Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT05040802
Eligibility Criteria:
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 unknown brand cases
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Days
Maximum Age:
2 Months
Study:
NCT05040802
Study Brief:
Protocol Section:
NCT05040802