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

Research Study on Vaccination During Pregnancy and Infant Outcomes

Recruiting
All
Phase N/A
50 participants needed
2 Locations

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 04 Nov 2024. Study ID: NCT04843111

This study investigates the effects of receiving an investigational vaccine during pregnancy or shortly before. The focus is on understanding how this vaccination might affect mothers and their babies, both during pregnancy and after birth.

Participants in the study will be monitored throughout the pregnancy and the first year of the child's life. This includes collecting information on health outcomes for both the mother and the baby.

  • Who can participate: Pregnant women in the US and its territories who received the investigational vaccine during pregnancy or within 30 days before their last menstrual period can participate. Vaccine exposure must be reported to the pregnancy registry.
  • Study details: Participants will be part of a registry that tracks health outcomes. The registry collects information to ensure unbiased data collection.

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