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

Last updated: November 1, 2024
Sponsor: Sanofi Pasteur, a Sanofi Company
Overall Status: Active - Recruiting

Phase

N/A

Condition

Meningococcal Infection

Treatment

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

Clinical Study ID

NCT04843111
MEQ00070
U1111-1250-2672
MEQ00070
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Menstrual Period (LMP).

Eligibility Criteria

Inclusion

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 inthe 30 days preceding the LMP;

  • Vaccine name (brand or generic) is provided (i.e., MenQuadfi®, Meningococcalvaccine, MenACWY conjugate vaccine), or not specified (eg, meningococcal vaccinefrom an unknown manufacturer).

Exclusion

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.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
Phase:
Study Start date:
March 05, 2021
Estimated Completion Date:
May 18, 2028

Study 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 prospective registration, which is defined as registration of a pregnancy exposure prior to knowledge or perceived knowledge of the pregnancy outcome.

Exposed pregnant women will be followed up to the end of their pregnancy, and the offspring(s) will be followed up to 1 year of age.

Connect with a study center

  • Investigational site

    Swiftwater, Pennsylvania 18370-0187
    United States

    Active - Recruiting

  • Pennsylvania Locations

    Swiftwater, Pennsylvania 18370-0187
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.