Status:
COMPLETED
5-year Follow-up After a Single Dose Acellular Pertussis Vaccination
Lead Sponsor:
Mahidol University
Collaborating Sponsors:
BioNet-Asia Co., Ltd.
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 vaccines) manufactured by BioNet-Asia Co., L...
Detailed Description
The study population will included all participants who participated in the TDA202 study at the Vaccine Trial Centre (VTC), Faculty of Tropical Medicine, Mahidol University, Bangkok. Participants fro...
Eligibility Criteria
Inclusion
- A participant will be eligible for inclusion if ALL of the followings apply at the time of screening:
- Having participated in the initial 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 participants aged ≥18 years, or written informed consent are obtained from participants aged \<18 years with their parents/legal guardians, co-signed prior to study entry;
- Healthy, as established by pertinent medical history and physical examination;
- Capable of complying with study procedures and willing to provide with a blood sample
Exclusion
- 1\. Having received pertussis vaccine since TDA202 study
Key Trial Info
Start Date :
August 24 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 3 2021
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT04529720
Start Date
August 24 2020
End Date
November 3 2021
Last Update
January 5 2022
Active Locations (1)
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1
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi,
Bangkok, Thailand, 10400