Flucelvax Pregnancy Registry

Flucelvax Pregnancy Registry: an Observational Study on the Safety of Flucelvax Exposure in Pregnant Women and Their Offspring

The goal of the registry is to develop a better understanding of the safety of Flucelvax in women and their offspring who were exposed to the vaccine during pregnancy

Study Overview

• Status: Withdrawn
• Conditions: Pregnant Women, Influenza
• Intervention / Treatment: Biological: Flucelvax (cTIV)

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • PPD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women aged 18 years or older within the US who were immunized with the Flucelvax vaccine at any time during pregnancy.The registry will allow eligible pregnant women to selfenroll and also allow HCPs to report de-identified data on pregnancy exposures and outcomes

Description

Inclusion Criteria:

• Pregnancy women pregnant women aged 18 years or older within the US who were immunized with the Flucelvax vaccine at any time during pregnancy.The registry will allow eligible pregnant women to selfenroll and also allow HCPs to report de-identified data on pregnancy exposures and outcomes.
• Sufficient evidence to confirm that Flucelvax exposure occurred during pregnancy
• Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (ie, whether the outcome of pregnancy was known at the time of first contact with the registry)
• Date the pregnancy exposure is registered
• Full reporter (ie, HCP) contact information to allow for follow-up (name, address,etc) The primary population for analysis will include prospectively enrolled pregnancies exposed to Flucelvax that are not lost to follow-up (ie, with outcome information that meet the minimum criteria for evaluation)

Exclusion Criteria:

• Invalid registry reports and pregnancies deemed lost to follow-up will be excluded from the primary analysis. Retrospective reports will not be included, although retrospective cases with MCMs will be reviewed and reported separately.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1, Flucelvax; Flucelvax exposure in pregnancy	Biological: Flucelvax (cTIV); vaccine exposure in routine care (no vaccination per protocol)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
major congenital malformation	From time of enrollment during pregnancy to time of delivery or pregnancy termination
preterm birth	From time of enrollment during pregnancy to time of delivery or pregnancy termination
low birth weight	From time of enrollment during pregnancy to time of delivery or pregnancy termination

Other Outcome Measures

Outcome Measure	Time Frame
Live birth	From time of enrollment during pregnancy to time of delivery or pregnancy termination
stillbirth	From time of enrollment during pregnancy to time of delivery or pregnancy termination
spontaneous abortion	From time of enrollment during pregnancy to time of delivery or pregnancy termination
ectopic pregnancy	From time of enrollment during pregnancy to time of delivery or pregnancy termination
molar pregnancy	From time of enrollment during pregnancy to time of delivery or pregnancy termination

Collaborators and Investigators

• Sponsor: Seqirus

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: October 6, 2014
• First Posted (Estimate): October 7, 2014

Study Record Updates

• Last Update Posted (Actual): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: V58_36OB