Thousands monitored: is the whooping cough vaccine safe in real life?
NCT ID NCT07444502
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
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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.
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