PertussisPhase 4NCT06803524
10-year Follow-up After a Single Dose Acellular Pertussis Vaccination
A Phase 4 study testing Pertagen® vaccine and Adacel® vaccine in people with Pertussis, run by Mahidol University at 2 sites in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pertussis
- What is being tested?
- Pertagen® vaccine and Adacel® vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesThailand
- Study dates
- 13 May 2025to 9 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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 enrollment and willing to take reliable birth control measures for one month following vaccination.
Who cannot join
- 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 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;
- History of allergy or hypersensitivity to any vaccine (including its component);
Show all 16Show fewer
- 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 at the discretion of the investigator, or withdrawn at the discretion of the investigator.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok Metropolis, 10700
Vaccine Trial Centre
Ratchathewi, Bangkok Metropolis, 10400
About this study
Official title: Antibody Persistence and Safety and Immunogenicity of a Second Booster Dose 10 Years After a First Booster Vaccination With a Single Dose Vaccination of aP Vaccine in Adults: A Phase IV, Open-label, Non-randomized, Follow-up Study
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).
Read the detailed description
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) conducted from July 2015 to November 2016. Only those who were enrolled in the initial TDA202 study and had completed TDA202 1-year follow-up will be recruited for this 10-year follow-up study.
Participants from all 3 vaccine groups (i.e., participants who had received a single dose of one of the 3 study vaccines (Boostagen®, Pertagen®, or Adacel®) and completed 1-year follow-up visit at Day 336±28 days during the TDA202 study will be called in for informed consent process at Visit 0 (Screening) at approximately 10 years (range, 9.5-10 years) following vaccination.
At Visit 0, Screening visit, participants who have signed the written Informed Consent Forms will be screened for general health status (medical history, medication history, immunization history, history of receiving blood, blood component, immunoglobulin, immunosuppressive drugs or systemic corticosteroid, vital signs and physical examination) and those who fulfill the pre-defined inclusion criteria without meeting any exclusion criteria will be enrolled into the study. The screening visit and Visit 1 (Day 0) can be completed on the same day. Once enrolled, a blood sample (approx. 5 mL) will be taken from all participants at Visit 1 (before second booster vaccination) and at Visit 2 (28 days after second booster vaccination) as shown in the diagram below (Figure 1).
At Visit 1, Day 0 (enrollment and second booster vaccination), a blood sample (approx. 5 mL) will be taken from all enrolled participants. After blood collection, the participants who received Pertagen® and Boostagen® in the initial TDA202 study will be administered a single intramuscular injection of a second booster dose of Pertagen®. The participants who have received Adacel® in the initial TDA202 study will be given a single intramuscular injection of a second booster dose of Adacel® (Table 1). Composition of booster vaccines are presented in Table 2. The vaccine preparation and administration will be performed by appropriately trained study team and study nurses, respectively, who are delegated by the Principal Investigator.
If a participant does not complete screening visit and Visit 1 (Day 0) on the same day, the screening process for general health status (medical history, medication history, immunization history, history of receiving blood, blood component, immunoglobulin, immunosuppressive drugs or systemic corticosteroid, vital signs and physical examination), urine pregnancy test for female participants with childbearing potential and inclusion and exclusion criteria will be assessed again at Visit 1.
Brief description of the study design for TDA202 10-year follow-up study:
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) conducted from July 2015 to November 2016. Only those who were enrolled in the initial TDA202 study and had completed TDA202 1-year follow-up will be recruited for this 10-year follow-up study.
Participants from all 3 vaccine groups (i.e., participants who had received a single dose of one of the 3 study vaccines (Boostagen®, Pertagen®, or Adacel®) and completed 1-year follow-up visit at Day 336±28 days during the TDA202 study will be called in for informed consent process at Visit 0 (Screening) at approximately 10 years (range, 9.5-10 years) following vaccination.
At Visit 0, Screening visit, participants who have signed the written Informed Consent Forms will be screened for general health status (medical history, medication history, immunization history, history of receiving blood, blood component, immunoglobulin, immunosuppressive drugs or systemic corticosteroid, vital signs and physical examination) and those who fulfill the pre-defined inclusion criteria without meeting any exclusion criteria will be enrolled into the study. The screening visit and Visit 1 (Day 0) can be completed on the same day. Once enrolled, a blood sample (approx. 5 mL) will be taken from all participants at Visit 1 (before second booster vaccination) and at Visit 2 (28 days after second booster vaccination) as shown in the diagram below (Figure 1).
