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

NCT07213089 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2025-10-08

No results posted yet for this study

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

Interventions

BIOLOGICAL

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

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

BIOLOGICAL

Licensed DTaP

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

Sponsors & Collaborators

  • National Science and Technology Development Agency, Thailand

    collaborator OTHER_GOV

  • Mahidol University

    collaborator OTHER

  • BioNet-Asia Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Prof. Punnee Pitisuttithum · Vaccine Trial Centre (VTC), Faculty of Tropical Medicine, Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
36 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2022-04-04
Completion
2022-05-12

Countries

  • Thailand

Study Locations

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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 NCT07213089 on ClinicalTrials.gov