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

Part of paid clinical trials in Swiftwater, Pennsylvania.

Sponsor
Sanofi Pasteur, a Sanofi Company
Study ID
NCT04843111
Status
Recruiting
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Conditions

  • Meningococcal Infection

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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 Dates

Start date
Mar 5, 2021
Status verified
Nov 2025
Primary completion
May 18, 2028
Completion
May 18, 2028

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Pregnant women and their offspring(s)
    Pregnant women and their offspring(s) exposed to MenQuadfi® during their pregnancy or within 30 days prior to their LMP

Primary Outcome Measure

Percentage of pregnant women with maternal adverse events (AEs) [ Time Frame: From vaccination to end of follow-up (i.e.,up to 22 months after cohort entry) ]

Central Contacts

  • Trial Transparency email recommended (Toll free number for US & Canada)
    800-633-1610
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Pennsylvania LocationsSwiftwaterPennsylvania18370-0187-

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Pennsylvania Locations· Swiftwater, PA