A Pregnancy Registry to Evaluate the Safety of Dengue Vaccine among Inadvertently Exposed Pregnant Women and their Offsprings

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  DENGVAXIA
• Medical condition to be studied:
  Exposure during pregnancy

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  214

Study design details

• Main study objective:
  To evaluate the safety of CYD-TDV in pregnant women and their offsprings inadvertently exposed during pregnancy or up to 30 days preceding their last menstrual period (LMP) with regards to maternal, pregnancy, birth, neonatal and infant outcomes.
• Outcomes:
  The primary study endpoints will include all serious and non-serious maternal, pregnancy related, birth outcomes, neonatal and infant events occurring anytime between cohort entry and the end of follow-up for each event. Participant unique anonymized identifier, relevant maternal baseline characteristics, maternal data (type of conception, date of LMP, and estimated date of delivery), characteristics of prenatal care, characteristics of CYD-TDV exposure (dates doses administered, number of doses, dose intervals, and timing of pregnancy exposure), offspring data (sex, length, weight, and breastfeeding history).
• Data analysis plan:
  To assess the safety of CYD-TDV exposure during pregnancy, descriptive analyses will be undertaken to summarize the maternal, pregnancy, birth, neonatal and infant outcome data using frequencies expressed as absolute risk estimates with corresponding 95% CIs, and these data will be compared background incidence rates for the age-matched population in Paraná prior to the availability of CYD-TDV (i.e. unvaccinated comparator population). In addition, analyses will be stratified by reporting status (prospective vs. retrospective), as well as by trimester of exposure, with an additional stratum for periconceptional exposure. Reports of multiple CYD-TDV exposures during a pregnancy will be classified according to the earliest pregnancy exposure. Descriptive analyses will also be undertaken to characterize pregnancy exposure with regards to number of doses received, dose intervals and trimester of exposure, as well as the population of pregnant women inadvertently exposed to CYD-TDV.

Documents

Study report

rdct-dng16-csr-synopsis.pdf