CompletedNot Applicable

Safety Monitoring of VacPertagen Vaccine in Thailand

Thailand5,414 participantsStarted 2018-07-16

Plain-language summary

In compliance with Thailand's conditional approval requirements, this prospective, observational study is designed to actively monitor the safety of VacPertagen vaccine. Healthcare professionals (HCPs) prescribing or administering the vaccine are recruited from hospitals and clinics across central, eastern, southern and northern Thailand. Adverse events following immunization (AEFIs) are reported through standardized questionnaires and modified WHO AEFI forms, enabling systematic evaluation of the vaccine's safety profile in a broader and more heterogeneous population than that assessed in pre-licensure trials. Primary objective: To describe the post-licensure safety profile of VacPertagen in Thailand. Secondary objective: To identify any unexpected safety signals following vaccination with VacPertagen.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Has prescribed and/or administered VacPertagen to adults and adolescents in accordance with current national immunization guidelines.
. Employed full-or part-time (\> 8 hours/week) in a government or private hospital or medical clinic.
. Available for follow-up by telephone call, email or site visit if there are missing information in the study questionnaire, to confirm the occurrence or clarify the nature of an adverse event following immunization with VacPertagen.
. Willing and able to comply with the study procedures.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence and percentage of AEFIs following vaccination with VacPertagen.

Timeframe: From the date of vaccination up to 30 days post-vaccination.

Incidence and percentage of pregnant women vaccinated with VacPertagen who had experienced complications during pregnancy

Timeframe: From administration of VacPertagen during pregnancy until delivery

Incidence and percentage of healthy and not healthy infants born to mothers who received VacPertagen during pregnancy.

Timeframe: From maternal vaccination during pregnancy until birth of the infant.

Trial details

NCT IDNCT07400120

SponsorBioNet-Asia Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-02-21

View on ClinicalTrials.gov More Pertussis (Whooping Cough) trials