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.

This observational study focuses on people in the United States diagnosed with chronic inflammatory demyelinating polyneuropathy or polyradiculoneuropathy CIDP who still have impairments, disabilities, or neurological deficits after at least three months of standard care treatment. The study aims to collect real-world data on treatment outcomes and disease progression over time, lasting approximately two years. Enrollment will continue for one year, so participants may be followed for one to two years depending on when they join. Participants in this study do not receive any experimental treatments instead, their ongoing use of standard CIDP therapies such as immunoglobulin, corticosteroids with some exceptions, plasma exchange, and other specified medications are observed. The study involves digital biomarker collection and integrated treatment outcome monitoring to understand changes in disability and neurological function over the study period. During the study, participants will have their disability and neurological status assessed using tools like the I-RODS and adjusted INCAT scores at baseline and throughout the follow-up. Researchers will collect laboratory tests, comorbidity data, and responses to treatment changes as they occur. Follow-up will continue up to two years from the start of the study, with data collected remotely and through medical records to evaluate disease progression and treatment response.