Post-Licensure Database Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Enrollment
- 96175
- Locations
- 1
- Primary Endpoint
- Incidence Rates of Pregnancy Outcome Events
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence Rates of Pregnancy Outcome Events
Time Frame: From start of pregnancy or up to 28 days prior to conception until delivery or pregnancy outcome
Pregnancy outcome events: spontaneous abortion, preterm labor, stillbirth/Fetal death, congenital/fetal anomalies detected during pregnancy, eclampsia, and placental abruption
Incidence Rates of Birth Events
Time Frame: At birth
Preterm birth, low birth weight or small for gestational age observed or diagnosed at birth
Incidence Rates of Neonatal/ Infant Outcomes
Time Frame: From birth to Day 365 post-birth
Neonatal/ infant outcomes: infant death, any congenital anomalies detected after delivery, and failure to thrive