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The goal of the registry is to develop a better understanding of the safety of Flucelvax in women and their offspring who were exposed to the vaccine during pregnancy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1, Flucelvax | Flucelvax exposure in pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flucelvax (cTIV) | Biological | vaccine exposure in routine care (no vaccination per protocol) |
|
| Measure | Description | Time Frame |
|---|---|---|
| major congenital malformation | From time of enrollment during pregnancy to time of delivery or pregnancy termination | |
| preterm birth | From time of enrollment during pregnancy to time of delivery or pregnancy termination | |
| low birth weight | From time of enrollment during pregnancy to time of delivery or pregnancy termination |
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| Measure | Description | Time Frame |
|---|---|---|
| Live birth | From time of enrollment during pregnancy to time of delivery or pregnancy termination | |
| stillbirth | From time of enrollment during pregnancy to time of delivery or pregnancy termination | |
Inclusion Criteria:
Exclusion Criteria:
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Pregnant women aged 18 years or older within the US who were immunized with the Flucelvax vaccine at any time during pregnancy.The registry will allow eligible pregnant women to selfenroll and also allow HCPs to report de-identified data on pregnancy exposures and outcomes
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD | Wilmington | North Carolina | 28401 | United States |
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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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| spontaneous abortion |
| From time of enrollment during pregnancy to time of delivery or pregnancy termination |
| ectopic pregnancy | From time of enrollment during pregnancy to time of delivery or pregnancy termination |
| molar pregnancy | From time of enrollment during pregnancy to time of delivery or pregnancy termination |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |