Afluria Pregnancy Registry

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Influenza, Human; Birth Defect
• Intervention / Treatment: Biological: Afluria Influenza Vaccine

• Study Type: Observational
• Enrollment (Actual): 490

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Wilmington, North Carolina, United States, 28405
      • Syneos Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Afluria; Afluria exposure in pregnancy	Biological: Afluria Influenza Vaccine; Afluria is a seasonal influenza vaccine Vaccine exposure in routine care (no vaccination per protocol); Other Names: Afluria

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seqirus
• Investigators: Study Director: Head Epidemiology, Seqirus

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2017
• Primary Completion (Actual): September 14, 2021
• Study Completion (Actual): September 14, 2021

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Congenital Abnormalities; Influenza, Human
• Other Study ID Numbers: CSLCT-OBS-17-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No