At Visit 1, Day 0 (enrollment and second booster vaccination), a blood sample (approx. 5 mL) will be taken from all enrolled participants. After blood collection, the participants who received Pertagen® and Boostagen® in the initial TDA202 study will be administered a single intramuscular injection of a second booster dose of Pertagen®. The participants who have received Adacel® in the initial TDA202 study will be given a single intramuscular injection of a second booster dose of Adacel® (Table 1). Composition of booster vaccines are presented in Table 2. The vaccine preparation and administration will be performed by appropriately trained study team and study nurses, respectively, who are delegated by the Principal Investigator.
If a participant does not complete screening visit and Visit 1 (Day 0) on the same day, the screening process for general health status (medical history, medication history, immunization history, history of receiving blood, blood component, immunoglobulin, immunosuppressive drugs or systemic corticosteroid, vital signs and physical examination), urine pregnancy test for female participants with childbearing potential and inclusion and exclusion criteria will be assessed again at Visit 1.
Table 1: Vaccine groups and booster dose vaccination Vaccine group in Initial TDA202 study Second booster vaccination at Day 0 Total number of participants (N) per vaccine group Pertagen® and Boostagen® Pertagen® 84 Adacel® Adacel® 42 After the second booster vaccination, participants will be observed at the study site for at least 30 minutes to monitor for any immediate post-immunization reactions. Safety and reactogenicity in the participants will be assessed until end of study. The diary cards will be distributed to the participants to record post-immunization solicited local and systemic adverse events (AEs) until Day 7 and unsolicited AEs, serious adverse events (SAEs), and concomitant medications until Day 28 following vaccination. The study staff will contact the participants by phone on Day 7 (+4 days) to enquire on health status and to remind them to record any solicited local and systemic AEs, unsolicited AE, SAE and concomitant medications in the diary card.
At Visit 2, Day 28 (+7 days), participants will return to the study site for blood sample collection (approx. 5 mL), reconciliation of information in the diary card, and any reported AEs, SAEs and concomitant medications.
Safety and reactogenicity will be assessed until end of study. Solicited local and systemic AEs will be collected until Day 7 after the second booster vaccination. Unsolicited Adverse Events (AEs) and Serious Adverse Events (SAEs) will be collected until Visit 2 (Day 28) after the second booster vaccination. Visit 2 is considered the end of study.
Blood samples collected from all participants at Day 0 (Visit 1) and Day 28 (Visit 2) will be processed for serum preparation. Serum samples will be stored at the laboratory at the study site and will be further shipped to BioNet-Asia Human Serology Laboratory where immunogenicity testing will be performed. At Day 0 (Visit 1) and Day 28 (Visit 2), ELISA testing to detect antibodies against pertussis toxoid (PT), filamentous hemagglutinin (FHA) and PT neutralizing assay in Chinese Hamster Ovary (CHO) cells will be performed for all enrolled participants. At Day 0 (Visit 1), ELISA testing to detect antibodies against tetanus toxoid (TT) and diphtheria toxoid (DT) will be performed for participants who received Boostagen® and Adacel® in TDA202 initial study.
Data management and statistical analysis will be performed by the Center of Excellence for Biomedical and Public Health Informatics (BIOPHICS), Bangkok, Thailand.
- Conditions
- Pertussis
- Being tested
- Pertagen® vaccine, Adacel® vaccine
- Keywords
- TDA202, acellular pertussis vaccine, a second booster dose of Pertagen® as compared to Adacel®, antibody persistence at 10 years after vaccination, Pertagen, Boostagen, aP vaccine
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pertagen® vaccineBiological
Pertagen® vaccine, manufactured by BioNet-Asia Co., Ltd., Bangkok, Thailand. The vaccine is presented in pre-filled syringe, each containing one human dose (0.5 mL) of aP vaccine.
