Afluria Pregnancy Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

490 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-08

Study Completion Date

2021-09-14

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.

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Detailed Description

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Conditions

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Influenza, Human Pregnancy Birth Defect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Afluria

Afluria exposure in pregnancy

Afluria Influenza Vaccine

Intervention Type BIOLOGICAL

Afluria is a seasonal influenza vaccine

Vaccine exposure in routine care (no vaccination per protocol)

Interventions

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Afluria Influenza Vaccine

Afluria is a seasonal influenza vaccine

Vaccine exposure in routine care (no vaccination per protocol)

Intervention Type BIOLOGICAL

Other Intervention Names

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Afluria

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