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:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT02757950
Eligibility Criteria:
Inclusion Criteria:
* Subjects between 18 and 45 years of age at the time of pregnancy under consideration for the study, who deliver in the study centre.
* Residents of the study area
* Subjects who were compliant with the routine antenatal care including at least one ultrasound assessment report early in the pregnancy.
* Subjects with the complete and relevant medical records available.
Inclusion criteria for the Exposed cohort:
* Subjects who received one dose of Refortrix vaccine in the recommended time period between 27 and 36 completed weeks of pregnancy (or as late as 20 days before delivery due date) as part of the maternal immunization program in Brazil, and according to the program recommendations from May 2015 onwards.
* Subjects with appropriate vaccination records.
Inclusion criteria for the Unexposed cohort:
* Subjects who had delivered in the same hospital (study centre) before 01 September 2014 (September 2012-August 2014) and who did not receive Tdap vaccination during pregnancy to the best knowledge of the investigator.
Exclusion Criteria:
* Subjects who have been transferred to other specialised centres, where their medical records would be inaccessible for the study (private clinics, psychiatric or prison hospitals, other state hospitals, etc).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02757950
Study Brief:
Protocol Section:
NCT02757950