N/A
Completed N=2,462
A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.
Source: ClinicalTrials.gov NCT02757950 ↗Enrolled (actual)
2,462
Serious AEs
—
Results posted
Oct 2019
Primary outcomePrimary: Number of Subjects Reporting Gestational Diabetes — 10; 22 Participants — p=0.1147
Summary
The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in a maternal immunization program in Brazil.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Gestational Diabetes |
10; 22 | 0.1147 |
| PRIMARY Number of Subjects Reporting Pregnancy-related Hypertension, Pre-eclampsia, Eclampsia, and HELLP Syndrome |
11; 31; 10; 30; 2; 0 | 0.0155 sig |
| PRIMARY Number of Subjects Reporting Pregnancy Hemorrhage |
4; 19 | 0.0127 sig |
| PRIMARY Number of Subjects With Pre-specified Neonate-related Outcomes Resulting in Preterm Birth |
64; 121 | 0.0036 sig |
| PRIMARY Number of Subjects With Pre-specified Neonate-related Outcomes, Resulting in Neonates Small for Their Gestational Age |
69; 62 | 0.0931 |
| SECONDARY Number of Subjects Reporting Pregnancy-related Adverse Events (AEs) of Interest/Neonate-related Events up to Delivery |
190; 261; 17; 36; 32; 54 | — |
| SECONDARY Number of Subjects Reporting Cases of Congenital Anomalies in the Neonates |
3; 22 | — |
| SECONDARY Number of Subjects With Pregnancy-related AEs and Birth Outcomes Per Calendar Year |
10; 12; 14; 17; 16; 3 | — |
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).
Data sourced from ClinicalTrials.gov (NCT02757950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.