An observational study in Meningococcal Infection, sponsored by Sanofi Pasteur, a Sanofi Company. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-12-01.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Observational
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).
This study is a prospective pregnancy registry to collect and analyze the outcome of exposure to MenQuadfi™ during pregnancy or within 30 days prior to their LMP. The registry will encourage prospective registration, which is defined as registration of a pregnancy exposure prior to knowledge or perceived knowledge of the pregnancy outcome.
Exposed pregnant women will be followed up to the end of their pregnancy, and the offspring(s) will be followed up to 1 year of age.
243 studies on the registry are indexed under Meningococcal Infections; 8 are open to participants now.
This study's planned enrollment of 50 is below the median of 116 across 27 observational studies indexed under Meningococcal Infections.
Browse Meningococcal Infections studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
First submitted after Sanofi Pasteur became part of Sanofi.
Counted across the registry records on this site, refreshed daily.
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 last menstrual period (LMP), for whom the exposure is reported to the pregnancy registry.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Only post-marketing spontaneous case reports will be included; reports from clinical trials will not be part of the registry.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Pregnant women and their offspring(s) exposed to MenQuadfi® during their pregnancy or within 30 days prior to their LMP
Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular
Also known as: Meningococcal A-C-Y-W135 (T CONJ) vaccine
Percentage of pregnant women with maternal adverse events (AEs)
Maternal adverse events defined as any reported adverse event (AE), following vaccination of a pregnant woman, occurring independent of the pregnancy (e.g., injection site reactions)
Time frame: From vaccination to end of follow-up (i.e.,up to 22 months after cohort entry)
Percentage of pregnant women with obstetrical AEs
Obstetrical adverse events defined as any reported AE, following vaccination of a pregnant woman, related directly to the pregnancy (e.g., complications of pregnancy, labor and delivery, and puerperium)
Time frame: From vaccination to 28 days after delivery
Percentage of pregnant women with pregnancy AEs
Pregnancy adverse events defined as any reported AE, following vaccination of a pregnant woman, related to birth outcomes (e.g., live birth, spontaneous abortion/miscarriage, stillbirth/fetal death)
Time frame: On day of birth
Percentage of offsprings with adverse neonatal AEs
Neonatal events defined as any reported AE, following vaccination of a pregnant woman, directly related to the infant and assessed immediately after birth or within the first 28 days of life (e.g., congenital anomalies)
Time frame: From day of birth to 28 days post-birth
Percentage of offsprings with adverse infant AEs
Infant events defined as any reported AE, following vaccination of a pregnant woman, directly related to the infant occurring / diagnosed between days 29 and 365 post-birth
Time frame: From day 29 post-birth to 365 days post-birth
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
No publications or documents are linked to this record.
Started Mar 2021 (actual). Primary completion is estimated for May 2028, 86 months after the start.
How these figures are worked out, and which studies are left out of them.
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Sanofi Pasteur, a Sanofi Company →