NCT04486638

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
38mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Jan 2023Jun 2029

First Submitted

Initial submission to the registry

July 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
2.4 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

6.5 years

First QC Date

July 22, 2020

Last Update Submit

January 19, 2026

Conditions

Dengue Virus Infection

Outcome Measures

Primary Outcomes (5)

  • Percentage of pregnant women with maternal adverse events

    Maternal adverse events are reported as serious or non-serious

    From vaccination until end of follow-up (maximum 22 months after cohort entry)

  • Pecentage of women with obstetrical adverse events

    Obstetrical adverse events are collected during pregnancy, labour, delivery and puerperium, and are reported as serious or non-serious

    From vaccination until 1 month post-delivery

  • Percentage of participants with adverse pregnancy outcome

    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

    On day of birth

  • Percentage of offsprings with neonatal adverse events

    Neonatal events are reported as serious or non-serious

    From day of birth to 28 days post-birth

  • Percentage of offsprings with infant adverse events

    Infant events are reported as serious or non-serious

    From 29 days to 365 days post-birth

Study Arms (1)

Pregnant women and their offspring(s)

Women and their offspring(s) exposed to Dengvaxia during pregnancy

Biological: Dengue Tetravalent Vaccine, Live

Interventions

Dengue Tetravalent Vaccine, LiveBIOLOGICAL

Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous

Pregnant women and their offspring(s)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women of any age and their offspring(s) residing in the US and its Territories whose Dengvaxia pregnancy exposure is reported to the pregnancy registry

The eligible population will include pregnant women of any age and their offspring(s) residing in the US and its Territories whose Dengvaxia pregnancy exposure is reported to the pregnancy registry. Reports of Dengvaxia pregnancy exposure must contain the following information to be included in the registry: * Sufficient evidence to confirm the case qualifies as "exposed during pregnancy"; * Vaccine name (brand or generic) is provided (i.e., including manufacturer unknown exposures). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Investigational Site

San Juan, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Dengue

Interventions

Dengue Vaccines

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Central Study Contacts

Dengvaxia US Pregnancy Registry HelpLine

CONTACT

1-800-822-2463

Trial Transparency email recommended (Toll free number for US & Canada)

CONTACT

800-633-1610contact-us@sanofi.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
22 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 24, 2020

Study Start

January 1, 2023

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Locations

PR(1)