An OTIS/MotherToBaby Pregnancy Registry-based observational cohort study to evaluate pregnancy and infant outcomes in individuals exposed to Boostrix as of the 1st day of the 27th week of gestation in the US (EPI-PERTUSSIS-075 VS US PR 219588)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Boostrix

Population studied

• 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:
  3000

Study design details

• Main study objective:
  The main objective of the study is to evaluate if there are increased risks for preterm birth, small for gestational age infants, or stillbirth after Boostrix vaccination on or after the 1st day of the 27th week of pregnancy when compared to a cohort of pregnancies unexposed to any Tdap vaccine during pregnancy.
• Outcomes:
  Proportion of preterm birth, small for gestational age infants, or stillbirth in pregnancies exposed to Boostrix vaccination on or after the 1st day of the 27th week of gestation when compared to a cohort of individuals unexposed to any Tdap vaccine during their pregnancy. Proportion of preeclampsia/eclampsia, premature rupture of the membranes, chorioamnionitis, neonatal sepsis, neonatal death, or neonatal intensive care admission for bronchopulmonary dysplasia in pregnancies exposed to Boostrix vaccination on or after the 1st day of the 27th week of gestation when compared to a cohort of individuals unexposed to any Tdap vaccine during their pregnancy.
• Data analysis plan:
  A stepwise approach will be used for the analysis. The initial analysis will be descriptive and unadjusted. Where numbers permit, multivariable analyses will be conducted for the analyses to adjust for possible confounders.