Afluria Pregnancy Registry

Completed

• Conditions: Influenza, Human; Pregnancy; Birth Defect
• Interventions: Biological: Afluria Influenza Vaccine

• Registration Number: NCT03442582
• Lead Sponsor: Seqirus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-08
• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-22
• Primary Completion: 2021-09-14
• Study Completion: 2021-09-14
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 490

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Afluria	Afluria Influenza Vaccine	Afluria exposure in pregnancy

Primary Outcome Measures

Name	Time	Method
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
Safety Objective: Number of cases for pregnancy outcomes 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	Pregnancy outcomes will be reported as one of the following: live birth, stillbirth, spontaneous abortion and elective termination
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

Trial Locations

Locations (1)

Syneos Health; 🇺🇸 Wilmington, North Carolina, United States