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

Study on Pregnancy Outcomes After Exposure to Investigational Medication

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.

This study investigates the outcomes of pregnancy in women exposed to a specific condition. The purpose of this study is to collect information on the effects of this exposure during pregnancy.

The focus of the study is to evaluate the safety of exposure to the investigational vaccine during pregnancy. It looks at outcomes related to maternal health, pregnancy, and infant health.

  • Who can participate: Pregnant women and their children living in the US who were exposed to the investigational vaccine during pregnancy or within 30 days before their last menstrual period can participate. The exposure must be reported to the pregnancy registry.
  • Study details: Participants will be followed until the end of their pregnancy, and their children will be monitored up to one year of age. This study is observational and does not involve any treatment or placebo.
Updated on 27 Nov 2025. Study ID: NCT04843111

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