Clinical trial NCT02148211: Fluarix/ FluLaval/ Fluarix Quadrivalent/ FluLaval Quadrivalent Vaccine Pregnancy Registry
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: Fluarix Quadrivalent
Fluarix
FluLaval
FluLaval Quadrivalent
Pregnancy Registry
Pregnancy outcome
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-05-28
Enrollment: 507
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women, residing in the US, vaccinated with any of the 4 GSK sIIVs during pregnancy or within 28 days preceding conception and who are volunteering to take part in the Pregnancy Registry before the outcome of the pregnancy is known.

Brief summary: 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.

Detailed description: This study is a transition of existing ongoing pregnancy registries for Fluarix/ FluLaval/Fluarix Quadrivalent/ FluLaval Quadrivalent into one post-authorization safety study (PASS).

Pregnancy outcome data will be collected using questionnaires within 2 months of the estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD (for all live births) to ascertain the presence of birth defects not diagnosed before, from Q2 2014 to Q2 2019.

The intent of the Registry is to prospectively collect data such as vaccination with GSK sIIVs 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.

Eligibility 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.

Primary outcomes:
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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
measure: 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:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Nwoji U. Seasonal influenza vaccine exposure in pregnancy: 5-year results from a pregnancy registry. Hum Vaccin Immunother. 2022 Dec 31;18(1):1932213. doi: 10.1080/21645515.2021.1932213. Epub 2021 Jun 3.