Clinical trial
The MenQuadfi® Pregnancy Registry: A Surveillance Registry to Assess the Safety of MenQuadfi® Among Exposed Pregnant Women and Their Offspring
Name
MEQ00070
Description
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).
Trial arms
Trial start
2021-03-05
Estimated PCD
2028-05-18
Trial end
2028-05-18
Status
Recruiting
Treatment
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular
Arms:
Pregnant women and their offspring(s)
Other names:
Meningococcal A-C-Y-W135 (T CONJ) vaccine
Size
50
Primary endpoint
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)
Percentage of pregnant women with obstetrical AEs
From vaccination to 28 days after delivery
Percentage of pregnant women with pregnancy AEs
On day of birth
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '22 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-08-21
1 organization
1 product
1 indication
Organization
Sanofi PasteurIndication
Meningococcal Infection