Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) … (NCT06258057) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy
France365,000 participantsStarted 2024-01-02
Plain-language summary
The purpose of this study is to evaluate the safety of Adacel vaccine among pregnant individuals exposed to Adacel at any point between the 1st day of the 27th week of gestation up to the end of pregnancy and their offspring (ie, Adacel-exposed cohort), in comparison with pregnant individuals not vaccinated with any Tdap vaccines during pregnancy and their offspring (ie, Tdap-unvaccinated comparator cohort).
The primary objectives are to estimate incidence rates and relative risks for each prespecified pregnancy outcome in Adacel-exposed and Tdap-unvaccinated comparator cohorts and for each prespecified adverse birth outcome in the offspring of both cohorts.
The secondary objectives are to estimate incidence rates and relative risks for each prespecified adverse fetal and neonatal outcome in the offspring of Adacel-exposed and Tdap unvaccinated comparator cohorts and for each prespecified adverse outcome for pregnant individuals in both cohorts.
Who can participate
Age range
15 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ≥ 27 0/7 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pregnancy outcome: Live birth
Timeframe: From 1st day of the 27th week of gestation up to 42 weeks gestation
2
Pregnancy outcome: Still birth/fetal demise
Timeframe: From 1st day of the 27th week of gestation up to 42 weeks gestation
3
Pregnancy outcome: Therapeutic abortion
Timeframe: From 1st day of the 27th week of gestation up to 42 weeks gestation
4
Birth outcome: Preterm birth
Timeframe: From 1st day of the 27th week of gestation and less than 37 weeks gestation
5
Birth outcome: Low birth weight
Timeframe: From 1st day of the 27th week of gestation up to 42 weeks gestation
6
Birth outcome: Small for gestational age
Timeframe: From 1st day of the 27th week of gestation up to 42 weeks gestation