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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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:

  1. 15 to 36 months of age at the time of vaccination.
  2. Having completed the 3-dose DTwP or 3-dose DTaP vaccination (no interchange of DTwP and DTaP during primary immunization).
  3. The parents or legal guardians of the participant are able to read and write.
  4. The parents or legal guardians can provide written informed consent.
  5. 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

  1. 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.
  2. History of allergy or hypersensitivity to any vaccine (including its component).
  3. History of any serious adverse event or neurological adverse event after vaccination.
  4. Having received only 1 or 2 doses of DTwP or DTaP (incomplete primary immunization) after birth until the study enrollment.
  5. Having received the 4th dose DTwP or DTaP vaccination.
  6. Having experienced a physician diagnosed diphtheria or tetanus or pertussis illness within 1 year prior to recruitment.
  7. Receipt of any vaccine within 28 days prior to enrollment (3 months for live-attenuated vaccines).
  8. Planning to receive tetanus, diphtheria, pertussis or planning to participate in another clinical trial during the study period (approximately 1 year).
  9. Receipt of blood or blood component or immunoglobulin within 3 months prior to recruitment.
  10. 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.
  11. Any bleeding disorder.
  12. Any abnormality of splenic or thymic function.
  13. Any progressive or severe neurological disorder such as seizure disorder or Guillain- Barre syndrome;
  14. 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.
  15. 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

Other trials in Thailand

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.

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 groups in NCT07213089
Study groupRoleWhat they receive
Combined Diphtheria-Tetanus-recombinant acellular pertussis (DTaP) vaccineExperimentalParticipants 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 DTaPActive comparatorParticipants 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.

  1. Seroconversion rates of PT

    ELISA

    Measured: At 28 days following vaccination

Secondary outcomes (12)
  1. 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

  2. Percentages of participants with AEs

    AEs reported by participant

    Measured: During 28 days following vaccination

  3. Percentages of participants with SAEs

    SAEs reported by participant

    Measured: During 28 days following vaccination

  4. GMT antibody concentration to anti-PT neutralizing antibody

    CHO

    Measured: Baseline and Day 28 after vaccination

  5. GMT antibody concentration to DT, TT, PT and FHA

    ELISA

    Measured: Baseline and Day 28 after vaccination

  6. Seroprotection rates of Tetanus and Diphtheria

    ELISA

    Measured: Day 28 after vaccination

  7. Seroconversion rates of FHA and anti-PT neutralizing antibody

    ELISA and CHO

    Measured: Day 28 after vaccination

  8. Percentages of participants with SAEs

    SAEs reported by participant

    Measured: Day 336 after vaccination

  9. Seroconversion rates of FHA and anti-PT neutralizing antibody

    ELISA and CHO

    Measured: Day 336 after vaccination

  10. GMT antibody concentration to DT, TT, PT and FHA

    ELISA

    Measured: Day 336 after vaccination

  11. GMT antibody concentration to anti-PT neutralizing antibody

    CHO

    Measured: Day 336 after vaccination

  12. 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.

  1. First posted8 Oct 2025
  2. Study start13 Jul 2020
  3. Primary completion4 Apr 2022
  4. Study completion12 May 2022

Resources

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)
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

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.

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