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

ConditionPertussis

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorMahidol University

About this trial

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).

Eligibility criteria

Qualifiers

Having participated in the initial TDA202 study, received a single dose of one of the 3 study vaccines, and completed 1-year follow-up visit;

Written informed consent is obtained prior to study entry;

Healthy, as established by pertinent medical history and physical examination;

Capable of complying with study procedures and willing to provide with a blood sample;

Disqualifiers

Having received any pertussis vaccine since completion of 1-year follow-up visit in the initial TDA202 study;

Having experienced physician-diagnosed pertussis since completion of 1-year follow-up visit in the initial TDA202 study prior to enrollment;

Pregnant or breast-feeding women or female participants who intend to become pregnant during study period;

History of any significant medical illness such as, but not limited to, immune deficiency, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic, renal, or endocrine disorder, splenic or thymic functional abnormality as determined by the investigator based on medical history and physical examination that may interfere with the participant's safety and evaluation of investigational vaccines in this study;

Trial design

Treatments tested in this trial

Pertagen® vaccine
Adacel® vaccine

Treatment groups

126 Participants

are divided into 3 treatment groups

Sponsors and collaborators

Mahidol University

Lead sponsor

BioNet-Asia Co., Ltd.

Collaborator

Source ClinicalTrials.gov