Fluarix®/ FluLaval®/ Fluarix® Quadrivalent/FluLaval® Quadrivalent Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with Fluarix® or Fluarix® Quadrivalent or FluLaval® or FluLaval® Quadrivalent during pregnancy or within 28 days preceding conception

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

  Other
• If ‘other’, further details on the scope of the study:
  Detect/describe abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with any of GlaxoSmithKline (GSK) Biologicals’ seasonal Inactivated Influenza Vaccines: Fluarix, FluLaval, Fluarix Quadrivalent and FluLaval Quadrivalent
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Abortion spontaneous

  Stillbirth

  Selective abortion

  Abortion induced

  Live birth

Population studied

• Short description of the study population:
  In the US, the GSK sIIVs are indicated for prevention of disease caused by influenza A subtype viruses and type B virus lineages contained in the vaccine. GSK sIIVs are approved for use in persons 3 years of age (Fluarix) and older or 6 months of age and older (FluLaval or Fluarix Quadrivalent or FluLaval Quadrivalent). The study population included women vaccinated with any of the four GSK sIIVs during pregnancy or within 28 days preceding conception.; ; Inclusion criteria; A subject was included in the Registry if all the following criteria were met:; • Exposure to GSK sIIVs occurred during pregnancy or within 28 days preceding conception.; • Subject was a US resident.; • HCP was identified (name, address and phone number).; • Subject could be identified (by GSK or HCP).; Data from registered subjects were included in the analyses if the following criterion was met:; • Pregnancy was ongoing and the outcome was unknown at the time of initial report.; ; Exclusion criterion; Data from registered subjects were not included in the analyses if the following criterion was met:; • Pregnancy outcome was known at the time of the initial report. Types of known outcomes included prenatal testing reports in which the results were abnormal or outside the reference range, indicating possible abnormality in the fetus.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1

Study design details

• Main study objective:
  To describe the characteristics and proportion of prospectively reported pregnancies (women vaccinated with Fluarix or FluLaval or Fluarix Quadrivalent or FluLaval Quadrivalent during pregnancy or within 28 days preceding conception) with abnormal pregnancy outcomes.
• Outcomes:
  Occurrence of abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with Fluarix or FluLaval or Fluarix Quadrivalent or FluLaval Quadrivalent during pregnancy or within 28 days preceding conception during 2 months of and up to 12 months after the estimated date of delivery (EDD).
• Data analysis plan:
  Pregnancy outcomes include spontaneous abortion and fetal deaths/stillbirths (pregnancy loss before and at or after 22 weeks gestation, resp), elective/therapeutic abortions and live births. The presence or absence of birth defects or other abnormalities is evaluated within each of the preceding outcome categories.Pregnancy outcomes are stratified by the (earliest) trimester of exposure, with an additional stratum for preconception exposure with no subsequent administration of vaccine during pregnancy. The calculations of risk for birth defects are made by dividing the number of infants with birth defects by the total number of infants reported. An exact 95% confidence interval is calculated using standard statistical software. The outcomes of the study will be assessed against known rates from an external reference group for the likelihood of a safety signal warranting further investigation.Spontaneous abortions without birth defects are excluded from the risk calculations.

Documents

Study results

gsk-201476-clinical-study-report-redact

Study publications

Nwoji U. Seasonal influenza vaccine exposure in pregnancy: 5-year results from …