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

Sanofi Pasteur, a Sanofi Company96,175 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

96,175

Conditions

Influenza

Interventions

Flublok Quadrivalent influenza vaccine RIV4BIOLOGICAL

Route of administration: Intramuscular

Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4BIOLOGICAL

Route of administration: Intramuscular

Eligibility

Sex: ALLMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Kaiser Permanente Northern California

Oakland, California, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: At birth

Incidence Rates of Neonatal/ Infant Outcomes

Neonatal/ infant outcomes: infant death, any congenital anomalies detected after delivery, and failure to thrive

Time frame: From birth to Day 365 post-birth

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.