Afluria Pregnancy Registry

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Observational Safety Study on Pregnancy Outcomes in Women Immunized With Afluria, a Seasonal Influenza Vaccine, During Pregnancy

Conditions
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Influenza, Human, Pregnancy, Birth Defect

Intervention / Treatment
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* Biological: Afluria Influenza Vaccine


Participation Criteria
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Eligibility Criteria
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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: Sufficient information to confirm that the exposure of interest occurred during pregnancy and at which date. Sufficient information to determine whether it concerns a prospectively enrolled subject, since retrospective cases are ineligible for enrollment. Reporter (e.g. HCP) contact information to allow for follow-up Exclusion Criteria: N/A
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Afluria<br>Afluria exposure in pregnancy | Biological: Afluria Influenza Vaccine<br>* Afluria is a seasonal influenza vaccine Vaccine exposure in routine care (no vaccination per protocol)<br>* Other names: Afluria;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |