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

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).

Conditions

Meningococcal Infection

Study Overview

Study Details

Study overview

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).

The MenQuadfi® Pregnancy Registry: A Surveillance Registry to Assess the Safety of MenQuadfi® Among Exposed Pregnant Women and Their Offspring

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

Condition
Meningococcal Infection
Intervention / Treatment

-

Contacts and Locations

Swiftwater

Pennsylvania Locations, Swiftwater, Pennsylvania, United States, 18370-0187

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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).

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Sanofi Pasteur, a Sanofi Company,

Clinical Sciences & Operations, STUDY_DIRECTOR, Sanofi

Study Record Dates

2028-05-18