Actively Recruiting
10-year Follow-up After a Single Dose Acellular Pertussis Vaccination
Led by Mahidol University · Updated on 2025-06-11
126
Participants Needed
2
Research Sites
41 weeks
Total Duration
On this page
Sponsors
M
Mahidol University
Lead Sponsor
B
BioNet-Asia Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
10-year Follow-up After a Single Dose Acellular Pertussis Vaccination
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participated in the initial TDA202 study, received one dose of any of the 3 study vaccines, and completed the 1-year follow-up visit
- Provided written informed consent before joining the study
- Are healthy based on medical history and physical exam
- Able to follow study procedures and willing to give blood samples
- For women with childbearing potential, have a negative pregnancy test at enrollment and agree to use reliable birth control for one month after vaccination
You will not qualify if you...
- Received any pertussis vaccine after completing the 1-year follow-up in the initial TDA202 study
- Diagnosed with pertussis by a doctor after completing the 1-year follow-up in the initial TDA202 study
- Are pregnant, breastfeeding, or plan to become pregnant during the study
- Have significant medical illnesses affecting immune function or other major organ systems that could impact safety or study results
- Have a history of allergy or severe reaction to any vaccine or its components
- Experienced serious or neurological adverse events after vaccination
- Received blood, blood components, or immunoglobulin within 3 months before enrollment
- Used immunosuppressive drugs or systemic corticosteroids at doses greater than 0.5 mg/kg for over 14 days within 3 months before enrollment
- Received any other vaccines within 28 days before enrollment (or 3 months for live vaccines)
- Plan to receive other vaccines or participate in other clinical trials during this study
- Have known bleeding disorders that could affect intramuscular injection
- Have progressive or severe neurological conditions such as seizure disorder or Guillain-Barr� syndrome
- Have any illness or condition that could interfere with study results or participant safety
- Have a fever (temperature ed 386C) at enrollment (may be rescreened later if fever resolves)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok Metropolis, Thailand, 10700
Actively Recruiting
2
Vaccine Trial Centre
Ratchathewi, Bangkok Metropolis, Thailand, 10400
Actively Recruiting
Research Team
P
Punnee Pitisuttithum
CONTACT
J
Jittima Dhitavat
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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