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

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Apr 8, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the health outcomes of pregnant women and their babies who received a vaccine called MenQuadfi® during pregnancy or shortly before becoming pregnant. The main goal is to gather information about how this vaccine affects mothers and their newborns. By doing this, researchers hope to understand better the safety and effects of the vaccine on both the mothers and their infants.

To be eligible for this study, women must be pregnant or have recently been pregnant and have received the MenQuadfi® vaccine during their pregnancy or within 30 days before their last menstrual period. It's important that the vaccine is confirmed, and the information about its use is reported to the study registry. Participants will not need to go through any clinical trials but will instead contribute information based on their experiences. This study is currently recruiting women from the U.S. and its territories, and everyone’s participation will help provide valuable insights into the vaccine's safety for mothers and their babies.

Gender

ALL

Eligibility criteria

• 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.