Last updated: 01/28/2022 08:10:06

Boostrix® Pregnancy Registry

GSK study ID
201327
See study documents
Clinicaltrials.gov ID
NCT02096276
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: Boostrix Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with Boostrix® during pregnancy or within 28 days preceding conception
Trial description: The purpose of this Registry is to detect and describe any abnormal pregnancy outcomes, including teratogenicity, in females intentionally or unintentionally exposed to Boostrix during their pregnancies in the US. The Registry requires voluntary, prospective reporting of eligible pregnancies by patients and health care providers (HCPs). Data such as vaccination with Boostrix during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy will be collected prospectively
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with known pregnancy outcomes, by type of pregnancy outcomes in women intentionally or unintentionally vaccinated with Boostrix during pregnancy or within 28 days preceding conception.

Timeframe: Data collected between 03 May 2005 to 02 August 2019: For each subject from date of registration until the pregnancy outcome documentation date (Exposure_Prospective group) or at pregnancy outcome documentation date (Exposure_Retrospective group)

Secondary outcomes:
Not applicable
Interventions:
  • Other: Data collection
    • Enrollment:
    1517
    Primary completion date:
    2019-02-08
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Anastasia Kuznetsova, Maria Angeles Ceregido, Anne Jourquin, Laura Campora, Fernanda Tavares da Silva . Fourteen years of the Pregnancy Registry on maternal immunisation with a reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap) vaccine. Vaccine. 2022;ePublished: DOI: http://dx.doi.org/ https://doi.org/10.1016/j.vaccine.2021.12.050
    Medical condition
    Pertussis
    Product
    GSK2647153A, SB263855, SB776423
    Collaborators
    Not applicable
    Study date(s)
    March 2014 to August 2019
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female
    Age
    12 - 64 years
    Accepts healthy volunteers
    Yes
    • A subject will be included in the Registry if all of the following criteria are met:
    • Exposure to vaccine occurs during pregnancy or within 28 days preceding conception.
    • Data from registered subjects will not be included in the analyses if the following criterion is met:
    • Outcome of pregnancy is known at the time of initial report. Types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus. Typically, pregnancies > 16 weeks gestation will have undergone prenatal testing that can identify whether a child has congenital abnormalities.
    Inclusion and exclusion criteria
    Inclusion criteria:

      A subject will be included in the Registry if all of the following criteria are met:

      • Exposure to vaccine occurs during pregnancy or within 28 days preceding conception.
      • Subject is a US resident.
      • A HCP is identified (name, address and phone number).
      • Subject can be identified (by GSK or HCP). Data from registered subjects will be included in the analyses if the following criterion is met:
      • Pregnancy is ongoing and the outcome is unknown.
    Exclusion criteria:

      Data from registered subjects will not be included in the analyses if the following criterion is met:

      • Outcome of pregnancy is known at the time of initial report. Types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus. Typically, pregnancies > 16 weeks gestation will have undergone prenatal testing that can identify whether a child has congenital abnormalities.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Research Triangle Park, North Carolina, United States, 27709-3398
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol and 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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2019-02-08
    Actual study completion date
    2019-02-08

    Plain language summaries

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

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website