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

Observation of Pregnancy Outcomes in Women Exposed to MenQuadfi®

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.

Updated on 21 Aug 2023. Study ID: NCT04843111

This study investigates the effects of an investigational vaccine on maternal, obstetrical, pregnancy, and neonatal outcomes. It focuses on women vaccinated with the investigational vaccine during pregnancy or within 30 days before their last menstrual period (LMP). An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment, which may focus on people using specific medications or having certain conditions to better understand how treatments work.

Participants will be encouraged to register before knowing the pregnancy outcome. Pregnant women will be monitored until the end of their pregnancy, and their children will be followed up to one year of age. This study will help gather data on the safety and effects of the investigational vaccine during pregnancy.

  • Who can participate: Pregnant women residing in the US and its territories who were exposed to the investigational vaccine during pregnancy or within 30 days prior to their last menstrual period can participate. Participants must have their exposure reported to the pregnancy registry.
  • Study details: Participants will be observed without altering their treatment to collect data on pregnancy and neonatal outcomes. The study will focus on those who have received MenQuadfi® during pregnancy.

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