Overview

This trial is active, not recruiting.

Condition influenza
Treatment data collection
Sponsor GlaxoSmithKline
Start date June 2014
End date June 2019
Trial size 1800 participants
Trial identifier NCT02148211, 201476

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Pregnant women, residing in the US and vaccinated with any of the 4 GSK seasonal Inactivated Influenza Vaccines (sIIVs) during pregnancy or within 28 days preceding conception.
data collection
Initial and follow-up data will be collected using questionnaires.

Primary Outcomes

Measure
Occurrence of abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with Fluarix or FluLaval or Fluarix Quadrivalent or FluLaval Quadrivalent during pregnancy or within 28 days preceding conception.
time frame: Within 3 months of and up to 12 months after the estimated date of delivery (EDD).

Eligibility Criteria

Female participants of any age.

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. 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.

Additional Information

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.
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 3 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.