A Prospective Observational Safety Study on Pregnancy Outcomes in Women Immunized With Seasonal Cell Culture Influenza Trivalent (TIVc) or Quadrivalent (QIVc) Vaccine During Pregnancy (Flucelvax (TIVc or QIVc) Pregnancy Registry)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• 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:
  Cohort

Study drug and medical condition

• Name of medicine:
  FLUCELVAX
• Medical condition to be studied:
  Influenza immunisation

Population studied

• Short description of the study population:
  The study population will include pregnant women within the US who were immunized with the TIVc or QIVc vaccine as part of routine care at any time during pregnancy. Eligible pregnant women may self-enroll or voluntarily be enrolled by their health care provider (HCP). Women under 18 can be included in the study as long as parental consent can be obtained.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  693

Study design details

• Main study objective:
  To evaluate pregnancy outcomes as well as events of interest of major congenital malformations, preterm birth and low birth weight among women immunized as part of routine care with the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy
• Outcomes:
  Number of cases for pregnancy outcomes will be reported as one of the following: live birth, stillbirth, spontaneous abortion and elective termination. Number of cases with major congenital malformations, events of preterm birth, and low birth weight among women immunized as part of routine care with the seasonal TIVc or QIVc vaccine during pregnancy.
• Data analysis plan:
  This study is descriptive. Data analysis will be performed for both products combined as well as per product separately, if applicable. Overall and stratum-specific prevalence estimates will be calculated for pregnancy outcomes and events of interest. Associations between exposure and pregnancy outcomes or events of interest, will be evaluated for confounding and effect modification.