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

Study of Pregnancy and Infant Outcomes After Meningococcal Vaccination

Recruiting
All
Phase N/A
50 participants needed
1 Location

Study Overview

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).

Study Details

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Meningococcal Infection
  • Gender: All

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 of the registry.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

The purpose of this research study is to collect information about pregnancy and baby outcomes in women in the United States who received a meningococcal vaccine during pregnancy or within 30 days before their last menstrual period.

Participants will join a pregnancy registry (a program that collects health information over time). The study team will collect and review information about the mother’s health and pregnancy, and about the baby’s health after birth.

Who can participate:
Pregnant women in the United States (and its territories) may be able to participate if they:

  • Live in the US or a US territory
  • Have been exposed to a meningococcal vaccine during pregnancy or within 30 days before their last menstrual period
  • Have this vaccine exposure reported to the pregnancy registry with enough information to confirm when the vaccination happened and what vaccine it was (or that it was a meningococcal vaccine from an unknown manufacturer)

Study timeline and visits:
Participation lasts through the end of the pregnancy, and the child will be followed for up to 1 year of age.

Updated on 27 Nov 2025. Study ID: NCT04843111

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