Last updated: 02/21/2024 12:30:35

Post-marketing safety study to assess the risk of spontaneous abortions in women exposed to Cervarix residing in UK

GSK study ID
114101
See study documents
Clinicaltrials.gov ID
NCT01905462
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: Post-marketing safety study to assess the risk of spontaneous abortions in women exposed to Cervarix in the United Kingdom
Trial description: This study will assess the risk of spontaneous abortion during weeks 1-23 and weeks 1-19 of gestation, respectively, and other pregnancy outcomes, in an exposed cohort, i.e. women with last menstrual period (LMP) between 30 days before and 45 days after, or 30 days before and 90 days after any dose of Cervarix, when compared to a non-exposed cohort, i.e. women with LMP between 120 days and 18 months after the last Cervarix dose. The data collected in the Clinical Practice Research Datalink General Practitioner OnLine Database (CPRD GOLD) in the UK, will be analysed in this study.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of spontaneous abortion

Timeframe: Weeks 1-23 of gestation

Secondary outcomes:

Occurrence of spontaneous abortion

Timeframe: Weeks 1-19 of gestation

Occurrence of other pregnancy outcomes

Timeframe: 12 months after last menstrual period

Baby’s death

Timeframe: First 12 weeks of baby’s life

Interventions:
  • Other: Data Collection
  • Biological/vaccine: Cervarix
    • Enrollment:
    1046
    Primary completion date:
    2013-06-08
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Papillomavirus
    Product
    SB580299
    Collaborators
    Clinical Practice Research Datalink General Practitioner OnLine Database
    Study date(s)
    November 2012 to August 2013
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female
    Age
    15 - 25 years
    Accepts healthy volunteers
    Yes
    • For the exposed cohort:
    • All subjects must satisfy all of the following criteria at entry into the exposed cohort:
    • For the exposed cohort:
    • Female with the first day LMP between 30 days before and 90 days after at least one dose of unspecified Human Papillomavirus vaccine and/or Gardasil.
    Inclusion and exclusion criteria
    Inclusion criteria:

      For the exposed cohort: All subjects must satisfy all of the following criteria at entry into the exposed cohort:

      • Full date of first day of LMP available in the database or calculated from Estimated date of delivery (EDD).
      • Female, aged between, and including, 15 and 25 years of age at LMP.
      • Recorded in the CPRD GOLD for at least 12 months at LMP.
      • First day of LMP available in the database or calculated from EDD between September 1st 2008 and June 30th 2011.
      • At least one dose of Cervarix received between September 1st 2008 and June 30th 2011.
      • Full date of Cervarix vaccination(s) available.
      • First day of LMP available in the database or calculated from EDD between 30 days before and 90 days after any dose of Cervarix.
      • Subject defined as acceptable in CPRD GOLD. For the non-exposed cohort: All subjects must satisfy all of the following criteria at entry into the non-exposed cohort:
      • Full date of first day of LMP available in the database or calculated from EDD.
      • Female, aged between, and including, 15 and 25 years of age at LMP.
      • Recorded in the CPRD GOLD since at least 12 months at LMP.
      • First day of LMP available in the database or calculated from EDD between September 1st 2008 and June 30th 2011.
      • At least one dose of Cervarix received between September 1st 2008 and June 30th 2011.
      • Full date of Cervarix vaccination(s) available.
      • First day of LMP available in the database or calculated from EDD between 120 days and 18 months after the last dose of Cervarix.
      • Subject defined as acceptable in CPRD GOLD.
    Exclusion criteria:

      For the exposed cohort:

      • Female with the first day LMP between 30 days before and 90 days after at least one dose of unspecified Human Papillomavirus vaccine and/or Gardasil. For the non-exposed cohort:
      • Female with the first day LMP between 30 days before and 90 days after at least one dose of unspecified Human Papillomavirus vaccine and/or Gardasil.
      • Female included for a previous pregnancy in the exposed cohort.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, SW1W 9SZ
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    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
    2013-06-08
    Actual study completion date
    2013-06-08

    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