Last updated: 11/03/2018 16:19:37

Post-marketing study to assess the safety of CERVARIX when used in the United States and in Canada

GSK study ID
114176
See study documents
Clinicaltrials.gov ID
NCT01290393
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
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 abortion following administration of CERVARIX in the United States and Canada
Trial description: This study will assess the risk of spontaneous abortion during weeks 1-19 of gestation, and other pregnancy outcomes, in an Exposed vaccinated cohort, i.e. women with last menstrual period between 30 days before and 90 days after any dose of CERVARIX, when compared to a Non-exposed vaccinated cohort, i.e. women with last menstrual period between 120 days and 18 months after the last CERVARIX or GARDASIL dose.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of spontaneous abortion during weeks 1-19 of gestation

Timeframe: This outcome measure will be recorded between zero and six weeks after end of pregnancy

Secondary outcomes:

Occurrence of other adverse pregnancy outcomes

Timeframe: This outcome measure will be recorded between zero and six weeks after end of pregnancy

Interventions:
  • Other: Data collection
    • Enrollment:
    2
    Primary completion date:
    2012-20-12
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Papillomavirus
    Product
    SB580299
    Collaborators
    Organization of Teratology Information Specialists (OTIS)
    Study date(s)
    September 2011 to December 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    15 - 25 years
    Accepts healthy volunteers
    Yes
    • For Exposed vaccinated cohort:
    • Written informed consent, and assent in case of minors, obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
    • For Exposed vaccinated cohort:
    • Last menstrual period between 30 days before and 90 days after any GARDASIL dose.
    Inclusion and exclusion criteria
    Inclusion criteria:

      For Exposed vaccinated cohort:

      • Written informed consent, and assent in case of minors, obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
      • Aged between, and including, 15 and 25 years of age.
      • Residing within the US or Canada.
      • Subjects who received at least one dose of CERVARIX.
      • Gestational age at inclusion should be 19 completed weeks (i.e. 133 days of gestation) or less.
      • Last menstrual period between 30 days before and 90 days after any dose of CERVARIX with a maximum of 20% of subjects with last menstrual period between 46 and 90 days after any dose of CERVARIX.
      • Subjects who the Investigator believes can and will comply with the requirements of the protocol (e.g. available for phone interviews). Or subjects who the Investigator believes that parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol. For Non-exposed vaccinated cohort:
      • Written informed consent, and assent in case of minors, obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
      • Aged between, and including, 15 and 25 years of age.
      • Residing within the US or Canada.
      • Subjects who received at least one dose of CERVARIX or at least one dose of GARDASIL.
      • Gestational age at inclusion should be 19 completed weeks (i.e. 133 days of gestation) or less.
      • Last menstrual period between 120 days and 18 months after the last dose of CERVARIX/ GARDASIL.
      • Subjects who the Investigator believes can and will comply with the requirements of the protocol (e.g. available for phone interviews). Or subjects who the Investigator believes that parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol.
    Exclusion criteria:

      For Exposed vaccinated cohort:

      • Last menstrual period between 30 days before and 90 days after any GARDASIL dose.
      • Ongoing pregnancy with foetus known to be non-viable.
      • Ongoing pregnancy with pre-enrolment knowledge by prenatal diagnosis of a major structural defect.
      • Use of any investigational or non-registered product (drug or vaccine) during the study period. For Non-exposed vaccinated cohort:
      • Ongoing pregnancy with foetus known to be non-viable.
      • Ongoing pregnancy with pre-enrolment knowledge by prenatal diagnosis of a major structural defect.
      • Use of any investigational or non-registered product (drug or vaccine) during the study period.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    San Diego, California, United States, 92123
    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
    Other
    Actual primary completion date
    2012-20-12
    Actual study completion date
    2012-20-12

    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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