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.
Study Type
OBSERVATIONAL
Enrollment
500
Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous
Investigational Site
San Juan, Puerto Rico
RECRUITINGPercentage 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
Trial Transparency email recommended (Toll free number for US & Canada)
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.