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

Sanofi

Status: Enrolling

Conditions: Meningococcal Infection

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04843111

U1111-1250-2672 (Other Identifier)

MEQ00070

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Pregnant women and their offspring(s)

Description:

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

Treatment:

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