Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy

Launched by SANOFI · Feb 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a vaccine called Adacel, which protects against tetanus, diphtheria, and pertussis (whooping cough), when given to pregnant individuals starting from the 27th week of pregnancy until they give birth. The researchers want to compare the health outcomes of babies born to mothers who received the Adacel vaccine during pregnancy to those born to mothers who did not receive any Tdap vaccine. They will look at various pregnancy and birth outcomes to see if there are any differences between the two groups.

To participate in the trial, pregnant individuals must have had at least one prenatal visit before 27 weeks of pregnancy and be enrolled from 90 days before their last menstrual period through their delivery or termination of pregnancy. Unfortunately, those who have had a miscarriage or who are pregnant with multiples, among other criteria, will not be eligible. Participants can expect close monitoring throughout their pregnancy and after delivery to gather information about both their health and their baby’s health. This study is currently active but not recruiting new participants.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• * For pregnant individuals:
• • Continuous enrollment, with no more than a 1-month administrative gap from 90 days prior to their last menstrual period (LMP)
• • Continuous enrollment for the duration of their pregnancy through delivery or termination of pregnancy (or 6 weeks postpartum for preeclampsia/eclampsia and 28 days for PPH) unless censored at death in order to capture study outcomes
• • At least 1 prenatal visit prior to 27 weeks of gestation during pregnancy
• * For offspring:
• • Infants delivered by pregnant individuals who meet all the inclusion criteria above
• • With gestational age as calculated based on date of birth recorded in the EMR
• Exclusion Criteria:
• * For pregnant individuals:
• • Loss of pregnancy or with delivery before 27 weeks of gestation
• • Vaccinated with Boostrix® (Tdap vaccine, GSK), or with an unknown brand of Tdap vaccine, or Td (tetanus, diphtheria) vaccine during pregnancy
• • Vaccinated with any Tdap vaccine prior to the ACIP recommended optimal timeframe of ≥ 270/7 weeks of gestation
• • Received more than one Tdap vaccine during pregnancy
• • Vaccinated with one or more live vaccines during pregnancy
• • Pregnant individuals with multiple gestation pregnancies (eg, twins, triplets)
• * For offspring:
• • Infants delivered by pregnant individuals who meet any of the exclusion criteria above