Observational Study to Evaluate the Safety of CYD Tetravalent Dengue Vaccine (CYD-TDV) in Pregnant Women and Their Offsprings Inadvertently Exposed During Pregnancy

NCT ID: NCT04023708

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-11
• Study Completion Date: 2023-03-27

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 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.

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 retrospective (outcomes occurred before the start of participant enrollment) and prospective (outcomes occurred after the start of participant enrollment) cohort study using active identification and enrollment of pregnant women and their offsprings inadvertently exposed to CYD-TDV during pregnancy or up to 30 days preceding the LMP.

The study period will be from July 2016 (first availability of Paraná's Immunization Registry) to July 2022 (end of last follow-up interview for offsprings), and the participant enrollment period will last approximately 1 year.

Study duration per participant will vary depending on: 1) the stage of pregnancy at the time the participant will be enrolled; 2) whether the participant will be included retrospectively or prospectively. The maximum duration will be 22.5 months (up to 9 months of pregnancy + 42 days post-delivery [puerperium period] + 12 months post-birth).

Conditions

Dengue Virus Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Cohort I: CYD-TDV exposed pregnant women and offspring

Pregnant women of any age and their offspring who were inadvertently exposed to CYD-TDV anytime during the pregnancy or in the 30 days preceding their LMP

CYD-TDV Dengue Vaccine

Intervention Type: DRUG

Pharmaceutical form:Solution Route of administration: Intramuscular

Interventions

CYD-TDV Dengue Vaccine

Pharmaceutical form:Solution Route of administration: Intramuscular

Intervention Type: DRUG

Other Intervention Names

Dengvaxia®

Eligibility Criteria

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).

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi Pasteur, a Sanofi Company

Locations

Universidade Federal do Paraná Site Number : 1

Curitiba, Paraná, Brazil

Countries

Brazil

Other Identifiers

U1111-1217-3443

Identifier Type: REGISTRY

Identifier Source: secondary_id

DNG16

Identifier Type: -

Identifier Source: org_study_id