Status:
COMPLETED
3-year Follow-up After a Single Dose Acellular Pertussis Vaccination
Lead Sponsor:
Mahidol University
Conditions:
Pertussis
Eligibility:
All Genders
Brief Summary
In July 2015-November 2016, a phase II/III randomized, observer-blind,controlled study of two acellular Pertussis vaccines (aP standalone and TdaP combined vaccined) manufactured by BioNet-Asia Co., L...
Detailed Description
The study population will included all subjects who participated in the TDA202 study at the Vaccine Trial Centre (VTC), Faculty of Tropical Medicine, Mahidol University, Bangkok. The subjects who had...
Eligibility Criteria
Inclusion
- Having participated in TDA202 study, received a single dose of one of the 3 study vaccines, and completed 1 year follow-up visit.
- Written informed consent is obtained for subjects aged ≥18 years, or written assent and written informed consent are obtained from subjects aged \<18 years and from their parent/legal guardian, respectively, prior to study entry.
- Capable to comply with study procedures and willing to provide with a blood sample.
Exclusion
- No exclusion criteria for this study. Subjects will be eligible for participation if all inclusion criteria are met.
Key Trial Info
Start Date :
June 26 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 27 2018
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT04102137
Start Date
June 26 2018
End Date
August 27 2018
Last Update
October 1 2019
Active Locations (1)
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1
Vaccine Trial Centre, Faculty of Tropical Medicine, Mhahidol University, 420/6 Ratchawithi Road, Ratchathewi,
Bangkok, Thailand, 10400