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Maternal Immunization With Tetanus Toxoid, Reduced Diphtheria Toxoid, Reduced-dose (2 µg) Recombinant Pertussis Vaccine (TdaP2gen) and Its Effect on the Immune Response in Thai Infants up to 15-18 Months Old

NCT07621341 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2026-06-02

No results posted yet for this study

Summary

Pertussis remains a major global public health problem. In Thailand, pertussis vaccination is recommended during pregnancy at 20-32 weeks' gestation, together with routine childhood diphtheria-tetanus-pertussis vaccination administered as a primary series at 2, 4, and 6 months and booster doses at 18 months and 4-6 years of age.

TdaP2gen, a newly developed combined tetanus, diphtheria, and recombinant genetically detoxified acellular pertussis vaccine containing 2 µg pertussis antigen, has shown favorable safety and non-inferior immunogenicity compared with existing pertussis vaccines. However, data on its use in pregnant women, transplacental antibody transfer, and potential immune interference in infants remain limited.

This study aims to evaluate the safety and immunogenicity of TdaP2gen in pregnant women, assess antibody transfer to newborns, and investigate immune responses to tetanus, diphtheria, and pertussis following primary and booster pertussis-containing vaccinations in infants and toddlers, including comparisons between whole-cell and acellular pertussis-containing vaccine schedules.

Conditions

  • Pertussis
  • Diphtheria
  • Tetanus
  • Vaccine-Preventable Diseases

Interventions

BIOLOGICAL

Maternal TdaP2gen vaccine

A combined tetanus toxoid, reduced diphtheria toxoid, reduced-dose (2 µg) genetically-detoxified recombinant acellular pertussis vaccine (TdaP2gen)

BIOLOGICAL

Infant Acellular Pertussis-containing Vaccine

An infant acellular pertussis (aP)-containing vaccine

BIOLOGICAL

Infant Whole-cell Pertussis-containing Vaccine

An infant whole-cell pertussis (wP)-containing vaccine

Sponsors & Collaborators

  • Thailand Center of Excellence for Life Sciences

    collaborator UNKNOWN

  • Chiang Mai University

    lead OTHER

Principal Investigators

  • Tavitiya Sudjaritruk, MD, PhD · Department of Pediatrics, Faculty of Medicine, Chiang Mai University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-26
Primary Completion
2029-12-31
Completion
2030-12-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07621341 on ClinicalTrials.gov