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Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
Sponsor: Sanofi Pasteur, a Sanofi Company
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).
Official title: The MenQuadfi® Pregnancy Registry: A Surveillance Registry to Assess the Safety of MenQuadfi® Among Exposed Pregnant Women and Their Offspring
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2021-03-05
Completion Date
2028-05-18
Last Updated
2025-12-01
Healthy Volunteers
Yes
Conditions
Interventions
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular
Locations (1)
Pennsylvania Locations
Swiftwater, Pennsylvania, United States