Status:
COMPLETED
Observational Study to Evaluate the Safety of CYD Tetravalent Dengue Vaccine (CYD-TDV) in Pregnant Women and Their Offsprings Inadvertently Exposed During Pregnancy
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Dengue Virus Infection
Eligibility:
FEMALE
Brief Summary
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 re...
Detailed Description
This is a non -interventional (observational) post authorization safety study (PASS): no vaccine will be administered as part of the study. This pregnancy registry study is a combination of a retrosp...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 11 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 27 2023
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04023708
Start Date
March 11 2022
End Date
March 27 2023
Last Update
January 10 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Universidade Federal do Paraná Site Number : 1
Curitiba, Paraná, Brazil, 80010-200