Pertussis Whooping CoughPhase 2/3NCT07213089
Immunogenicity of a Combined Diphtheria-Tetanus-recombinant Acellular Pertussis (DTaP) Vaccine in Healthy Toddlers
A Phase 2/3 study testing Combined Diphtheria-Tetanus-recombinant acellular pertussis (DTaP) vaccine and Licensed DTaP in people with Pertussis Whooping Cough, run by BioNet-Asia Co., Ltd. at 3 sites in Thailand.
Trial summary
Recombinant acellular pertussis vaccines containing genetically detoxified Pertussis Toxin (PTgen) have been used for booster immunisation in children, adolescents and adults including pregnant women in Thailand. Read more about this study
- Who is it for?
- Ages 15 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Pertussis Whooping Cough
- What is being tested?
- Combined Diphtheria-Tetanus-recombinant acellular pertussis (DTaP) vaccine and Licensed DTaP
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 3 sitesThailand
- Study dates
- 13 Jul 2020to 12 May 2022
- Phase
- Phase 2/3
- 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 15 to 36 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Inclusion Criteria: Participants will be eligible for inclusion if ALL of the following criteria are met at the time of screening:
- 15 to 36 months of age at the time of vaccination.
- Having completed the 3-dose DTwP or 3-dose DTaP vaccination (no interchange of DTwP and DTaP during primary immunization).
- The parents or legal guardians of the participant are able to read and write.
- The parents or legal guardians can provide written informed consent.
- Healthy, as established by pertinent medical history and physical examination.
Exclusion Criteria: A participant with ANY of the following criteria at study entry will not be eligible for participation
- History of any significant medical illness such as, but not limited to, immune deficiency, renal, hepatic, cardiovascular, or endocrine disorder as determined by the investigator based on medical history and physical examination.
- History of allergy or hypersensitivity to any vaccine (including its component).
- History of any serious adverse event or neurological adverse event after vaccination.
- Having received only 1 or 2 doses of DTwP or DTaP (incomplete primary immunization) after birth until the study enrollment.
- Having received the 4th dose DTwP or DTaP vaccination.
- Having experienced a physician diagnosed diphtheria or tetanus or pertussis illness within 1 year prior to recruitment.
- Receipt of any vaccine within 28 days prior to enrollment (3 months for live-attenuated vaccines).
- Planning to receive tetanus, diphtheria, pertussis or planning to participate in another clinical trial during the study period (approximately 1 year).
- Receipt of blood or blood component or immunoglobulin within 3 months prior to recruitment.
- History of receiving any immunosuppressive drug or systemic corticosteroid (more than 0.5 mg/kg of prednisolone or equivalent for more than 14 days) within 3 months prior to recruitment.
- Any bleeding disorder.
- Any abnormality of splenic or thymic function.
- Any progressive or severe neurological disorder such as seizure disorder or Guillain- Barre syndrome;
- History of any illness including cognitive impairment and psychiatric disease that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the participants due to participation in the study.
- Fever as defined by body temperature more than 38 degree celsius at the time of enrollment (temporary exclusion criterion).
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Vaccine Trial Centre (VTC), Faculty of Tropical Medicine, Mahidol University
Bangkok, Bangkok, 10400
Kamphaengphet Hospital
Kamphaeng Phet, Changwat Kamphaeng Phet, 62000
Phaholpolpayuhasena Hospital
Kanchanaburi, Kanchanaburi, 71000
About this study
Official title: A Phase II/III Randomized, Observer-blind, Active-controlled Study to Compare Non-inferior Immunogenicity of a DTaPgen Vaccine to a Licensed DTaP-IPV, When Administered to Healthy Toddlers Aged of 15-36 Months Old.
Recombinant acellular pertussis vaccines containing genetically detoxified Pertussis Toxin (PTgen) have been used for booster immunisation in children, adolescents and adults including pregnant women in Thailand. Three vaccines have been licensed in Thailand, a monovalent (aPgen) and two vaccines combined with tetanus and reduced diphtheria dose vaccines (TdaPgen and Tdapgen). To address the need for improved vaccines in younger children, a new recombinant pediatric DTaP vaccine (DTaPgen) containing 5 µg genetically detoxified Pertussis Toxin (PTgen) and 10 µg Filamentous Hemagglutinin (FHA) was developed and found safe and immunogenic in a phase II trial in children aged 3 years onwards.
The purpose of this study is to assess the immunogenicity and safety of this new pediatric formulation DTaPgen given as the first booster dose in healthy toddlers aged 15 to 36 months compared to a commercially available vaccine in Thailand.
