Last updated: 06/19/2023 11:50:09

Safety study of Boostrix in pregnant women

GSK study ID
219588
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: This study aims to determine whether risks of pregnancy and neonatal or early infancy safety outcomes are higher among pregnant people after receiving the Boostrix (Tdap) vaccine on or after the 1st day of the 27th week of pregnancy versus the non-vaccinated.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Proportion of preterm birth

Timeframe: From 1st day of 27th week of pregnancy or after until end of pregnancy

Proportion of small for gestational age infants

Timeframe: From 1st day of 27th week of pregnancy or after until end of pregnancy

Proportion of still birth

Timeframe: From 1st day of 27th week of pregnancy or after until end of pregnancy

Secondary outcomes:

Proportion of preeclampsia or eclampsia

Timeframe: From 1st day of 27th week of pregnancy or after until end of pregnancy

Proportion of premature rupture of membranes

Timeframe: From 1st day of 27th week of pregnancy or after until end of pregnancy

Proportion of chorioamnionitis

Timeframe: From 1st day of 27th week of pregnancy or after until end of pregnancy

Proportion of neonatal sepsis

Timeframe: From birth until 28 days of age

Proportion of neonatal death

Timeframe: From birth until 28 days of age

Proportion of neonatal intensive care admission for bronchopulmonary dysplasia

Timeframe: From birth until 28 days of age

Interventions:
  • Other: Data collection
    • Enrollment:
    3000
    Primary completion date:
    2026-21-09
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Whooping cough
    Product
    SB776423
    Collaborators
    Organization of Teratology Information Specialists (OTIS)/MotherToBaby
    Study date(s)
    June 2023 to September 2026
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female
    Age
    12 - 64 Years
    Accepts healthy volunteers
    Yes
    • All participants must meet the following criteria to be eligible for inclusion in the study:
    • Reside in the US at the time of enrollment
    • Cohort 1: Boostrix-Exposed group
    • Women who have previously been included in this study with a prior pregnancy.
    Inclusion and exclusion criteria
    Inclusion criteria:

      All participants must meet the following criteria to be eligible for inclusion in the study:

      • Reside in the US at the time of enrollment
      • Enrolled in the OTIS/MotherToBaby Pregnancy Registry and currently pregnant at the time of enrollment on or after 08 March 2004
      • Pregnancy ending in either livebirth or stillbirth
      • Availability of medical records for that pregnancy including from obstetric provider, hospital of delivery and pediatric provider Cohort 1: Boostrix-Exposed group
      • Currently pregnant women at the time of enrollment who contacted the OTIS/MotherToBaby Research Center and who have documented exposure to Boostrix brand Tdap vaccination on or after the 1st day of the 27th week of pregnancy.
      • Currently pregnant women at the time of enrollment who agreed to the conditions and requirements of the study including informed consent, the interview schedule and release of medical records.
      • Availability of obstetric, delivery and pediatric medical records for the enrolled pregnancy Cohort 2: Tdap Vaccine-Unexposed Comparator Group
      • Currently pregnant women at the time of enrollment who were not exposed to any Tdap vaccine from the first day of LMP to the end of pregnancy.
      • Currently pregnant women at the time of enrollment who agree to the conditions and requirements of the study including informed consent, the interview schedule and release of medical records.
      • Availability of obstetric, delivery and pediatric medical records for the enrollment pregnancy.
    Exclusion criteria:

      Cohort 1: Boostrix-Exposed group

      • Women who have previously been included in this study with a prior pregnancy. Cohort 2: Tdap Vaccine-Unexposed Comparator Group
      • Women who have received a Tdap vaccine anytime during pregnancy.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Will be recruiting
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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