Fluarix®/ FluLaval®/ Fluarix® Quadrivalent/ FluLaval® Quadrivalent Vaccine Pregnancy Registry

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.

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.