Clinical Research Directory

Phase I/II Clinical Trial of Diphtheria-Tetanus-Pertussis (Reduced Dose) Vaccine

This is a randomized, double-blinded, parallel-controlled phase I/II clinical trial to evaluate the safety and preliminary immunogenicity of the Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (reduced antigen content) in subjects aged 6 years and above.

Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Pregnant Women

This is an observational, retrospective, cohort, safety study in pregnant women (vaccinated with Pertagen®) and have given birth in Thailand from January 2021 to April 2024 and infants born to pregnant women who received Pertagen®. 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 review the medical record of pregnant women (January 2020 to April 2024) based on study selection criteria. Safety information of pregnant women who received Pertagen® and have given birth from January 2021 to April 2024 and infants born to pregnant women who received Pertagen® will be obtained from medical records in hospitals/clinics and will be reported in case report form (CRF) by assigned Ob-gyn specialist/physician at each study site. The assigned Ob-gyn specialist/physician at each study site who will review the medical records and report the data in case report form (CRF) is not part of the research team.

A Phase 4, Randomised Vaccination Study in Healthy Adults to Investigate the Effects of Acellular Pertussis Vaccine on Colonisation with Bordetella Pertussis Using Controlled Human Infection

The goal of this clinical trial is to investigate the effect of booster vaccination with acellular pertussis vaccine on colonization with Bordetella pertussis using a controlled human infection model in healthy volunteers. The main questions it aims to answer are: * Whether booster vaccination with Tdap-IPV reduces Bp colonisation after intranasal challenge with the standard Bp inoculum dose compared to the Td-IPV control group * Compare Bp colonisatation in participants vaccinated with Tdap-IPV after intranasal challenge with the standard and a 'high' Bp inoculum dose Research will compare Tdap-IPV vaccination - standard inoculum dose with Td-IPV vaccination - standard inoculum dose, and Tdap-IPV vaccination - standard inoculum dose with Tdap-IPV vaccination - high inoculum dose to see how Tdap-IPV vaccination and the high inoculum dose have an effect on colonisation rate. Participants will be vaccinated with Tdap-IPV or Td-IPV and 2-4 months later challenged with the standard or 'high' inoculum. After challenge there is a follow up visit for 28 days in which they fill in a daily symptom diary and have 6 visits to the hospital.