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New treatment option for Pertussis
Official title 10-year Follow-up After a Single Dose Acellular Pertussis Vaccination
ClinicalTrials.gov ID: NCT06803524
What this study is testing
What is Pertagen® vaccine?
Pertagen® vaccine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pertussis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults. Healthy volunteers may be eligible.
You may be able to join if
- A participant will be eligible for inclusion if ALL of the following 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 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;
You likely can't join if
- A participant with following criteria at screening will not be eligible for participation:
- Having received any pertussis vaccine since completion of 1-year follow-up visit in the initial TDA202 study;
- Having experienced physician-diagnosed pertussis since completion of 1-year follow-up visit in the initial TDA202 study prior to enrollment;
- Pregnant or breast-feeding women or female participants who intend to become pregnant during study period;
- History of any significant medical illness such as, but not limited to, immune deficiency, clinically significant psychiatric, hematologic...
- History of allergy or hypersensitivity to any vaccine (including its component);
See the full eligibility criteria
- A participant will be eligible for inclusion if ALL of the following 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 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;
- 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...
- A participant with following criteria at screening will not be eligible for participation:
- Having received any pertussis vaccine since completion of 1-year follow-up visit in the initial TDA202 study;
- Having experienced physician-diagnosed pertussis since completion of 1-year follow-up visit in the initial TDA202 study prior to enrollment;
- Pregnant or breast-feeding women or female participants who intend to become pregnant during study period;
- 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...
- History of allergy or hypersensitivity to any vaccine (including its component);
- History of any serious adverse event or neurological adverse event after vaccination;
- History of receiving blood or blood component or immunoglobulin within 3 months prior to enrollment;
- 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;
- Having received any other vaccines within 28 days prior to enrollment (3 months for live- attenuated vaccines);
- Plan to receive any other vaccine or plan to participate in another clinical trial with intervention during the study period;
- A known bleeding diathesis or any condition that may be associated with a prolonged bleeding time resulting in a problem with intramuscular injection;
- Any progressive or severe neurological disorder such as seizure disorder or Guillain-Barré syndrome;
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bangkok Noi, Bangkok Metropolis, Thailand
- Ratchathewi, Bangkok Metropolis, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bangkok Noi, Bangkok Metropolis, Thailand; Ratchathewi, Bangkok Metropolis, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.