Meningococcal Infection
Conditions
Brief 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).
Detailed 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.
Interventions
Pharmaceutical form: Solution for injection Route of administration: Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of pregnant women with maternal adverse events (AEs) | From vaccination to end of follow-up (i.e.,up to 22 months after cohort entry) | 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) |
| Percentage of pregnant women with obstetrical AEs | From vaccination to 28 days after delivery | 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) |
| Percentage of pregnant women with pregnancy AEs | On day of birth | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of offsprings with adverse neonatal AEs | From day of birth to 28 days post-birth | 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) |
| Percentage of offsprings with adverse infant AEs | From day 29 post-birth to 365 days post-birth | 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 |
Countries
United States
Contacts
Primary ContactTrial Transparency email recommended (Toll free number for US & Canada)
Outcome results
None listed