Safety Registry for Pregnant Women and Their Babies Exposed to MenQuadfi Vaccine in the United States

What this Trial Is About

Researchers are observing maternal, obstetrical, pregnancy, neonatal, and infant outcomes in women who receive the MenQuadfi4 vaccine during pregnancy or within 30 days before their last menstrual period. This prospective pregnancy registry aims to collect and analyze information on pregnancies exposed to MenQuadfi4, focusing on safety outcomes for both mothers and their offspring. The study is sponsored by Sanofi Pasteur and follows women and their infants in the United States and its territories. Pregnant women who have received the MenQuadfi4 vaccine during pregnancy or shortly before within 30 days prior to their last menstrual period are registered in this observational registry. These women and their offspring are followed throughout the pregnancy and until the child reaches one year of age. The vaccine involved is a meningococcal polysaccharide tetanus toxoid conjugate vaccine administered as an intramuscular injection. Participants will be monitored for maternal adverse events from vaccination through up to 22 months post-entry, obstetrical adverse events from vaccination until 28 days after delivery, and pregnancy adverse events on the day of birth. Neonatal adverse events will be tracked from birth to 28 days after birth, and infant adverse events from 29 days to one year of age. This registry collects detailed information to help understand vaccine exposure safety during pregnancy and early infancy.

Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)