10-year Follow-up After a Single Dose Acellular Pertussis Vaccination
Recruiting
Phase 4Interventional Study
Pertussis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Prevention
Participants needed
126 (estimated)
Sponsor
Mahidol University · Other
Who this trial is looking for
This trial is looking for participants who have taken part in an earlier study and received a vaccine. Participants will provide a blood sample and may receive a second booster dose of Pertagen® after ten years.
Are You a Good Fit for This Trial?
You may be able to join if
I participated in the initial study and completed the follow-up visit.
I am healthy according to my medical history and physical exam.
I can follow study procedures and give a blood sample.
I have a negative urine pregnancy test if I could become pregnant.
I will use reliable birth control for one month after vaccination.
You may not be able to join if
I have received any pertussis vaccine since the initial study follow-up.
I have had pertussis diagnosed by a doctor since the initial study.
I am pregnant or breastfeeding.
I have a history of significant medical illnesses that may affect safety.
I have allergies to any vaccine or its components.
I have had serious side effects from vaccines before.
I have received blood products or immunoglobulin in the last 3 months.
I have taken immunosuppressive drugs or corticosteroids in the last 3 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 (Ada…
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).
Trial Locations
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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 o…
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.
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