Afluria Pregnancy Registry

Sponsor

Seqirus (Industry)

Overall Status

Completed

CT.gov ID

NCT03442582

Collaborator

(none)

490

Enrollment

Location

48.2

Actual Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza, Human Pregnancy Birth Defect	Biological: Afluria Influenza Vaccine

Study Design

Study Type:

Observational

Actual Enrollment :

490 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 8, 2017

Actual Primary Completion Date :

Sep 14, 2021

Actual Study Completion Date :

Sep 14, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Syneos Health	Wilmington	North Carolina	United States	28405

Sponsors and Collaborators

Seqirus

Investigators

Study Director: Head Epidemiology, Seqirus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seqirus

ClinicalTrials.gov Identifier:

NCT03442582

Other Study ID Numbers:

CSLCT-OBS-17-15

First Posted:

Feb 22, 2018

Last Update Posted:

Feb 9, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Influenza, Human

Congenital Abnormalities

Study Results

No Results Posted as of Feb 9, 2022