The MenQuadfi™ Pregnancy Registry: A surveillance registry to assess the safety of MenQuadfi™ among exposed pregnant women and their offspring (MEQ00070)

Study type

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

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  An observational, post-marketing, passive surveillance program to collect information on women and their offspring exposed to MenQuadfi™ during pregnancy. The reporting will be voluntary from women or their health care provider.

Study drug and medical condition

• Name of medicine:
  MENQUADFI
• Anatomical Therapeutic Chemical (ATC) code:
  (J07AH08) meningococcus A,C,Y,W-135, tetravalent purified polysaccharides antigen conjugated

  meningococcus A,C,Y,W-135, tetravalent purified polysaccharides antigen conjugated
• 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)

  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women

Study design details

• Main study objective:
  To assess maternal, obstetrical, pregnancy, neonatal and infant among women vaccinated with MenQuadfi™ during their pregnancy or within 30 days prior to their last menstrual period (LMP).
• Outcomes:
  The outcomes of interest will consist of any reported adverse event, including both symptoms, diagnoses, and normal outcomes following vaccination of a pregnant woman. Primary outcomes are classified as “maternal” if they impact maternal health but are independent of the pregnancy, “obstetrical” if they are related directly to the pregnancy, “pregnancy” if they are related to labor and delivery. Secondary outcomes will be any reported adverse event including both symptoms, diagnoses, and normal outcomes following vaccination of a pregnant woman, that will be classified as “neonatal” if related to the infant and assessed immediately after birth or within the first 28 days of life (e.g. congenital anomalies), and “infant” for those occurring / diagnosed between days 29 and 365 post-birth.
• Data analysis plan:
  The population of women exposed to MenQuadfi during pregnancy and their offspring will be reported using appropriate descriptive statistics. To assess the safety of MenQuadfi exposure during pregnancy, frequencies of SAEs observed among women enrolled in the pregnancy registry and their offspring and the corresponding 95% CIs will be compared qualitatively to those expected in the general US population of pregnant women prior to the availability of MenQuadfi.