Whooping cough shot: can a second booster a decade later restore stronger immunity?

NCT ID NCT06803524

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 08, 2026 · Last updated Oct 09, 2026 · Updated 1 time

Summary

This Phase 4 study compares two pertussis booster vaccines, Pertagen and Adacel, in 90 healthy adults who received a first booster 10 years earlier. Researchers measure antibody levels before and 28 days after a second booster to see which vaccine triggers a stronger immune response. The study also tracks how well antibodies from the original shots have lasted over the decade.

What this could mean

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

Active substance
Pertagen, a recombinant acellular pertussis vaccine, compared with Adacel, a standard Tdap vaccine
What this could lead to
If Pertagen produces stronger antibody responses than Adacel, it could offer a more effective way to protect adults from whooping cough when their immunity from earlier shots fades.
What could go wrong
This is a small Phase 4 study of 90 adults who already received a first booster a decade ago, so results may not apply to people with different vaccination histories. Antibody levels are a proxy for protection, and the study does not track whether participants actually avoid whooping cough.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

90 people

The number who actually took part.

Started

May 2025

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 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 obtained prior to study entry; 3. Healthy, as established by pertinent medical history and physical examination; 4. Capable of complying with study procedures and willing to provide with a blood sample; 5. For women with childbearing potential (i.e., urine pregnancy test will not be performed in females who have undergone sterilisation, hysterectomy or who are post-menopausal), must have a negative urine pregnancy test at enrollment and willing to take reliable birth control measures for one month following vaccination. Exclusion Criteria: A participant with following criteria at screening will not be eligible for participation: 1. Having received any pertussis vaccine since completion of 1-year follow-up visit in the initial TDA202 study; 2. Having experienced physician-diagnosed pertussis since completion of 1-year follow-up visit in the initial TDA202 study prior to enrollment; 3. Pregnant or breast-feeding women or female participants who intend to become pregnant during study period; 4. History of any significant medical illness such as, but not limited to, immune deficiency, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic, renal, or endocrine disorder, splenic or thymic functional abnormality as determined by the investigator based on medical history and physical examination that may interfere with the participant's safety and evaluation of investigational vaccines in this study; 5. History of allergy or hypersensitivity to any vaccine (including its component); 6. History of any serious adverse event or neurological adverse event after vaccination; 7. History of receiving blood or blood component or immunoglobulin within 3 months prior to enrollment; 8. 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 enrollment; 9. Having received any other vaccines within 28 days prior to enrollment (3 months for live- attenuated vaccines); 10. Plan to receive any other vaccine or plan to participate in another clinical trial with intervention during the study period; 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. Any progressive or severe neurological disorder such as seizure disorder or Guillain-Barré syndrome; 13. History of any illness or clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the volunteers due to participation in the study 14. Fever as defined by body temperature ≥ 38°C at the time of enrollment (This is a temporary exclusion criterion). Remark: If fever occurs at screening visit, the participant may be rescreened and enrolled at a later date at the discretion of the investigator, or withdrawn at the discretion of the investigator.

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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

  • Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok Noi, Bangkok Metropolis, 10700, Thailand

  • Vaccine Trial Centre

    Ratchathewi, Bangkok Metropolis, 10400, Thailand

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