Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants < 2 Months of… (NCT05040802) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants < 2 Months of Age in the United States
France462 participantsStarted 2021-06-02
Plain-language summary
The purpose of this study is to determine the effectiveness of Adacel against pertussis disease in infants \< 2 months when administered during pregnancy following the current Advisory Committee on Immunization Practices (ACIP) recommendations, i.e., from 27 to 36 weeks of gestation, and 14 days or more before delivery.
Who can participate
Age range
2 Days – 2 Months
Sex
ALL
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:
Cases were included if they met the following inclusion criteria:
* Reported pertussis disease in the referenced EIP surveillance database
* Age greater than 2 days and younger than two months of age
* Resided in the catchment area on date of onset of their cough
* Born in a hospital in their state of residence
* ≥ 37 weeks of gestation at birth
* Not adopted, in foster care or living in a residential care facility
* Completed maternal interview
* Completed infant and maternal information
Controls were included if they met the following inclusion criteria:
* Age greater than 2 days and younger than 2 months of age on date of cough onset for the corresponding case infant
* Resided in the catchment area on date of cough onset for the corresponding case infant
* Born in a hospital in their state of residence
* ≥ 37 weeks of gestation at birth
* Not adopted, in foster care or living in a residential care facility
* Maternal interview completed
* Infant and maternal information complete
Exclusion Criteria:
Cases were excluded if they met any of the following exclusion criteria:
* Vaccination status of the mother unknown
* Infants whose mothers were vaccinated with Boostrix or an unknown vaccine brand
Controls were excluded if they met any of the following exclusion criteria:
* Vaccination status of the mother unknown
* A pertussis diagnosis prior to the cough onset date of the corresponding case infant
* Controls that were matched to Boostrix or an unk…
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
Number of pertussis cases in infants less than 2 months and matched controls
Timeframe: During the data collection period (from 01 January 2011 to 31 December 2014)