COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER)

Study type

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

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  COVID-19 immunisation

Population studied

• Age groups:
  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  The objective of the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) is to evaluate obstetric, neonatal, and infant outcomes among women vaccinated during pregnancy with a COVID-19 vaccine.
• Outcomes:
  Multiple obstetric, neonatal, and infant outcomes.
• Data analysis plan:
  To assess the effect of each COVID-19 vaccine brand on pregnancy outcomes, the risk of pregnancy outcomes among women exposed to a COVID-19 vaccine (from Cohort 1) at specific times during pregnancy will be compared to a reference group of women who have not received a COVID-19 vaccine during pregnancy up to that point, matched 1:2 on country of residence and gestational age at enrollment (±2 weeks).

Documents

Study, other information

InitialReviewNotice_37742718

IRB_Approval_11March2022