An observational study in Dengue Virus Infection, sponsored by Sanofi Pasteur, a Sanofi Company. Recruiting at 1 site in Puerto Rico. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Observational
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
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.
283 studies on the registry are indexed under Dengue; 44 are open to participants now.
This study's planned enrollment of 500 is below the median of 595 across 80 observational studies indexed under Dengue.
Browse Dengue studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
First submitted after Sanofi Pasteur became part of Sanofi.
Counted across the registry records on this site, refreshed daily.
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:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Women and their offspring(s) exposed to Dengvaxia during pregnancy
Biological: Dengue Tetravalent Vaccine, Live
Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous
Percentage of pregnant women with maternal adverse events
Maternal adverse events are reported as serious or non-serious
Time frame: 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
Time frame: 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
Time frame: On day of birth
Percentage of offsprings with neonatal adverse events
Neonatal events are reported as serious or non-serious
Time frame: 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
Time frame: From 29 days to 365 days post-birth
Plan to share: Yes — 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
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Sanofi Pasteur, a Sanofi Company →