Other endpoint analysis at Day 28 post-vaccination in pregnant women only
diphtheria, tetanus, preterm labor
DIPHTHERIA, TETANUS, VAGINAL BLEEDING, PRETERM LABOR
At baseline, the GMC of anti-PT antibody was low and similar in all maternal vaccine groups. On Day 28, the anti-PT antibody GMC change from baseline was highest for the TdaP5Similarly, at baseline, the GMT of PT neutralizing antibody was low and similar in all groups. On Day 28, the GMT change from baseline was highest for the TdaP5The GMC of anti-FHA antibody at baseline was similar in all groups. On Day 28, the change in GMC from baseline was highest in the Tdap8The proportion of pregnant women with ≥ 4-fold increase in antibody concentration to PT and FHA at Day 28 with respect to baseline (seroconversion rates) ranged from 76.9% to 97.4% for PT in Tdap8Anti-PT IgG, anti-FHA IgG, and PT-neutralizing antibody seroresponse rate and anti-TT IgG, anti-DT IgG seroprotection rate at 28 days after vaccination in pregnant women.For PT neutralizing antibody, the seroconversion rate was 100% for TdaP5Reverse cumulative distribution curves (RCDCs) for anti-PT IgG, anti-FHA IgG, and PT neutralizing antibody at baseline and Day 28 after vaccination are shown in Participants vaccinated with the formulations containing tetanus (TT) and diphtheria (DT) toxoid antigens all showed satisfactory tetanus and diphtheria responses at Day 28, and the anti-TT and anti-DT antibody GMC changes from baseline were similar for all vaccines. The anti-TT and anti-DT responses elicited by the study vaccines were similar to those elicited by the comparator, Tdap8The TT antibody concentration was ≥0.1 IU/mL (equated with seroprotection) in more than 96% of participants at baseline, rising to 100% by Day 28. For DT, the proportion of participants with antibody concentration ≥0.1 IU/mL (equated with seroprotection) was doubled from 46%, rising to 92% by Day 28 after vaccination (The solicited local and systemic reactions are presented in A total of 120 unsolicited AEs were reported by 20.3% of participants up to Day 28 following vaccination (Overall, five SAEs (four cases of preterm labor and one case of vaginal bleeding) were reported up to Day 28 following vaccination. None of these SAEs were considered vaccine-related (