Adacel® vaccineBiological
Adacel® vaccine, manufactured by Sanofi Pasteur, Ltd, Toronto, Ontario, Canada. The vaccine is presented in a single-dose vial, each containing one human dose (0.5 mL) of Tdap vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Pertagen® vaccine | Experimental | Pertagen® vaccine, manufactured by BioNet-Asia Co., Ltd., Bangkok, Thailand. The vaccine is presented in pre-filled syringe, each containing one human dose (0.5 mL) of aP vaccine. Receives: Biological: Pertagen® vaccine |
| Adacel® vaccine | Experimental | Adacel® vaccine, manufactured by Sanofi Pasteur, Ltd, Toronto, Ontario, Canada. The vaccine is presented in a single-dose vial, each containing one human dose (0.5 mL) of Tdap vaccine. Receives: Biological: Adacel® vaccine |
| Boostagen® vaccine | Experimental | BIoNet Recombinant TdaP, each 0.5 mL dose of Boostagen (TdaP BioNet) contained 5 μg PTgen, 5 μg FHA, and 0.3 mg as aluminium cation. Receives: Biological: Pertagen® vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate superiority at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.
Geometric mean concentration (GMC) of anti-PT and anti-FHA antibodies measured at baseline (before second booster vaccination) and 28 days following vaccination.
Measured: Day 28
Secondary outcomes (14)
Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.
- GMC of PT neutralizing antibody (PTNA) measured at baseline (before second booster vaccination) and 28 days following vaccination.
Measured: Day 28
Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.
- Seroconversion rates as defined by proportion of participants with antibody concentrations ≥ 4-fold increase with respect to baseline (before first and second booster vaccination) of anti-PT and anti-FHA, and PT- neutralizing antibodies at 28 days after booster dose vaccination.
Measured: Day 28
Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.
- Seropositive rates as defined by proportion of participants with antibody concentrations > 5 IU/mL for anti-PT and anti-FHA, and PT-neutralizing antibodies at baseline (before first and second booster vaccination) and 28 days after booster dose vaccination.
Measured: Day 28
Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.
- Booster response rates as defined by proportion of participants with antibody concentrations >20 IU/mL for anti-PT and anti-FHA, and PT-neutralizing antibodies at baseline (before first and second booster vaccination) and 28 days after booster dose vaccination.
Measured: Day 28
Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.
- The proportion of participants with cut-off levels of anti-PT, anti-FHA and PT-neutralizing antibodies (i.e, ≥ 5, > 5, ≥ 10, ≥ 20, ≥ 30, ≥ 40, ≥ 50, ≥ 80, ≥ 100, ≥ 120 IU/mL) in Pertagen® and Adacel® at baseline (before first and second booster vaccination) and 28 days after booster dose vaccination.
Measured: Day 28
Immunogenicity endpoints for antibody response before second booster vaccination at 10 years after a single dose vaccination of Boostagen® and Pertagen® as compared to Adacel® from initial TDA202 study
- GMCs of anti-PT, anti-FHA and PT-neutralizing antibodies in all vaccine groups and GMCs of anti-TT and anti-DT antibodies in Boostagen® and Adacel® at 10 years after vaccination
Measured: 10 years safter vaccination
Immunogenicity endpoints for antibody response before second booster vaccination at 10 years after a single dose vaccination of Boostagen® and Pertagen® as compared to Adacel® from initial TDA202 study
- Seropositive rates as defined by proportion of participants with antibody concentrations >5 IU/mL for anti-PT and anti-FHA, and PT-neutralizing antibodies at 10 years after vaccination
Measured: 10 years safter vaccination
Immunogenicity endpoints for antibody response before second booster vaccination at 10 years after a single dose vaccination of Boostagen® and Pertagen® as compared to Adacel® from initial TDA202 study
- Booster response rates as defined by proportion of participants with antibody concentrations >20 IU/mL for anti-PT and anti-FHA, and PT neutralizing antibodies at 10 years after vaccination
Measured: 10 years safter vaccination
Immunogenicity endpoints for antibody response before second booster vaccination at 10 years after a single dose vaccination of Boostagen® and Pertagen® as compared to Adacel® from initial TDA202 study
- Seroconversion rates as defined by proportion of participants with antibody concentrations ≥ 2-fold increase with respect to baseline of anti-PT and anti-FHA, and PT-neutralizing antibodies at 10 years after vaccination
Measured: 10 years safter vaccination
Immunogenicity endpoints for antibody response before second booster vaccination at 10 years after a single dose vaccination of Boostagen® and Pertagen® as compared to Adacel® from initial TDA202 study
- Seroconversion rates as defined by proportion of participants with antibody concentrations ≥ 4-fold increase with respect to baseline, of anti-PT and anti-FHA, and PT-neutralizing antibodies at 10 years after vaccination
