Last updated: 11/03/2018 21:14:24

FluLaval® Quadrivalent Pregnancy Registry

GSK study ID
201086
Clinicaltrials.gov ID
NCT02000466
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: FluLaval® Quadrivalent Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with FluLaval® Quadrivalent during pregnancy or within 28 days preceding conception
Trial description: The purpose of this pregnancy registry study is to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with FluLaval Quadrivalent. The Registry requires voluntary, prospective reporting of eligible pregnancies by patients and health care providers (HCPs). Data such as vaccination with FluLaval Quadrivalent 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:

Occurrence of any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with FluLaval Quadrivalent during pregnancy or within 28 days preceding conception

Timeframe: Up to 12 months after EDD

Secondary outcomes:
Not applicable
Interventions:
  • Other: Data collection
    • Enrollment:
    0
    Primary completion date:
    2014-01-06
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Influenza
    Product
    GSK2647158A
    Collaborators
    Not applicable
    Study date(s)
    November 2013 to June 2014
    Type
    Observational
    Phase
    Not applicable

    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. Pregnancies in which prenatal testing indicates a normal pregnancy would also be excluded because inclusion of such pregnancies could potentially bias results toward a lower overall estimate of risk for defects. 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. Pregnancies in which prenatal testing indicates a normal pregnancy would also be excluded because inclusion of such pregnancies could potentially bias results toward a lower overall estimate of risk for defects. Typically pregnancies > 16 weeks gestation will have undergone prenatal testing that can identify whether a child has congenital abnormalities.

    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
    Other
    Actual primary completion date
    2014-01-06
    Actual study completion date
    2014-01-06

    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