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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1143-8433 | Other Identifier | WHO |
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The Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes.
Pregnant women will be enrolled in the registry prospectively (after exposure to QIV in routine clinical settings but before knowledge of the pregnancy outcome). Women exposed to QIV with or without adverse events will be recorded in the Global Pharmacovigilance Database and medically reviewed. Pregnancy outcomes will be sought via questionnaires sent to the reporter at enrollment, estimated time of delivery, and six months after delivery. Descriptive statistical methods will be the primary approach for summarizing data.
No vaccine products will be provided or administered as part of this registry protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnancy Cases | Pregnant women exposed to Sanofi Pasteur's Quadrivalent Influenza Vaccine (QIV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Influenza Vaccine (QIV) | Biological | No Intervention as part of this protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of cases and outcomes of pregnancies following exposure to QIV vaccine | Data will be summarized using descriptive statistical methods and stratified by pregnancy outcome (spontaneous abortion, elective termination, fetal death/stillbirth, live birth) and timing of vaccine exposure. Infant outcomes include birth defects and physical and social development. | Up to six years |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women exposed to Sanofi Pasteur's Quadrivalent Influenza Vaccine (QIV)
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34520127 | Derived | Ledlie S, Gandhi-Banga S, Shrestha A, Mallett Moore T, Khromava A. Exposure to quadrivalent influenza vaccine during pregnancy: Results from a global pregnancy registry. Influenza Other Respir Viruses. 2022 Jan;16(1):90-100. doi: 10.1111/irv.12897. Epub 2021 Sep 14. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Albany |
| New York |
| United States |
| Columbus | Ohio | United States |
| Harrisburg | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Related Info | View source |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |