Dengue Virus Infection
Conditions
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.
Interventions
BIOLOGICALDengue Tetravalent Vaccine, Live
Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 neonatal adverse events | From day of birth to 28 days post-birth | Neonatal events are reported as serious or non-serious |
| Percentage of offsprings with infant adverse events | From 29 days to 365 days post-birth | Infant events are reported as serious or non-serious |
Countries
Puerto Rico
Contacts
CONTACTDengvaxia US Pregnancy Registry HelpLine
CONTACTTrial Transparency email recommended (Toll free number for US & Canada)
STUDY_DIRECTORClinical Sciences & Operations
Sanofi
Outcome results
None listed