Clinical Trial: A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: A Post-marketing, Observational, Retrospective, Cohort Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.

Brief Summary: The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in a maternal immunization program in Brazil.

Detailed Summary: In this retrospective cohort study the safety of RefortrixTM (Tdap) administered during pregnancy as part of the National immunization program in Brazil will be assessed by comparing the risk of pre-defined adverse events before and after introduction of the RefortrixTM (Tdap) maternal immunization program.
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Occurrence of any of the pre-specified pregnancy-related AEs in Exposed and Unexposed subjects [ Time Frame: Week 27 of pregnancy ]
    Gestational diabetes, Pregnancy-related hypertension (including pre-eclampsia, eclampsia and HELLP syndrome), Pregnancy haemorrhage (ante-partum (after 24 weeks of gestation), intra-partum or post-partum)
  • Occurrence of pre-specified neonate-related outcomes in neonates from Exposed and Unexposed subjects [ Time Frame: For pre-term birth: Week 27 up to week 37 of pregnancy. For small for gestational age: Week 27 of pregnancy ]
    Preterm birth, Small for gestational age


Original Primary Outcome:

  • Occurrence of any of the pre-specified pregnancy-related AEs in Exposed and Unexposed subjects [ Time Frame: After week 27 of pregnancy ]
    Gestational diabetes, Pregnancy-related hypertension (including pre-eclampsia, eclampsia and HELLP syndrome), Pregnancy haemorrhage (ante-partum (after 24 weeks of gestation), intra-partum or post-partum)
  • Occurrence of pre-specified neonate-related outcomes in neonates from Exposed and Unexposed subjects [ Time Frame: For pre-term birth: After week 27 up to week 37 of pregnancy. For small for gestational age: After week 27 of pregnancy ]
    Preterm birth, Small for gestational age


Current Secondary Outcome:

  • Occurrence of pregnancy-related AEs of interest/neonate-related events up to delivery in Exposed and Unexposed subjects [ Time Frame: Week 27 ]
    Premature rupture of membranes, Preterm premature rupture of membranes, Premature uterine contraction, Neonatal death, Maternal death, Still birth, Neonatal hypoxic ischaemic encephalopathy
  • Occurrence of congenital anomalies in the neonates of Exposed and Unexposed subjects [ Time Frame: Week 27 up to birth ]
  • Occurrence of pregnancy-related AEs and birth outcomes per calendar year in the Unexposed cohort [ Time Frame: Week 27 ]


Original Secondary Outcome:

  • Occurrence of pregnancy-related AEs of interest/neonate-related events up to delivery in Exposed and Unexposed subjects [ Time Frame: After week 27 ]
    Premature rupture of membranes, Preterm premature rupture of membranes, Premature uterine contraction, Neonatal death, Maternal death, Still birth, Neonatal hypoxic ischaemic encephalopathy
  • Occurrence of congenital anomalies in the neonates of Exposed and Unexposed subjects [ Time Frame: After week 27 up to birth ]
  • Occurrence of pregnancy-related AEs and birth outcomes per calendar year in the Unexposed cohort [ Time Frame: After week 27 ]


Information By: GlaxoSmithKline

Dates:
Date Received: April 28, 2016
Date Started: May 6, 2016
Date Completion: May 31, 2017
Last Updated: May 16, 2017
Last Verified: May 2017