Dengvaxia US Pregnancy Registry

Recruiting

• Conditions: Dengue Virus Infection
• Interventions: Biological: Dengue Tetravalent Vaccine, Live

• Registration Number: NCT04486638
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

The primary objective of this study is to assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women and their offspring(s) vaccinated with Dengvaxia during their pregnancy

Detailed Description

Exposed pregnant women will be followed up to the end of their pregnancy, and the offspring(s) will be followed up to 1 year of age.

Study Timeline

• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-24
• Study Start: 2023-01-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2029-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women and their offspring(s)	Dengue Tetravalent Vaccine, Live	Women and their offspring(s) exposed to Dengvaxia during pregnancy

Primary Outcome Measures

Name	Time	Method
Percentage of pregnant women with maternal adverse events	From vaccination until end of follow-up (maximum 22 months after cohort entry)	Maternal adverse events are reported as serious or non-serious
Pecentage of women with obstetrical adverse events	From vaccination until 1 month post-delivery	Obstetrical adverse events are collected during pregnancy, labour, delivery and puerperium, and are reported as serious or non-serious
Percentage of participants with adverse pregnancy outcome	On day of birth	Adverse pregnancy outcomes include ectopic pregnancy, elective/induced abortion with no fetal defect(s) or fetus status unknown, elective/induced abortion with fetal defect(s), spontaneous abortion/miscarriage (\<20 weeks), stillbirth/fetal death at 20-27 weeks, fetal death at ≥28 weeks, and fetal death due to maternal death
Percentage of offsprings with infant adverse events	From 29 days to 365 days post-birth	Infant events are reported as serious or non-serious
Percentage of offsprings with neonatal adverse events	From day of birth to 28 days post-birth	Neonatal events are reported as serious or non-serious

Trial Locations

Locations (1)

Investigational Site; 🇵🇷 Puerto Rico, Puerto Rico