Status:
RECRUITING
Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Meningococcal Infection
Eligibility:
All Genders
Brief 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 Menstrua...
Detailed Description
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 prospecti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 18 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04843111
Start Date
March 5 2021
End Date
May 18 2028
Last Update
December 1 2025
Active Locations (1)
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1
Pennsylvania Locations
Swiftwater, Pennsylvania, United States, 18370-0187