U.S., March 22 -- ClinicalTrials.gov registry received information related to the study (NCT06888076) titled 'Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Pregnant Women' on March 12.
Brief Summary: This is an observational, retrospective, cohort, safety study in pregnant women (vaccinated with Pertagen(R)) and have given birth in Thailand from January 2021 to April 2024 and infants born to pregnant women who received Pertagen(R).
Following approval of the final protocol from the Institutional Review Board (IRB) and/or Ethics Committee (EC) and written approval from hospital directors/medical doctors as per requirements of each institutions. The assigned Ob-gyn specialist/physician at each study site will re...