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 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT03973905
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for case infants:
* Case infants were eligible for the enrolment if they:
* were at least 2 days old and \< 2 months old on the cough onset date
* resided in the catchment area on their cough onset date
* were born in a hospital in their state of residence
* were ≥37 weeks' gestational age at birth
* were neither adopted nor in foster care
* did not live in a residential care facility
Inclusion criteria for control infants:
* Control infants were eligible for the enrolment if they:
* were at least 2 days old and \<2 months old on the case infant's cough onset date
* were born in a hospital in their state of residence
* were ≥37 weeks' gestational age at birth
* were neither adopted nor in foster care
* did not live in a residential care facility
* were born at the same hospital as the case infant
did not have pertussis diagnosis prior to the cough onset date of the corresponding case infant
Exclusion Criteria:
* Infants (case and controls) whose mothers have received Adacel or mothers without brand information available, as well as controls who were matched to a case whose mother received Adacel or mothers without brand information available, will be excluded from the analysis of the effectiveness of vaccination with Boostrix.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Days
Maximum Age:
2 Months
Study:
NCT03973905
Study Brief:
Protocol Section:
NCT03973905