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

Research Study on Maternal and Infant Outcomes After Exposure to Investigational Vaccine During Pregnancy

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 effects of exposure to an investigational vaccine during pregnancy. The purpose is to assess maternal, obstetrical, pregnancy, neonatal, and infant outcomes among women who were vaccinated with the investigational vaccine during pregnancy or in the 30 days before their last menstrual period.

Participants in this observational study will be followed through the end of their pregnancy, and their offspring will be monitored up to one year of age. The study is a prospective pregnancy registry, meaning that pregnancies are registered before the outcome is known, allowing for more accurate data collection on the effects of the investigational vaccine.

  • Who can participate: Pregnant women and their offspring in the US who were exposed to the investigational vaccine during pregnancy or within 30 days before their last menstrual period are eligible. Reports must confirm the timing of vaccination and include the vaccine name or type.
  • Study details: Participants will be observed throughout their pregnancy, and their children will be followed until they reach one year of age.
Updated on 01 Dec 2025. Study ID: NCT04843111

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