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Whooping cough vaccine in pregnancy: new study looks at how antibodies pass to babies

NCT ID NCT05856396

Knowledge-focused Sponsor: Centre Hospitalier Universitaire Saint Pierre 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at 200 women and their infants to understand how the whooping cough vaccine given during pregnancy affects the baby's immune protection. Researchers measured antibody levels in mothers and in umbilical cord blood at birth, as well as in infants after their own vaccines. The goal is to identify factors that influence how well protective antibodies are transferred from mother to child, which could improve vaccination strategies.

What this could mean

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

Active substance
Pertussis-containing vaccines (Triaxis® and Vaxelis®)
What this could lead to
If successful, this could help design better vaccination schedules for pregnant women to protect newborns from whooping cough.
What could go wrong
This is an observational analysis of an already completed study, not a test of a new treatment. Results may not lead to immediate changes in practice.

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

200 people

The number who actually took part.

Started

Sep 2023

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

2 months to 45 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: * For non-pregnant \& pregnant women Age between 18 and 45 years Eligible for Tdap vaccination * For infants Born to mothers vaccinated or not with Tdap Vaccinated with hexavalent vaccine Age between 2 and 3 months Exclusion Criteria: * For pregnant and non-pregnant women * Inability to understand the nature and extent of the study and the procedures required * Grade III/IV anemia, * Acute infection at the time of immunization * Chronic infections such as Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection, acute toxoplasmosis * Current or recent use of immunosuppressive drugs * Active neoplasia * Other vaccine(s) administered at the same time as Tdap vaccination (wash out of 4 weeks after others vaccinations and 28 days after Tdap vaccination ) * For pregnant women * Risk of premature delivery or intrauterine growth retardation * Twin or triplet pregnancies * For non-pregnant women Last Tdap vaccination \< 12 months before For infants: * Infants born before 35 weeks of gestation * Birthweight below 2.5 kg, * Severe neonatal distress * Serious congenital abnormalities or congenital infection.

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Conditions

The condition(s) this trial relates to.

Infections pertussis

As listed by the trial registrant

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

Immunoglobulins Maternal-fetal relations Pertussis Vaccination; infection

Contacts and locations

Locations

  • CHU Saint-Pierre

    Brussels, 1000, Belgium

More trials for these conditions

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