MedTrace Logo

10-year Follow-up After a Single Dose Acellular Pertussis Vaccination

NCT06803524 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2025-06-11

No results posted yet for this study

Summary

This is a phase IV, open-label, non-randomized study to demonstrate superior immunogenicity and safety of a second booster dose of Pertagen® as compared to Adacel® at 10 years after the first booster vaccination and to evaluate the long-term persistence of specific antibodies induced by BioNet's recombinant aP (Pertagen®) and TdaP (Boostagen®) vaccines and a chemically-detoxified Tdap vaccine (Adacel®) at 10 years after the first booster in participants who were vaccinated in the phase II/III trial (Protocol No. TDA202).

Conditions

  • Pertussis

Interventions

BIOLOGICAL

Pertagen® vaccine

Pertagen® vaccine, manufactured by BioNet-Asia Co., Ltd., Bangkok, Thailand. The vaccine is presented in pre-filled syringe, each containing one human dose (0.5 mL) of aP vaccine.

BIOLOGICAL

Adacel® vaccine

Adacel® vaccine, manufactured by Sanofi Pasteur, Ltd, Toronto, Ontario, Canada. The vaccine is presented in a single-dose vial, each containing one human dose (0.5 mL) of Tdap vaccine.

Sponsors & Collaborators

  • BioNet-Asia Co., Ltd.

    collaborator INDUSTRY

  • Mahidol University

    lead OTHER

Principal Investigators

  • Punnee Pitisuttithum · Vaccine trial Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-13
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Thailand

Study Locations

More Related Trials

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 NCT06803524 on ClinicalTrials.gov