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

Completed

• Conditions: Dengue Virus Infection
• Interventions: Drug: CYD-TDV Dengue Vaccine

• Registration Number: NCT04023708
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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).

Study Timeline

• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-07-16
• Study First Posted: 2019-07-17
• Study Start: 2022-03-11
• Primary Completion: 2023-03-27
• Study Completion: 2023-03-27
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort I: CYD-TDV exposed pregnant women and offspring	CYD-TDV Dengue Vaccine	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

Primary Outcome Measures

Name	Time	Method
Percentage of pregnant women with maternal adverse events	From cohort entry up to 42 days post-end of pregnancy	Maternal adverse events defined as all reported adverse events following immunization (serious and non-serious) occurring independent of the pregnancy (e.g., injection site reactions, systemic reactions)
Percentage of pregnant women with pregnancy related adverse events	From cohort entry to up to 42 days post-end of pregnancy	Pregnancy related adverse events defined as adverse event of special interest (AESI)s and other reported adverse events (serious and non-serious) occurring during the pregnancy, labour and delivery, or the puerperium
Percentage of offsprings with adverse neonatal events	From DOB up to 28 days post-birth	Adverse neonatal events defined as study AESIs and other reported adverse events (serious and non-serious) occurring between DOB and 28 days post-DOB
Percentage of offsprings with adverse birth outcomes	On day of birth (DOB)	Adverse birth coutcomes defined as study AESIs and other reported adverse events (serious and non-serious) observed or diagnosed at birth
Percentage of offsprings with adverse infant events	From day 29 post-birth up to 12 months post-birth	Adverse infants events defined as study AESIs and other reported adverse events (serious and non-serious) occurring between day 29 post-birth and 12 months post-birth

Trial Locations

Locations (1)

Universidade Federal do Paraná Site Number : 1; 🇧🇷 Curitiba, Paraná, Brazil