey dashed line, Liquid SC has higher GMTs than the Lyophilized SC group; if the circle is to the left of the dashed line, Liquid SC has lower GMTs than the Lyophilized SC group. For all assays, the Lyophilized SC group obtained higher GMTs. As the upper bounds of the CIs were below 1 (to the left of the black dotted non-inferiority margin), non-inferiority was established. As the upper bound was also below 0 (grey dashed line) for SLU PRNT₆₀, BN PRNT₅₀, and BN ELISA, for these assays, the Lyophilized-SC group was superior to the Liquid-SC group. (b). Per protocol Non-inferiority Evaluation of Liquid-SC vs. Liquid-ID 97.5% confidence interval (CI) for the log2 difference in the geometric means of the peak titers (GMT) for the Liquid-SC and Liquid-ID group. As the upper bounds of the CIs were below 1 (to the left of the black dotted non-inferiority margin), non-inferiority was established. Superiority was not established for any assay as the upper bounds of the CIs were not below 0 (grey dashed line).