NCT04843111

Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)

The MenQuadfi® Pregnancy Registry: A Surveillance Registry to Assess the Safety of MenQuadfi® Among Exposed Pregnant Women and Their Offspring

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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).

Detailed description

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.

Conditions

• Meningococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine	Pharmaceutical form: Solution for injection Route of administration: Intramuscular

Timeline

• Start date: 2021-03-05
• Primary completion: 2028-05-18
• Completion: 2028-05-18
• First posted: 2021-04-13
• Last updated: 2025-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study