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The study is a population based prospective cohort study designed to collect data on pregnancy outcomes and events of interest among women immunized with Afluria during pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afluria | Afluria exposure in pregnancy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afluria Influenza Vaccine | Biological | Afluria is a seasonal influenza vaccine Vaccine exposure in routine care (no vaccination per protocol) |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Objective: Number of cases for pregnancy outcomes among women immunized as part of routine care with Afluria, a seasonal influenza vaccine, during pregnancy. | Pregnancy outcomes will be reported as one of the following: live birth, stillbirth, spontaneous abortion and elective termination | From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks |
| Safety Objective: Number of cases with events of major congenital malformations among women immunized as part of routine care with Afluria, a seasonal influenza vaccine, during pregnancy. | From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks | |
| Safety Objective: Number of cases of events of preterm birth among women immunized as part of routine care with Afluria, a seasonal influenza vaccine, during pregnancy. | From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks | |
| Safety Objective: Number of cases of events of low birth weight among women immunized as part of routine care with Afluria, a seasonal influenza vaccine, during pregnancy. | From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks |
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Inclusion Criteria:
Enrollment and data collection will be coordinated through a coordination center (CC). The minimum eligibility criteria required for enrollment are as follows:
Exclusion Criteria:
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The study population will include pregnant women within the US who were immunized with Afluria as part of routine care at any time during pregnancy. Eligible pregnant women may self-enroll or voluntarily be enrolled by their HCP.
Women under 18 can be included in the study as long as parental consent can be obtained, according to IRB requirements and local laws and regulations.
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| Name | Affiliation | Role |
|---|---|---|
| Head Epidemiology | Seqirus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syneos Health | Wilmington | North Carolina | 28405 | United States |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000613428 | Afluria |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |