Statistical analysis
SECONDARY
The sample size was calculated based on non-inferiority test with a significance level of 0.00625 for the primary objective after a Bonferroni adjustment. In order to have sufficient sample size to conduct the primary analysis, we pooled both pregnant women (80 enrolled per group; 400 in total) recruited in the current study and non-pregnant women of childbearing age from the previous study (50 enrolled per group; 250 in total) The power to show comparability of immune response in terms of anti-PT GMCs 28 days after a single dose with study vaccine versus comparator was calculated using a one-sided two-sample With 80 pregnant women vaccinated per group, the present study had a 95% probability to detect at least one SAE if the true incidence is 3.7%. Conversely, if no SAEs were observed in 80 vaccine recipients, the study would be able to rule out SAEs occurring at a rate of approximately 4.6% or above, based on the upper bounds of the 95% CI.To assess the primary outcome, GMC of anti-PT antibody at 28 days following immunization in pregnant women and women of childbearing age The secondary endpoints, GMC of anti-PT, anti-FHA, anti-tetanus and anti-diphtheria, and GMT of PT neutralizing antibody at baseline and 28 days following immunization in pregnant women, were calculated for each vaccine group along with two-sided 95% CI. The ratio of the GMC or GMT in each of the ap1For safety analysis, the proportion of participants with safety endpoints at different study time points along with an exact two-sided 95% CI were calculated using the Clopper-Pearson method. A pair-wise comparison in the percentage of participants with safety endpoints between each of the ap1All statistical analyses were performed using SAS® software version 9.4.