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
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2019-31-05
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
Finalized
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
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