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

Recruiting now

Conditions studied: Meningococcal Infection

In brief

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).

Key facts

Study ID

NCT04843111

Run by

Sanofi Pasteur, a Sanofi Company

People needed

50

Starts

2021-03-05

Expected to finish

2028-05-18

Last updated by the study team

2025-12-01

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Pennsylvania Locations — Swiftwater, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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