A Pregnancy Registry to Evaluate the Safety of Dengue Vaccine Among Inadvertently Exposed Pregnant Women and Their Offsprings (DNG16)

DNG16

Primary Objective: To evaluate the safety of CYD-TDV in pregnant women and their offsprings inadvertently exposed during pregnancy or up to 30 days preceding their last menstrual period (LMP) with regards to maternal, pregnancy, birth, neonatal and infant outcomes. Specifically, the frequency/rates of these outcomes will be: (i) described, and (ii) compared with population-level background incidence rates prior to the introduction of CYD-TDV immunization (i.e., external unvaccinated comparator). Secondary Objective: To describe: * the characteristics of women exposed to CYD-TDV during pregnancy or up to 30 days before the LMP * the characteristics of CYD-TDV pregnancy exposure with regards to number of doses, dose intervals, and trimester of exposure.

2022-03-11

2023-03-27

2023-03-27

Completed

104

Inclusion criteria: * CYD-TDV exposed pregnant women of any age residing in the 30 municipalities of Paraná where public vaccination campaigns have been offered at the time of their pregnancy exposure, and whose pregnancy exposure was reported to Brazil's AEFI PV database (SI-PNI AEPV). * Valid contact information (in SI-PNI AEPV). * Study participants must provide a signed and dated informed consent form (ICF) or assent form (AF) (based on local regulations), and/or a signed and dated ICF by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations) if a minor (women who meet the inclusion criteria and provide informed consent to participate and complete the structured interview, but who do not consent to medical record review and/or database linkages will still be included in the study; however, their data will be analyzed separately in a sensitivity analysis). Exclusion criteria: - Presence of a major language barrier, medical or psychiatric condition that would prevent a woman from providing informed consent or accurate medical or medication/vaccination histories. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '22 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}, 'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'No biospecimens will be collected from participants, therefore, no biospecimens will be retained'}, 'enrollmentInfo': {'count': 104, 'type': 'ACTUAL'}}

2024-01-10