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 with Vaccine Exposure
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
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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 an investigational vaccine on pregnancy and infant outcomes. The purpose is to understand how the vaccine affects mothers and their babies when given during pregnancy or shortly before conception. The study will collect data from women who received the vaccine and track their health and the health of their babies.
Participants will be followed throughout their pregnancy, and their babies will be monitored until they are one year old. This involves collecting information about the health of both the mother and the child to see if there are any effects from the vaccine. The study aims to gather detailed information to better understand these outcomes.
- 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, provided the exposure is reported to the pregnancy registry.
- Study Details: Participants will be monitored during their pregnancy and their babies will be followed until one year of age. The study will collect health information to understand the effects of the vaccine.
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