Second Booster Dose of Pertagen® for Pertussis

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

Recruiting Phase 4 Interventional Study
Pertussis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Prevention
Participants needed
126 (estimated)
Sponsor
Mahidol University · Other
Who this trial is looking for

This trial is looking for participants who have taken part in an earlier study and received a vaccine. Participants will provide a blood sample and may receive a second booster dose of Pertagen® after ten years.

Are You a Good Fit for This Trial?

You may be able to join if

  • I participated in the initial study and completed the follow-up visit.
  • I am healthy according to my medical history and physical exam.
  • I can follow study procedures and give a blood sample.
  • I have a negative urine pregnancy test if I could become pregnant.
  • I will use reliable birth control for one month after vaccination.

You may not be able to join if

  • I have received any pertussis vaccine since the initial study follow-up.
  • I have had pertussis diagnosed by a doctor since the initial study.
  • I am pregnant or breastfeeding.
  • I have a history of significant medical illnesses that may affect safety.
  • I have allergies to any vaccine or its components.
  • I have had serious side effects from vaccines before.
  • I have received blood products or immunoglobulin in the last 3 months.
  • I have taken immunosuppressive drugs or corticosteroids in the last 3 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
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 (Ada…
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: A participant will be eligible for inclusion if ALL of the following apply at the time of screening: 1. 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; 2. Written informed consent is o…
Contacts

Punnee Pitisuttithum

0818294906

punnee.pit@mahidol.ac.th

CONTACT

Jittima Dhitavat

0875921777

่jittima_pu@yahoo.com

CONTACT