Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
Study of Outcomes in Pregnant Women Receiving Vaccine
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 outcomes for mothers and their babies when the mothers receive an investigational vaccine during pregnancy or just before becoming pregnant. The purpose is to observe any effects on both the mother and the baby, including during pregnancy and up to the baby's first year. The study will collect data from women who were vaccinated and track the health of their babies.
Participants will be asked to register their pregnancy and vaccination details before knowing the outcome of their pregnancy. This means they will provide information about when they received the vaccine and any health events during pregnancy. The study will follow the mothers until they give birth and will monitor their babies until they are one year old.
- Who can participate: Pregnant women residing in the US or its territories who received the vaccine during pregnancy or within 30 days before their last menstrual period can participate. Only post-marketing spontaneous case reports are included, and reports from clinical trials are excluded. The vaccine exposure must be reported to the registry with sufficient evidence confirming the timing of vaccination.
- Study details: Participants will need to register their pregnancy and vaccination details before knowing the pregnancy outcome. They will provide information about the vaccine timing and any health events during pregnancy. Only post-marketing spontaneous case reports will be part of the registry. The study will monitor mothers until childbirth and follow the babies until they are one year old.
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