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

Sanofi Pasteur, a Sanofi Company50 enrolled

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Meningococcal Infection

Interventions

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

Pharmaceutical form: Solution for injection Route of administration: Intramuscular

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pennsylvania Locations

Swiftwater, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

Percentage of pregnant women with maternal adverse events (AEs)

Maternal adverse events defined as any reported adverse event (AE), following vaccination of a pregnant woman, occurring independent of the pregnancy (e.g., injection site reactions)

Time frame: From vaccination to end of follow-up (i.e.,up to 22 months after cohort entry)

Percentage of pregnant women with obstetrical AEs

Obstetrical adverse events defined as any reported AE, following vaccination of a pregnant woman, related directly to the pregnancy (e.g., complications of pregnancy, labor and delivery, and puerperium)

Time frame: From vaccination to 28 days after delivery

Percentage of pregnant women with pregnancy AEs

Pregnancy adverse events defined as any reported AE, following vaccination of a pregnant woman, related to birth outcomes (e.g., live birth, spontaneous abortion/miscarriage, stillbirth/fetal death)

Time frame: On day of birth

Secondary Outcomes

Percentage of offsprings with adverse neonatal AEs

Neonatal events defined as any reported AE, following vaccination of a pregnant woman, directly related to the infant and assessed immediately after birth or within the first 28 days of life (e.g., congenital anomalies)

Time frame: From day of birth to 28 days post-birth

Percentage of offsprings with adverse infant AEs

Infant events defined as any reported AE, following vaccination of a pregnant woman, directly related to the infant occurring / diagnosed between days 29 and 365 post-birth

Time frame: From day 29 post-birth to 365 days post-birth

Central Contacts

Trial Transparency email recommended (Toll free number for US & Canada)

CONTACT

800-633-1610 Contact-Us@sanofi.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.