10-year Follow-up After a Single Dose Acellular Pertussis Vaccination (NCT06803524) | Clinical Trial Compass
RecruitingPhase 4
10-year Follow-up After a Single Dose Acellular Pertussis Vaccination
Thailand126 participantsStarted 2025-05-13
Plain-language summary
This is a phase IV, open-label, non-randomized study to demonstrate superior immunogenicity and safety of a second booster dose of Pertagen® as compared to Adacel® at 10 years after the first booster vaccination and to evaluate the long-term persistence of specific antibodies induced by BioNet's recombinant aP (Pertagen®) and TdaP (Boostagen®) vaccines and a chemically-detoxified Tdap vaccine (Adacel®) at 10 years after the first booster in participants who were vaccinated in the phase II/III trial (Protocol No. TDA202).
Who can participate
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Inclusion criteria
âś“. 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;
âś“. Written informed consent is obtained prior to study entry;
âś“. Healthy, as established by pertinent medical history and physical examination;
âś“. Capable of complying with study procedures and willing to provide with a blood sample;
âś“. For women with childbearing potential (i.e., urine pregnancy test will not be performed in females who have undergone sterilisation, hysterectomy or who are post-menopausal), must have a negative urine pregnancy test at enrollment and willing to take reliable birth control measures for one month following vaccination.
Exclusion criteria
âś•. Having received any pertussis vaccine since completion of 1-year follow-up visit in the initial TDA202 study;
âś•. Having experienced physician-diagnosed pertussis since completion of 1-year follow-up visit in the initial TDA202 study prior to enrollment;
âś•. Pregnant or breast-feeding women or female participants who intend to become pregnant during study period;
âś•. History of any significant medical illness such as, but not limited to, immune deficiency, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic, renal, or endocrine disorder, splenic or thymic functional abnormality as determined by the investigator based on medical history and physical examination that may interfere with the participant's safety and evaluation of investigational vaccines in this study;
What they're measuring
1
To demonstrate superiority at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.
âś•. History of allergy or hypersensitivity to any vaccine (including its component);
âś•. History of any serious adverse event or neurological adverse event after vaccination;
âś•. History of receiving blood or blood component or immunoglobulin within 3 months prior to enrollment;
âś•. 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 enrollment;