New whooping cough vaccine passes major safety check in thousands of adults
NCT ID NCT06798831
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This large Phase 3 trial is testing the safety of a new recombinant pertussis (whooping cough) vaccine in 2,399 healthy adults aged 18 to 75. Participants receive a single booster dose, and researchers monitor for side effects over 28 days. The goal is to confirm the vaccine is safe and consistent across different manufacturing lots.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Recombinant acellular pertussis (aP) vaccine (Pertagen®)
- What this could lead to
- If successful, this could provide a safer, well-tolerated whooping cough booster for adults, helping reduce spread and protect vulnerable populations.
- What could go wrong
- This is a safety-focused trial, not designed to prove effectiveness. Rare side effects may still emerge, and results may not apply to children or older adults.
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.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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2,399 people
The number who actually took part.
- Started
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Feb 2025
- Expected to finish
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Oct 2025
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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18 to 75 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 adult participant will be eligible for inclusion if ALL of the following criteria are met at the time of screening: 1. Aged 18 to 75 years (less than 76 years full of age) on the day of inclusion; 2. Can provide written informed consent; 3. Healthy, as established by pertinent medical history and physical examination; 4. Capable of complying with the study protocol and procedures; 5. For women with childbearing potential (i.e., urine pregnancy test will not be performed in females who have undergone sterilization, hysterectomy or who are post-menopausal.), must have a negative urine pregnancy test at enrollment. Exclusion Criteria: * A participant with ANY of the following criteria at study entry will not be eligible for participation: 1. History of significant medical illness such as but not limited to immune deficiency, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic, renal, splenic or thymic functional abnormality as determined by the investigator based on medical history and physical examination. For those cases that are clinically stable, the investigator may include them as deemed per medical judgement. 2. Breastfeeding women or female participants who intend to become pregnant during the study period; 3. History of a severe allergic reaction to any vaccine (including its components); 4. History of serious adverse event or neurological adverse event to any vaccination; 5. Receipt of any investigational product or licensed vaccine within 30 days prior to enrollment (3 months for live-attenuated vaccines); 6. Plan to receive tetanus, diphtheria or pertussis vaccine or plan to participate in other clinical trial during the study period; 7. Having experienced physician-diagnosed pertussis within 5 year prior to enrollment; 8. Receipt of diphtheria or tetanus or pertussis vaccine within 5 years prior to enrollment; 9. Having any progressive or severe neurologic disorder, seizure disorder or recent history of Guillain-Barré syndrome; 10. Medically significant cancer (except for benign or localized skin cancer, cancer in remission for ≥10 years); 11. A known bleeding diathesis or any condition that may be associated with a prolonged bleeding time resulting in a problem with intramuscular injection; 12. Suspected or known alcoholism and/or illicit drug abuse within the past 5 years; 13. Administration of immunoglobulins and/or any blood products within 3 months preceding study entry or planned administration during the study period; 14. History of receiving immunosuppressive drugs or systemic corticosteroid (\>0.5 mg/kg of prednisolone or equivalent for more than 14 days) within 3 months prior to study entry; 15. Has any active clinically significant finding or life-threatening disease that, in the opinion of the investigator, would increase the risk of the individual's having an adverse outcome by participating in this 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
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Chula Clinical Research Center (Chula CRC)
Bangkok, Bangkok, 10330, Thailand
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Queen Saovabha Memorial Institute, Thai Red Cross Society
Bangkok, Bangkok, 10330, Thailand
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Thai Red Cross AIDS and Infectious Diseases Research Centre
Bangkok, Bangkok, 10330, Thailand