NCT07213089

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

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.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: BioNet-Asia Co., Ltd. · Industry
• Sex: All
• Age: 15 Years – 36 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-07-13
• Primary completion: 2022-04-04
• Completion: 2022-05-12
• First posted: 2025-10-08
• Last updated: 2025-10-08

Locations

3 sites across 1 country: Thailand