NCT06803524 10-year Follow-up After a Single Dose Acellular Pertussis Vaccination
| NCT ID | NCT06803524 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mahidol University |
| Condition | Pertussis |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2025-05-13 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 126 participants in total. It began in 2025-05-13 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: A participant will be eligible for inclusion if ALL of the following apply at the time of screening: 1. 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; 2. Written informed consent is obtained prior to study entry; 3. Healthy, as established by pertinent medical history and physical examination; 4. Capable of complying with study procedures and willing to provide with a blood sample; 5. 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: A participant with following criteria at screening will not be eligible for participation: 1. Having received any pertussis vaccine since completion of 1-year follow-up visit in the initial TDA202 study; 2. Having experienced physician-diagnosed pertussis since completion of 1-year follow-up visit in the initial TDA202 study prior to enrollment; 3. Pregnant or breast-feeding women or female participants who intend to become pregnant during study period; 4. 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; 5. History of allergy or hypersensitivity to any vaccine (including its component); 6. History of any serious adverse event or neurological adverse event after vaccination; 7. History of receiving blood or blood component or immunoglobulin within 3 months prior to enrollment; 8. 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; 9. Having received any other vaccines within 28 days prior to enrollment (3 months for live- attenuated vaccines); 10. Plan to receive any other vaccine or plan to participate in another clinical trial with intervention during the study period; 11. A known bleeding diathesis or any condition that may be associated with a prolonged bleeding time resulting in a problem with intramuscular injection; 12. Any progressive or severe neurological disorder such as seizure disorder or Guillain-Barré syndrome; 13. History of any illness or clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the volunteers due to participation in the study 14. Fever as defined by body temperature ≥ 38°C at the time of enrollment (This is a temporary exclusion criterion). Remark: If fever occurs at screening visit, the participant may be rescreened and enrolled at a later date at the discretion of the investigator, or withdrawn at the discretion of the investigator.
Contact & Investigator
Punnee Pitisuttithum
PRINCIPAL INVESTIGATOR
Vaccine trial Centre
Frequently Asked Questions
Who can join the NCT06803524 clinical trial?
This trial is open to participants of all sexes, studying Pertussis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06803524 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06803524 currently recruiting?
Yes, NCT06803524 is actively recruiting participants. Contact the research team at punnee.pit@mahidol.ac.th for enrollment information.
Where is the NCT06803524 trial being conducted?
This trial is being conducted at Bangkok Noi, Thailand, Ratchathewi, Thailand.
Who is sponsoring the NCT06803524 clinical trial?
NCT06803524 is sponsored by Mahidol University. The principal investigator is Punnee Pitisuttithum at Vaccine trial Centre. The trial plans to enroll 126 participants.