Massive U.S. study to see if whooping cough vaccine is safe for pregnant women and babies

NCT ID NCT06258057

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

Summary

This study is using electronic medical records from about 365,000 pregnant women in the U.S. to check the safety of the Adacel vaccine, which protects against tetanus, diphtheria, and whooping cough. Researchers will compare pregnancy and birth outcomes between women who got the vaccine after 27 weeks of pregnancy and those who didn't get any Tdap vaccine. The goal is to see if the vaccine is linked to any risks like preterm birth or low birth weight.

What this could mean

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

Active substance
Adacel (tetanus, diphtheria, acellular pertussis vaccine with 5 pertussis components)
What this could lead to
If this study finds no safety concerns, it could reassure pregnant women and doctors that the Tdap5 vaccine is safe to use during pregnancy, helping protect newborns from whooping cough.
What could go wrong
This is an observational study using existing medical records, not a controlled trial, so it can only show links, not cause and effect. Results may be affected by differences between the groups that aren't accounted for.

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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

  • Investigational Site

    Chilly-Mazarin, 91380, France

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