Last updated: 05/17/2022 08:00:08

The safety of Boostrix following routine immunization of pregnant women

GSK study ID
207221
See study documents
Clinicaltrials.gov ID
NCT03463577
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: The purpose of this study was 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 provided safety information to the public and healthcare providers. This was 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 was gained.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Incidence rate (per 1000 person-years) of pre-specified maternal adverse events for Exposed cohort women-on or after 1st day of 27th week of pregnancy and Unexposed historical cohort-women Groups

Timeframe: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeks

Incidence rate (per 1000 persons) of prespecified maternal adverse events for Exposed cohort women-on or after 1st day of 27th week of pregnancy and Unexposed historical cohort women Groups

Timeframe: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeks

Incidence rate (per 1000 persons) of pre-specified infant adverse events for Exposed cohort infants-on or after 1st day of 27th week of pregnancy and Unexposed historical cohort infants Groups

Timeframe: From birth through 6 months of age

Secondary outcomes:

Incidence rate (per 1000 person-years) of other maternal adverse events for Exposed cohort women-on or after 1st day of 27th week of pregnancy and Unexposed historical cohort women Groups

Timeframe: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeks

Incidence rate (per 1000 persons) of other maternal adverse events for Exposed cohort women-on or after 1st day of 27th week of pregnancy and Unexposed historical cohort women Groups

Timeframe: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeks

Incidence rate (per 1000 persons) of other infant adverse events for Exposed cohort infants-on or after 1st day of 27th week of pregnancy and Unexposed historical cohort infants Groups

Timeframe: From birth through 6 months of age

Incidence rate (per 1000 person-years) of women adverse events for Exposed cohort women-before 1st day of 27th week of pregnancy Group

Timeframe: For the Exposed cohort women-before 1st day of 27th week of pregnancy: from date of Boostrix vaccination until end of enrollment or pregnancy, whichever came first, up to 40 weeks

Incidence rate (per 1000 persons) of women adverse events presented for Exposed cohort women-before 1st day of 27th week of pregnancy Group

Timeframe: For the Exposed cohort women-before 1st day of 27th week of pregnancy: from date of Boostrix vaccination until end of enrollment or pregnancy, whichever came first, up to 40 weeks

Incidence rate (per 1000 persons) of infant adverse events for Exposed cohort infants-before 1st day of 27th week of pregnancy Group

Timeframe: From birth through 6 months of age

Interventions:
  • Other: Safety assessment following routine immunization with Boostrix
    • Enrollment:
    65783
    Primary completion date:
    2020-04-08
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Whooping cough
    Product
    SB776423
    Collaborators
    Kaiser Permanente Southern California (KPSC)
    Study date(s)
    April 2018 to August 2020
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female
    Age
    Not applicable
    Accepts healthy volunteers
    Yes
    • 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.
    Inclusion and exclusion criteria
    Inclusion criteria:

      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 January 1, 2012-December 31, 2014 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).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Pasadena, California, United States, 91101
    Status
    Study Complete
    Contact us

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    2020-04-08
    Actual study completion date
    2020-04-08

    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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