Primary Objective:

To evaluate the safety of Flublok Quadrivalent influenza vaccine in pregnant women included in the VAP00003 Study (NCT03694392) and their offspring exposed during pregnancy or up to 28 days preceding the estimated date of conception with regards to pregnancy, birth, and neonatal/infant outcomes

Secondary Objective:

Data will be recorded prospectively during the safety follow-up for pregnant women until delivery (or pregnancy outcome, whichever is later), and for infants of pregnant women for 1 year after birth.

Inclusion criteria

Pregnant women:

• Laboratory or medical professional confirmation of pregnancy
• Exposure to either Flublok Quadrivalent influenza vaccine or standard-dose quadrivalent inactivated influenza vaccine (SD-IIV4) in the VAP00003 Study during pregnancy or within 28 days preceding conception

Offspring:

• Infants delivered by pregnant women who satisfy the criteria above Exclusion criteria
• Documented receipt of any other influenza vaccine at any other time during the pregnancy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Women were not randomized. A modified-cluster randomization scheme was used. Facilities were assigned to blocks and were randomized within blocks, ensuring that roughly half the facilities within each block initially administer one vaccine of the 2 vaccines planned in the study, and the other half administer the alternate vaccine. Iteratively, over time, the vaccine administered within each facility will then alternate.

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org