The Safety of Boostrix Following Routine Immunization of Pregnant Women

Overview

The purpose of this study is to assess the safety of Boostrix administered on or after the first day of the 27th week of pregnancy by conducting a post-marketing study that will provide safety information to the public and healthcare providers. This will be one of the largest cohorts of pregnant women vaccinated with Boostrix in the U.S. Through partnership between Kaiser Permanente Southern California (KPSC) and the sponsor, GlaxoSmithKline (GSK), information about the safety of maternal vaccination with Boostrix and maternal and infant adverse events (AEs) in a community setting will be gained.

Full Title of Study: “An Observational, Retrospective Cohort Database Study to Assess the Safety of Boostrix (U.S. Formulation), a Reduced Tetanus, Diphtheria, Acellular Pertussis Vaccine (Tdap), Following Routine Immunization of Pregnant Women in the United States”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 4, 2020

Interventions

  • Other: Safety assessment following routine immunization with Boostrix
    • Subject-level data will be collected for pregnant women and their infants through the Electronic Health Records.

Arms, Groups and Cohorts

  • Exposed Group
    • Pregnant women vaccinated with Boostrix on or after the 1st day of the 27th week of pregnancy; who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy are in scope of this study.
  • Unexposed Group
    • Women matched to the exposed cohort and pregnant sometime during the approximate estimated period between 1/1/2012-12/31/2013 who did not receive any Tdap vaccine during the pregnancy are in scope of this study.

Clinical Trial Outcome Measures

Primary Measures

  • Number of subjects with maternal and infant adverse events.
    • Time Frame: After the index date, during pregnancy and at delivery
    • The number of subjects with maternal and infant adverse events (Preeclampsia and/or eclampsia, Intra-uterine infections such as chorioamnionitis and endometritis, Small for gestational age, Preterm delivery) among women who were vaccinated with Boostrix on or after the 1st day of the 27th week of gestation and their infant and among a historical comparison cohort, is tabulated.

Secondary Measures

  • Number of subjects with maternal and infant adverse events
    • Time Frame: After the index date, during pregnancy and up 6 months after delivery
    • The number of subjects with maternal and infant adverse events (Transfusion during delivery hospitalization as a proxy for severe post-partum hemorrhage , Poor fetal growth, Stillbirth/fetal death with or without congenital anomalies, Neonatal death within 28 days of birth, Maternal death while pregnant or within 42 days of end of pregnancy, Placental abruption, Preterm pre-labor rupture of membranes, Congenital anomalies at birth and through 6 months of age) among women who were vaccinated with Boostrix on or after the 1st day of the 27th week of gestation and their infant and among a historical comparison cohort, is tabulated. The number of subjects with Spontaneous abortion (only for women exposed to Boostrix before the 27th week of gestation), Therapeutic abortion (only for women exposed to Boostrix before the 27th week of gestation) is tabulated.

Participating in This Clinical Trial

Inclusion Criteria

  • Pregnant women with prenatal care and continuous membership (allowing up to a 31-day gap) at KPSC between the 1st day of the 27th week of pregnancy and the index (vaccination) date. – Exposed cohort (from the 27th week of gestation): Pregnant women vaccinated with Boostrix on or after the 1st day of the 27th week of pregnancy; who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy in scope of this study. – Unexposed cohort: Women matched to the exposed cohort and pregnant sometime during the approximate estimated period between 1/1/2012-12/31/2013 and did not receive any Tdap vaccine during the pregnancy in scope of this study. For the analysis of congenital anomalies among live births, at birth and through six months of age, the following additional inclusion criteria for infants will be applied: – Live born – Born in KPSC hospitals Note: Pregnant women vaccinated with Boostrix during pregnancy before the 27th week of gestation, with membership at the date of vaccination, and who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy in scope of this study will be part of a descriptive analysis (secondary objective).

Gender Eligibility: Female

Pregnant women with prenatal care and continuous membership (allowing up to a 31-day gap) at KPSC between the 1st day of the 27th week of pregnancy and the index (vaccination) date.

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Collaborator
    • Kaiser Permanente
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

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