Cresco

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.

Researchers are conducting an observational study to understand treatment outcomes in people diagnosed with chronic inflammatory demyelinating polyneuropathy/polyradiculoneuropathy (CIDP) in the United States. This study focuses on individuals who have residual impairment, disability, or neurological deficits after at least three months of treatment with standard therapies. The study is descriptive and non-interventional, aiming to gather real-world information on disease impact and treatment effects over time. Participants will be observed for up to two years, with enrollment continuing for one year. Depending on when they join, participants may be followed for between one and two years. The study collects digital biomarker data and tracks integrated treatment outcomes without altering participants' ongoing care. There are no study treatments or interventions administered as part of this research. During the study, participants will have their condition assessed using various scales such as the I-RODS and adjusted INCAT scores, to measure disability and response to treatment. Researchers will monitor changes in these scores over time, including after any treatment changes. Additional assessments include recording the incidence and frequency of comorbidities, laboratory tests, and remote neurological evaluations. All data are collected to better understand disease progression and treatment outcomes in real-world settings.