Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring
- Conditions
- Influenza
- Registration Number
- NCT04460781
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96175
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence Rates of Pregnancy Outcome Events 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 At birth Preterm birth, low birth weight or small for gestational age observed or diagnosed at birth
Incidence Rates of Neonatal/ Infant Outcomes From birth to Day 365 post-birth Neonatal/ infant outcomes: infant death, any congenital anomalies detected after delivery, and failure to thrive
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kaiser Permanente Northern California
🇺🇸Oakland, California, United States
Kaiser Permanente Northern California🇺🇸Oakland, California, United States