Status:
COMPLETED
2-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. This is further foll...
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
- Received lived attenuated vaccine within 3 months prior to participating in this study.
- Received vaccines other than lived attenuated vaccine within 28 days prior to participating in this study.
- History of receiving blood or blood component or immunoglobulin within 3 months prior recruitment
- History of receiving immunosuppressive drugs or systemic corticosteroid (\>0.5 mg/kg of prednisolone or equivalent for more than 14 days) within 3 months prior to recruitment.
- Received diphtheria or tetanus or pertussis vaccine within 1 year prior to inclusion in the present study.
Key Trial Info
Start Date :
June 20 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2017
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04113655
Start Date
June 20 2017
End Date
July 31 2017
Last Update
October 3 2019
Active Locations (2)
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1
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi,
Bangkok, Thailand, 10400
2
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,
Bangkok, Thailand, 10400