Measured: 10 years safter vaccination
Immunogenicity endpoints for antibody response before second booster vaccination at 10 years after a single dose vaccination of Boostagen® and Pertagen® as compared to Adacel® from initial TDA202 study
- Seroprotection rate as defined by proportion of participants with antibody concentrations > 0.1 IU/mL of anti-TT and anti-DT antibodies in Boostagen® and Adacel® vaccine groups at 10 years after vaccination. The proportion of participants with cut-off levels of anti-PT, anti-FHA and PT-neutralizing antibodies (i.e, ≥ 5, > 5, ≥ 10, ≥ 20, ≥ 30, ≥ 40, ≥ 50, ≥ 80, ≥ 100, ≥ 120 IU/mL) in Pertagen®, Boostagen® and Adacel® at 10 years after vaccination
Measured: 10 years safter vaccination
Safety endpoints at 28 days post-booster vaccination with one dose of Pertagen® and Adacel®
- Percentage of participants with solicited local and systemic AEs reported within 7 days after booster vaccination
Measured: From Day 0 to Day 7
Safety endpoints at 28 days post-booster vaccination with one dose of Pertagen® and Adacel®
- Percentage of participants with unsolicited AEs reported from the day of booster vaccination through 28 days following booster vaccination
Measured: From Day 0 to Day 28
Safety endpoints at 28 days post-booster vaccination with one dose of Pertagen® and Adacel®
- Percentage of participants with SAEs reported from the day of booster vaccination through 28 days following booster vaccination
Measured: From Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start13 May 2025
- Primary completion24 Jun 2025
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PertussisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- BioNet-Asia Co., Ltd.
- Responsible party
- Principal investigator, Punnee Pitisuttithum, Mahidol University
- Investigators
- Punnee Pitisuttithum, Principal investigator, Vaccine trial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803524
- Sponsor's protocol ID
- TDA 202 10-year follow-up
- Status last verified
- Oct 2026
- First submitted
- 27 Jan 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibody Persistence and Safety and Immunogenicity of a Second Booster Dose 10 Years After a First Booster Vaccination With a Single Dose Vaccination of aP Vaccine in Adults: A Phase IV, Open-label, Non-randomized, Follow-up Study
- ClinicalTrials.gov ID
- NCT06803524
- Acronym / sponsor ID
- TDA 202 10-year follow-up
- Conditions
- Pertussis
- Keywords
- TDA202, acellular pertussis vaccine, a second booster dose of Pertagen® as compared to Adacel®, antibody persistence at 10 years after vaccination, Pertagen, Boostagen, aP vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- BioNet-Asia Co., Ltd.
- Study start
- 13 May 2025 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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) conducted from July 2015 to November 2016. Only those who were enrolled in the initial TDA202 study and had completed TDA202 1-year follow-up will be recruited for this 10-year follow-up study.
Participants from all 3 vaccine groups (i.e., participants who had received a single dose of one of the 3 study vaccines (Boostagen®, Pertagen®, or Adacel®) and completed 1-year follow-up visit at Day 336±28 days during the TDA202 study will be called in for informed consent process at Visit 0 (Screening) at approximately 10 years (range, 9.5-10 years) following vaccination.
At Visit 0, Screening visit, participants who have signed the written Informed Consent Forms will be screened for general health status (medical history, medication history, immunization history, history of receiving blood, blood component, immunoglobulin, immunosuppressive drugs or systemic corticosteroid, vital signs and physical examination) and those who fulfill the pre-defined inclusion criteria without meeting any exclusion criteria will be enrolled into the study. The screening visit and Visit 1 (Day 0) can be completed on the same day. Once enrolled, a blood sample (approx. 5 mL) will be taken from all participants at Visit 1 (before second booster vaccination) and at Visit 2 (28 days after second booster vaccination) as shown in the diagram below (Figure 1).
At Visit 1, Day 0 (enrollment and second booster vaccination), a blood sample (approx. 5 mL) will be taken from all enrolled participants. After blood collection, the participants who received Pertagen® and Boostagen® in the initial TDA202 study will be administered a single intramuscular injection of a second booster dose of Pertagen®. The participants who have received Adacel® in the initial TDA202 study will be given a single intramuscular injection of a second booster dose of Adacel® (Table 1). Composition of booster vaccines are presented in Table 2. The vaccine preparation and administration will be performed by appropriately trained study team and study nurses, respectively, who are delegated by the Principal Investigator.
