Last updated: 06/30/2021 07:40:07

Fluarix/ FluLaval/ Fluarix Quadrivalent/ FluLaval Quadrivalent vaccine Pregnancy Registry

GSK study ID
201476
See study documents
Clinicaltrials.gov ID
NCT02148211
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: Fluarix/ FluLaval/ Fluarix Quadrivalent/ FluLaval Quadrivalent Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with Fluarix or Fluarix Quadrivalent or FluLaval or FluLaval Quadrivalent during pregnancy or within 28 days preceding conception.
Trial description: The purpose of this pregnancy registry study is to detect and describe abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with any of GlaxoSmithKline (GSK) Biologicals’ seasonal Inactivated Influenza Vaccines (sIIVs): Fluarix, FluLaval, Fluarix Quadrivalent and FluLaval Quadrivalent.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of subjects reported with exposure and outcomes, stratified by trimester of exposure, in pregnant women intentionally or unintentionally vaccinated with FluLaval during pregnancy or within 28 days preceding conception

Timeframe: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births)

Number of subjects reported with exposure and outcomes, stratified by trimester of exposure in pregnant women intentionally or unintentionally vaccinated with FluLaval Quadrivalent during pregnancy or within 28 days preceding conception

Timeframe: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births)

Number of subjects reported with exposure and outcomes, stratified by trimester of exposure in pregnant women intentionally or unintentionally vaccinated with Fluarix during pregnancy or within 28 days preceding conception

Timeframe: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births)

Number of subjects reported with exposure and outcomes stratified by trimester of exposure in pregnant women intentionally or unintentionally vaccinated with Fluarix Quadrivalent during pregnancy or within 28 days preceding conception

Timeframe: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births)

Number of subjects reported with unsolicited adverse events (AEs)

Timeframe: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019

Number of subjects reported with Serious Adverse Events (SAEs)

Timeframe: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019

Secondary outcomes:
Not applicable
Interventions:
  • Other: Data collection
    • Enrollment:
    507
    Primary completion date:
    2019-31-05
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Nwoji U. Seasonal influenza vaccine exposure in pregnancy: 5-year results from a pregnancy registry. Hum Vaccin Immunother. 1-6. doi: 10.1080/21645515.2021.1932213.
    Medical condition
    Influenza
    Product
    GSK2647158A
    Collaborators
    Not applicable
    Study date(s)
    June 2014 to May 2019
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female
    Age
    Not applicable
    Accepts healthy volunteers
    Yes
    • A subject will be included in the Registry if all of the following criteria are met:
    • Exposure to GSK sIIVs 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.
    Inclusion and exclusion criteria
    Inclusion criteria:

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

      • Exposure to GSK sIIVs 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 at the time of initial report.
    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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Wilmington, North Carolina, United States, 284013331
    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
    2019-31-05
    Actual study completion date
    2019-31-05

    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