Read the detailed description
This is a phase II/III randomized, observer-blind, active-controlled study conducted in Thailand, children aged 15-36-month-old with a history of DTwP (n=240) or DTaP (n=50) priming were randomized 2:1 to receive a dose of recombinant DTaPgen or licensed DTaP-IPV. The aim of this study is to evaluate the safety and non-inferior immunogenicity of DTaPgen versus DTaP-IPV vaccine given as the first booster dose in toddlers.
Safety up to 1-year and vaccine antibody persistence will also be assessed for all children.
- Conditions
- Pertussis Whooping Cough
- Being tested
- Combined Diphtheria-Tetanus-recombinant acellular pertussis (DTaP) vaccine, Licensed DTaP
- Keywords
- Pertussis Whooping cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Diphtheria-Tetanus-recombinant acellular pertussis (DTaP) vaccineBiological
A single dose of Acellular pertussis (DTaP) vaccine 0.5 ml will be given by intramuscularly at Day 0
Licensed DTaPBiological
A single dose of Acellular pertussis (DTaP) vaccine 0.5 ml. will be given by intramuscular as at Day 0
| Study group | Role | What they receive |
|---|---|---|
| Combined Diphtheria-Tetanus-recombinant acellular pertussis (DTaP) vaccine | Experimental | Participants who having completed the 3 doses DTwP or 3-dose DTaP vaccination (on interchange of DTwP and DTaP during primary immunization) will be randomized to receive Acellular pertussis (DTaP) vaccine (0.5 ml) given by intramuscularly as a single dose Receives: Biological: Combined Diphtheria-Tetanus-recombinant acellular pertussis (DTaP) vaccine |
| Licensed DTaP | Active comparator | Participants who having completed the 3 doses DTwP or 3-dose DTaP vaccination (on interchange of DTwP and DTaP during primary immunization) will be randomized to receive Acellular pertussis (DTaP) vaccine (0.5 ml) given by intramuscularly as a single dose Receives: Biological: Licensed DTaP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rates of PT
ELISA
Measured: At 28 days following vaccination
Secondary outcomes (12)
Percentages of participants with solicited post-immunization local and systemic reactions
Self assessment by participant and data record from Diary Card
Measured: During 7 days following vaccination
Percentages of participants with AEs
AEs reported by participant
Measured: During 28 days following vaccination
Percentages of participants with SAEs
SAEs reported by participant
Measured: During 28 days following vaccination
GMT antibody concentration to anti-PT neutralizing antibody
CHO
Measured: Baseline and Day 28 after vaccination
GMT antibody concentration to DT, TT, PT and FHA
ELISA
Measured: Baseline and Day 28 after vaccination
Seroprotection rates of Tetanus and Diphtheria
ELISA
Measured: Day 28 after vaccination
Seroconversion rates of FHA and anti-PT neutralizing antibody
ELISA and CHO
Measured: Day 28 after vaccination
Percentages of participants with SAEs
SAEs reported by participant
Measured: Day 336 after vaccination
Seroconversion rates of FHA and anti-PT neutralizing antibody
ELISA and CHO
Measured: Day 336 after vaccination
GMT antibody concentration to DT, TT, PT and FHA
ELISA
Measured: Day 336 after vaccination
GMT antibody concentration to anti-PT neutralizing antibody
CHO
Measured: Day 336 after vaccination
Seroprotection rates of Tetanus and Diphtheria
ELISA
Measured: Day 336 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start13 Jul 2020
- Primary completion4 Apr 2022
- Study completion12 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pertussis Whooping CoughStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioNet-Asia Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Science and Technology Development Agency, Thailand, Mahidol University
- Responsible party
- Sponsor
- Investigators
- Prof. Punnee Pitisuttithum, Principal investigator, Vaccine Trial Centre (VTC), Faculty of Tropical Medicine, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213089
- Sponsor's protocol ID
- DTA201
- Other IDs
- TCTR20200325002
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Randomized, Observer-blind, Active-controlled Study to Compare Non-inferior Immunogenicity of a DTaPgen Vaccine to a Licensed DTaP-IPV, When Administered to Healthy Toddlers Aged of 15-36 Months Old.
- ClinicalTrials.gov ID
- NCT07213089
- Acronym / sponsor ID
- DTA201
- Conditions
- Pertussis Whooping Cough
- Keywords
- Pertussis Whooping cough
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- BioNet-Asia Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- National Science and Technology Development Agency, Thailand, Mahidol University
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 8 Oct 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.
