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

ConditionMeningococcal Infection

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorSanofi Pasteur, a Sanofi Company

About this trial

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 criteria

Qualifiers

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).

Disqualifiers

None

Trial design

Treatments tested in this trial

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

Treatment groups

50 Participants

are divided into 1 treatment group

Sponsors and collaborators

Sanofi Pasteur, a Sanofi Company

Lead sponsor

Source ClinicalTrials.gov