Pregnancy and birth outcome assessment in a population-based cohort after exposure to Trumenba

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07AH09) meningococcus B, multicomponent vaccine

  meningococcus B, multicomponent vaccine
• Medical condition to be studied:
  Pregnancy

Population studied

• Short description of the study population:
  Women aged ≤ 49 years at the start of pregnancy and who were continuously enrolled in their healthcare system for 292 days prior to estimated start of pregnancy until pregnancy end date will be included. The 292 day period considers the 180 day period for receiving the three or two dose regimen (0, 2, 6 months or 0 and 6 months), an 84 day period (12 weeks) to account for irregular timing of vaccination schedules, and the 28 day period of exposure prior to the pregnancy. Women exposed to medications that present a known increased risk for fetal malformation will be retrospectively identified and excluded from the analysis after the data has been obtained. A woman may experience pregnancy episodes in the study period that are classified as gestational trophoblastic disease, ectopic pregnancy, induced abortions, and unknown or of uncertain outcome. These episodes will be excluded from the analysis after the data have been obtained.; Patients must meet all of the following inclusion criteria to be eligible for inclusion in the; study:; 1. Women aged ≤ 49 years at the start of pregnancy.; 2. Women who were continuously enrolled in their healthcare system for at least 292 days prior to estimated start of pregnancy (e.g., date of last menstrual period) until pregnancy end date.; 3. Eligible outcomes occurred between November 1, 2015 and October 31, 2020. ; Exclusion Criteria:; There are no exclusion criteria for enrollment into this prospectively-designed study. However, the data will be accessed retrospectively after exposures and outcomes have occurred. As a result, excluding subjects prior to study enrollment is not applicable. After data collection is complete and the algorithm is implemented, women exposed to medications that present a known increased risk for congenital anomalies or administered another meningococcal B vaccine (other than Trumenba) 28 days prior to LMP or during pregnancy or pregnancy episodes that are classified as gestational trophoblastic disease, ectop
• Age groups:
  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:
  1872

Study design details

• Main study objective:
  The study will examine the risk of pregnancy outcomes and birth outcomes in women and infants, respectively, exposed to Trumenba prior to or during pregnancy.
• Outcomes:
  Primary endpoints include live birth, spontaneous abortion, stillbirth and major congenital anomaly
• Data analysis plan:
  This study will estimate the incidence of live births, spontaneous abortions, stillbirths, and prevalence of major congenital anomalies among clinically-recognized pregnant women, and will compare the occurrence of these events among Trumenba vaccine exposed women and infants with those among women and infants not exposed to the Trumenba vaccine.

Documents

Study results

b1971052-report-body

Study report

b1971052-abstract

b1971052-additional-reports

Study, other information

b1971052-additional-reports.pdf