If a participant does not complete screening visit and Visit 1 (Day 0) on the same day, the screening process for general health status (medical history, medication history, immunization history, history of receiving blood, blood component, immunoglobulin, immunosuppressive drugs or systemic corticosteroid, vital signs and physical examination), urine pregnancy test for female participants with childbearing potential and inclusion and exclusion criteria will be assessed again at Visit 1.
Brief description of the study design for TDA202 10-year follow-up study:
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) conducted from July 2015 to November 2016. Only those who were enrolled in the initial TDA202 study and had completed TDA202 1-year follow-up will be recruited for this 10-year follow-up study.
Participants from all 3 vaccine groups (i.e., participants who had received a single dose of one of the 3 study vaccines (Boostagen®, Pertagen®, or Adacel®) and completed 1-year follow-up visit at Day 336±28 days during the TDA202 study will be called in for informed consent process at Visit 0 (Screening) at approximately 10 years (range, 9.5-10 years) following vaccination.
At Visit 0, Screening visit, participants who have signed the written Informed Consent Forms will be screened for general health status (medical history, medication history, immunization history, history of receiving blood, blood component, immunoglobulin, immunosuppressive drugs or systemic corticosteroid, vital signs and physical examination) and those who fulfill the pre-defined inclusion criteria without meeting any exclusion criteria will be enrolled into the study. The screening visit and Visit 1 (Day 0) can be completed on the same day. Once enrolled, a blood sample (approx. 5 mL) will be taken from all participants at Visit 1 (before second booster vaccination) and at Visit 2 (28 days after second booster vaccination) as shown in the diagram below (Figure 1).
At Visit 1, Day 0 (enrollment and second booster vaccination), a blood sample (approx. 5 mL) will be taken from all enrolled participants. After blood collection, the participants who received Pertagen® and Boostagen® in the initial TDA202 study will be administered a single intramuscular injection of a second booster dose of Pertagen®. The participants who have received Adacel® in the initial TDA202 study will be given a single intramuscular injection of a second booster dose of Adacel® (Table 1). Composition of booster vaccines are presented in Table 2. The vaccine preparation and administration will be performed by appropriately trained study team and study nurses, respectively, who are delegated by the Principal Investigator.
If a participant does not complete screening visit and Visit 1 (Day 0) on the same day, the screening process for general health status (medical history, medication history, immunization history, history of receiving blood, blood component, immunoglobulin, immunosuppressive drugs or systemic corticosteroid, vital signs and physical examination), urine pregnancy test for female participants with childbearing potential and inclusion and exclusion criteria will be assessed again at Visit 1.
Table 1: Vaccine groups and booster dose vaccination Vaccine group in Initial TDA202 study Second booster vaccination at Day 0 Total number of participants (N) per vaccine group Pertagen® and Boostagen® Pertagen® 84 Adacel® Adacel® 42 After the second booster vaccination, participants will be observed at the study site for at least 30 minutes to monitor for any immediate post-immunization reactions. Safety and reactogenicity in the participants will be assessed until end of study. The diary cards will be distributed to the participants to record post-immunization solicited local and systemic adverse events (AEs) until Day 7 and unsolicited AEs, serious adverse events (SAEs), and concomitant medications until Day 28 following vaccination. The study staff will contact the participants by phone on Day 7 (+4 days) to enquire on health status and to remind them to record any solicited local and systemic AEs, unsolicited AE, SAE and concomitant medications in the diary card.
At Visit 2, Day 28 (+7 days), participants will return to the study site for blood sample collection (approx. 5 mL), reconciliation of information in the diary card, and any reported AEs, SAEs and concomitant medications.
Safety and reactogenicity will be assessed until end of study. Solicited local and systemic AEs will be collected until Day 7 after the second booster vaccination. Unsolicited Adverse Events (AEs) and Serious Adverse Events (SAEs) will be collected until Visit 2 (Day 28) after the second booster vaccination. Visit 2 is considered the end of study.