Recombinant acellular pertussis vaccines containing genetically detoxified Pertussis Toxin (PTgen) have been used for booster immunisation in children, adolescents and adults including pregnant women in Thailand. Three vaccines have been licensed in Thailand, a monovalent (aPgen) and two vaccines combined with tetanus and reduced diphtheria dose vaccines (TdaPgen and Tdapgen). To address the need for improved vaccines in younger children, a new recombinant pediatric DTaP vaccine (DTaPgen) containing 5 µg genetically detoxified Pertussis Toxin (PTgen) and 10 µg Filamentous Hemagglutinin (FHA) was developed and found safe and immunogenic in a phase II trial in children aged 3 years onwards.
The purpose of this study is to assess the immunogenicity and safety of this new pediatric formulation DTaPgen given as the first booster dose in healthy toddlers aged 15 to 36 months compared to a commercially available vaccine in Thailand.
Detailed description
This is a phase II/III randomized, observer-blind, active-controlled study conducted in Thailand, children aged 15-36-month-old with a history of DTwP (n=240) or DTaP (n=50) priming were randomized 2:1 to receive a dose of recombinant DTaPgen or licensed DTaP-IPV. The aim of this study is to evaluate the safety and non-inferior immunogenicity of DTaPgen versus DTaP-IPV vaccine given as the first booster dose in toddlers.
Safety up to 1-year and vaccine antibody persistence will also be assessed for all children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Diphtheria-Tetanus-recombinant acellular pertussis (DTaP) vaccine | Experimental | Biological: Combined Diphtheria-Tetanus-recombinant acellular pertussis (DTaP) vaccineParticipants who having completed the 3 doses DTwP or 3-dose DTaP vaccination (on interchange of DTwP and DTaP during primary immunization) will be randomized to receive Acellular pertussis (DTaP) vaccine (0.5 ml) given by intramuscularly as a single dose |
| Licensed DTaP | Active comparator | Biological: Licensed DTaPParticipants who having completed the 3 doses DTwP or 3-dose DTaP vaccination (on interchange of DTwP and DTaP during primary immunization) will be randomized to receive Acellular pertussis (DTaP) vaccine (0.5 ml) given by intramuscularly as a single dose |
Who may qualify
- Ages
- 15 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Combined Diphtheria-Tetanus-recombinant acellular pertussis (DTaP) vaccineA single dose of Acellular pertussis (DTaP) vaccine 0.5 ml will be given by intramuscularly at Day 0 | Biological | Combined Diphtheria-Tetanus-recombinant acellular pertussis (DTaP) vaccine |
| Licensed DTaPA single dose of Acellular pertussis (DTaP) vaccine 0.5 ml. will be given by intramuscular as at Day 0 | Biological | Licensed DTaP |
Primary outcome
Seroconversion rates of PT
Time frame: At 28 days following vaccination
ELISA
12 secondary outcomes
Percentages of participants with solicited post-immunization local and systemic reactions
Time frame: During 7 days following vaccination
Percentages of participants with AEs
Time frame: During 28 days following vaccination
Percentages of participants with SAEs
Time frame: During 28 days following vaccination
GMT antibody concentration to anti-PT neutralizing antibody
Time frame: Baseline and Day 28 after vaccination
GMT antibody concentration to DT, TT, PT and FHA
Time frame: Baseline and Day 28 after vaccination
Seroprotection rates of Tetanus and Diphtheria
Time frame: Day 28 after vaccination
Seroconversion rates of FHA and anti-PT neutralizing antibody
Time frame: Day 28 after vaccination
Percentages of participants with SAEs
Time frame: Day 336 after vaccination
Seroconversion rates of FHA and anti-PT neutralizing antibody
Time frame: Day 336 after vaccination
GMT antibody concentration to DT, TT, PT and FHA
Time frame: Day 336 after vaccination
GMT antibody concentration to anti-PT neutralizing antibody
Time frame: Day 336 after vaccination
Seroprotection rates of Tetanus and Diphtheria
Time frame: Day 336 after vaccination
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 2025.
- Individual participant dataSharing planned: No. Undecided
Related trials for Pertussis Whooping Cough
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Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
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.
Prof. Punnee Pitisuttithum principal investigator
Vaccine Trial Centre (VTC), Faculty of Tropical Medicine, Mahidol University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Combined Diphtheria-Tetanus-recombinant acellular pertussis (DTaP) vaccine and Licensed DTaP in people with Pertussis Whooping Cough, run by BioNet-Asia Co., Ltd. at 3 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?
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 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Seroconversion rates of PT (time frame: At 28 days following vaccination). 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 2025.