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| ID | Type | Description | Link |
|---|---|---|---|
| DNG00044 | Other Identifier | Sanofi Identifier | |
| U1111-1243-6064 | Registry Identifier | ICTRP |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women and their offspring(s) | Women and their offspring(s) exposed to Dengvaxia during pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dengue Tetravalent Vaccine, Live | Biological | Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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.
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dengvaxia US Pregnancy Registry HelpLine | Contact | 1-800-822-2463 | ||
| Trial Transparency email recommended (Toll free number for US & Canada) | Contact | 800-633-1610 | option 6 | contact-us@sanofi.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Recruiting | San Juan | Puerto Rico |
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
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| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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| ID | Term |
|---|---|
| D053059 | Dengue Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |