Observational, Passive Surveillance Program to Collect Information on Women and Their Offs
Primary Objective: To assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi® during pregnancy or in the 30 days preceding their Last Menstrual Period (LMP).
| Condition(s) | Meningococcal Infection |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Primary Objective: To assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi® during pregnancy or in the 30 days preceding their Last Menstrual Period (LMP). |
| Who can participate | Inclusion Criteria: The eligible population will include pregnant women and their offspring residing in the US and its territories who are exposed to MenQuadfi® during their pregnancy or within 30 days prior to their LMP, for whom the exposure is reported to the pregnancy registry. Reports of MenQuadfi® pregnancy exposure must contain the following information: * Sufficient evidence to confirm that vaccination occurred during the pregnancy or in the 30 days preceding the LMP; * Vaccine name (brand or generic) is provided (i.e., MenQuadfi®, Meningococcal vaccine, MenACWY conjugate vaccine), or not specified (eg, meningococcal vaccine from an unknown manufacturer). Exclusion Criteria: Only post-marketing spontaneous case reports will be included; reports from clinical trials will not be part |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Sanofi Pasteur, a Sanofi Company |
| Locations | Swiftwater, Pennsylvania, United States |
| Start date | 2021-03-05 |
| NCT ID | NCT04843111 |
| Official listing | https://clinicaltrials.gov/study/NCT04843111 |