Blood samples collected from all participants at Day 0 (Visit 1) and Day 28 (Visit 2) will be processed for serum preparation. Serum samples will be stored at the laboratory at the study site and will be further shipped to BioNet-Asia Human Serology Laboratory where immunogenicity testing will be performed. At Day 0 (Visit 1) and Day 28 (Visit 2), ELISA testing to detect antibodies against pertussis toxoid (PT), filamentous hemagglutinin (FHA) and PT neutralizing assay in Chinese Hamster Ovary (CHO) cells will be performed for all enrolled participants. At Day 0 (Visit 1), ELISA testing to detect antibodies against tetanus toxoid (TT) and diphtheria toxoid (DT) will be performed for participants who received Boostagen® and Adacel® in TDA202 initial study.
Data management and statistical analysis will be performed by the Center of Excellence for Biomedical and Public Health Informatics (BIOPHICS), Bangkok, Thailand.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pertagen® vaccine | Experimental | Biological: Pertagen® vaccinePertagen® vaccine, manufactured by BioNet-Asia Co., Ltd., Bangkok, Thailand. The vaccine is presented in pre-filled syringe, each containing one human dose (0.5 mL) of aP vaccine. |
| Adacel® vaccine | Experimental | Biological: Adacel® vaccineAdacel® vaccine, manufactured by Sanofi Pasteur, Ltd, Toronto, Ontario, Canada. The vaccine is presented in a single-dose vial, each containing one human dose (0.5 mL) of Tdap vaccine. |
| Boostagen® vaccine | Experimental | Biological: Pertagen® vaccineBIoNet Recombinant TdaP, each 0.5 mL dose of Boostagen (TdaP BioNet) contained 5 μg PTgen, 5 μg FHA, and 0.3 mg as aluminium cation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (16 listed)
- 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 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pertagen® vaccinePertagen® vaccine, manufactured by BioNet-Asia Co., Ltd., Bangkok, Thailand. The vaccine is presented in pre-filled syringe, each containing one human dose (0.5 mL) of aP vaccine. | Biological | Boostagen® vaccine, Pertagen® vaccine |
| Adacel® vaccineAdacel® vaccine, manufactured by Sanofi Pasteur, Ltd, Toronto, Ontario, Canada. The vaccine is presented in a single-dose vial, each containing one human dose (0.5 mL) of Tdap vaccine. | Biological | Adacel® vaccine |
Primary outcome
To demonstrate superiority at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.
Time frame: Day 28
Geometric mean concentration (GMC) of anti-PT and anti-FHA antibodies measured at baseline (before second booster vaccination) and 28 days following vaccination.
14 secondary outcomes
Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.
Time frame: Day 28
Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.
Time frame: Day 28
Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.
Time frame: Day 28
Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.
Time frame: Day 28
Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.
Time frame: Day 28
Immunogenicity endpoints for antibody response before second booster vaccination at 10 years after a single dose vaccination of Boostagen® and Pertagen® as compared to Adacel® from initial TDA202 study
Time frame: 10 years safter vaccination
Immunogenicity endpoints for antibody response before second booster vaccination at 10 years after a single dose vaccination of Boostagen® and Pertagen® as compared to Adacel® from initial TDA202 study
Time frame: 10 years safter vaccination
Immunogenicity endpoints for antibody response before second booster vaccination at 10 years after a single dose vaccination of Boostagen® and Pertagen® as compared to Adacel® from initial TDA202 study
Time frame: 10 years safter vaccination
Immunogenicity endpoints for antibody response before second booster vaccination at 10 years after a single dose vaccination of Boostagen® and Pertagen® as compared to Adacel® from initial TDA202 study
Time frame: 10 years safter vaccination
Immunogenicity endpoints for antibody response before second booster vaccination at 10 years after a single dose vaccination of Boostagen® and Pertagen® as compared to Adacel® from initial TDA202 study
Time frame: 10 years safter vaccination
Immunogenicity endpoints for antibody response before second booster vaccination at 10 years after a single dose vaccination of Boostagen® and Pertagen® as compared to Adacel® from initial TDA202 study
Time frame: 10 years safter vaccination
Safety endpoints at 28 days post-booster vaccination with one dose of Pertagen® and Adacel®
Time frame: From Day 0 to Day 7
Safety endpoints at 28 days post-booster vaccination with one dose of Pertagen® and Adacel®
Time frame: From Day 0 to Day 28
Safety endpoints at 28 days post-booster vaccination with one dose of Pertagen® and Adacel®
Time frame: From Day 0 to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Punnee Pitisuttithum principal investigator
Vaccine trial Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pertagen® vaccine and Adacel® vaccine in people with Pertussis, run by Mahidol University at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate superiority at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®. (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.