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

NCT04843111 · tracked via the Priya Life Science USA tracker

Sponsor

Sanofi Pasteur, a Sanofi Company

Phase

Observational

Started

2021-03-05

Last updated

2025-12-01

Condition(s) studied

Meningococcal Infection

Investigational drug(s) / intervention(s)

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

Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine: Pharmaceutical form: Solution for injection Route of administration: Intramuscular

Study summary

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).

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Percentage of pregnant women with maternal adverse events (AEs) — From vaccination to end of follow-up (i.e.,up to 22 months after cohort entry)
Maternal adverse events defined as any reported adverse event (AE), following vaccination of a pregnant woman, occurring independent of the pregnancy (e.g., injection site reactions)
Percentage of pregnant women with obstetrical AEs — From vaccination to 28 days after delivery
Obstetrical adverse events defined as any reported AE, following vaccination of a pregnant woman, related directly to the pregnancy (e.g., complications of pregnancy, labor and delivery, and puerperium)
Percentage of pregnant women with pregnancy AEs — On day of birth
Pregnancy adverse events defined as any reported AE, following vaccination of a pregnant woman, related to birth outcomes (e.g., live birth, spontaneous abortion/miscarriage, stillbirth/fetal death)

Trial sites (1)

Facility	City	Region	Status
Pennsylvania Locations	Swiftwater	Pennsylvania	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04843111 on ClinicalTrials.gov ↗ ← All trials in the USA