Pregnancy Related Clinical Trial
Official title:
Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibody Response After a Single Dose of Reduced-antigen, Combined Diphtheria, Tetanus, and Acellular Pertussis Vaccine (Tdap) in Pregnant Thai Women
This study evaluated the seroprevalence of Bordetella pertussis antibodies and anti-pertussis
antibody response after a single dose of reduced-antigen, combined diphtheria, tetanus, and
acellular pertussis vaccine (Tdap) in pregnant Thai women.
All seronegative participants received Tdap, while seropositive participants were equally
randomized into 2 groups. Half of seropositive participants received Tdap and the other half
received tetanus-diphtheria (Td) as standard protocol.
The primary objective of this study was to determine the seroprevalence of anti-pertussis toxin antibodies (anti-PT IgG) among pregnant Thai women. The secondary objectives were to evaluate antibody response after Tdap vaccination between seronegative and seropositive participants and to compare the different antibody titers at delivery among seropositive participants who received Tdap to those who received tetanus-diphtheria vaccine (Td). The sample size calculation was based on the primary objective. Randomized clinical trial was performed for the latter secondary objective. ;
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