Immunogenicity of a Combined Diphtheria-Tetanus-recombinant Acellular Pertussis (DTaP) Vaccine in Healthy Toddlers

NCT07213089 | Completed Phase 2

• 2 other identifiers: DTA201TCTR20200325002
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Pertussis Whooping Cough

Keywords

Pertussis Whooping cough

Outcome Measures

Primary Outcomes (1)

• Seroconversion rates of PT

  ELISA

  At 28 days following vaccination

Secondary Outcomes (12)

• Percentages of participants with solicited post-immunization local and systemic reactions

  During 7 days following vaccination

• Percentages of participants with AEs

  During 28 days following vaccination

• Percentages of participants with SAEs

  During 28 days following vaccination

• GMT antibody concentration to anti-PT neutralizing antibody

  Baseline and Day 28 after vaccination

• GMT antibody concentration to DT, TT, PT and FHA

  Baseline and Day 28 after vaccination

Study Arms (2)

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

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

Biological: Licensed DTaP

Interventions

Combined Diphtheria-Tetanus-recombinant acellular pertussis (DTaP) vaccine BIOLOGICAL

A single dose of Acellular pertussis (DTaP) vaccine 0.5 ml will be given by intramuscularly at Day 0

Combined Diphtheria-Tetanus-recombinant acellular pertussis (DTaP) vaccine

Licensed DTaP BIOLOGICAL

A single dose of Acellular pertussis (DTaP) vaccine 0.5 ml. will be given by intramuscular as at Day 0

Licensed DTaP

Eligibility Criteria

• Age: 15 Years - 36 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioNet-Asia Co., Ltd.: lead
• National Science and Technology Development Agency, Thailand: collaborator
• Mahidol University: collaborator

Study Sites (3)

Vaccine Trial Centre (VTC), Faculty of Tropical Medicine, Mahidol University

Bangkok, Bangkok, 10400, Thailand

Location

Kamphaengphet Hospital

Kamphaeng Phet, Changwat Kamphaeng Phet, 62000, Thailand

Location

Phaholpolpayuhasena Hospital

Kanchanaburi, Kanchanaburi, 71000, Thailand

Location

MeSH Terms

Interventions

Vaccines

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Prof. Punnee Pitisuttithum

  Vaccine Trial Centre (VTC), Faculty of Tropical Medicine, Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: July 13, 2020
• Primary Completion: April 4, 2022
• Study Completion: May 12, 2022
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (3)