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Thousands monitored: is the whooping cough vaccine safe in real life?

NCT ID NCT07444502

Vaccine Sponsor: BioNet-Asia Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study tracked over 10,000 people in Thailand who received the Boostagen® vaccine, which protects against tetanus, diphtheria, and whooping cough. Healthcare workers reported any side effects to see how safe the vaccine is in everyday use. The study also looked at pregnant women and their newborns to check for any complications. The goal is to ensure the vaccine remains safe after being approved for the public.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Boostagen® (combined tetanus, diphtheria, and acellular pertussis vaccine)
What this could lead to
If successful, this study will confirm that Boostagen® is safe for widespread use, including in pregnant women, helping protect against whooping cough, tetanus, and diphtheria.
What could go wrong
This is an observational safety study, not a test of effectiveness. It may not detect rare side effects, and results are specific to Thailand's population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

10,727 people

The number who actually took part.

Started

Jun 2017

Finished

Mar 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of a cohort of HCPs working in private and government hospitals and clinics in central, eastern, northern and southern Thailand where Boostagen® vaccine is marketed. An HCP is defined as medically qualified person, such as physician, nurse or pharmacist.

Ages

3 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: An HCP will be eligible for inclusion if ALL of the following criteria are met at the time of screening: 1. Has prescribed and/or administered Boostagen® to children, adolescents and adults in accordance with current national immunization guidelines. 2. Employed full-or part-time (\> 8 hours/week) in a government or private hospital or medical clinic. 3. 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 Boostagen®. 4. Willing and able to comply with the study procedures. Exclusion Criteria: * Unwilling to take part in the study.

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Conditions

The condition(s) this trial relates to.

diphtheria prevention target pertussis prevention target tetanus prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diphtheria Pertussis (whooping cough) Tetanus

Contacts and locations

Locations

  • BioNet-Asia Co., Ltd.

    Bangkok, 10260, Thailand

More trials for these conditions

Other studies related to the condition(s) this trial covers.