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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1250-2672 | Registry Identifier | ICTRP | |
| MEQ00070 | Other Identifier | Sanofi Identifier |
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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 MenQuadfiâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women and their offspring(s) | Pregnant women and their offspring(s) exposed to MenQuadfi® during their pregnancy or within 30 days prior to their LMP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine | Biological | Pharmaceutical form: Solution for injection Route of administration: Intramuscular |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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) | On day of birth |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From day of birth to 28 days post-birth |
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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:
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.
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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 last menstrual period (LMP), for whom the exposure is reported to the pregnancy registry.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free number for US & Canada) | Contact | 800-633-1610 | option 6 | Contact-Us@sanofi.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennsylvania Locations | Recruiting | Swiftwater | Pennsylvania | 18370-0187 | United States |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| 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 |
| From day 29 post-birth to 365 days post-birth |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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