Actively Recruiting

All Genders
Healthy Volunteers
NCT04843111

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

Led by Sanofi Pasteur, a Sanofi Company · Updated on 2025-12-01

50

Participants Needed

1

Research Sites

375 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women and their offspring residing in the US or its territories
  • Exposure to MenQuadfi4 vaccine during pregnancy or within 30 days before last menstrual period
  • Sufficient evidence confirming vaccination timing during pregnancy or within 30 days before last menstrual period
  • Vaccine name provided or identified as a meningococcal vaccine from an unknown manufacturer
  • Exposure reported to the pregnancy registry
Not Eligible

You will not qualify if you...

  • Reports from clinical trials are excluded; only post-marketing spontaneous case reports are included

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Pennsylvania Locations

Swiftwater, Pennsylvania, United States, 18370-0187

Actively Recruiting

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Research Team

T

Trial Transparency email recommended (Toll free number for US & Canada)

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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