Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring

Study Overview
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Brief Summary
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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:

Detailed Description
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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.

Official Title
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Post-Licensure Database Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring

Conditions
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Influenza

Intervention / Treatment
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* Biological: Flublok Quadrivalent influenza vaccine RIV4
* Biological: Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Pregnant women from the VAP00003 Study and their offspring - Pregnant women from the VAP00003 Study (NCT03694392) between September 2018 and May 2020 (2 influenza seasons), and infants born from this cohort of pregnant women | Biological: Flublok Quadrivalent influenza vaccine RIV4<br>* Route of administration: Intramuscular<br>* Other names: RIV4;Biological: Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4<br>* Route of administration: Intramuscular<br>* Other names: SD-IIV4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rates of Pregnancy Outcome Events | Pregnancy outcome events: spontaneous abortion, preterm labor, stillbirth/Fetal death, congenital/fetal anomalies detected during pregnancy, eclampsia, and placental abruption | From start of pregnancy or up to 28 days prior to conception until delivery or pregnancy outcome | 
| Incidence Rates of Birth Events | Preterm birth, low birth weight or small for gestational age observed or diagnosed at birth | At birth | 
| Incidence Rates of Neonatal/ Infant Outcomes | Neonatal/ infant outcomes: infant death, any congenital anomalies detected after delivery, and failure to thrive | From birth to Day 365 post-birth |