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

Recruitingn/aAges any - anyAllSanofi Pasteur, a Sanofi Company
NCT04843111 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

  • Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
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Where

1 site
Pennsylvania Locations
Swiftwater, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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