Flucelvax Pregnancy Registry

Withdrawn

• Conditions: Pregnant Women, Influenza
• Interventions: Biological: Flucelvax (cTIV)

• Registration Number: NCT02258178
• Lead Sponsor: Seqirus

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-10-05
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1, Flucelvax	Flucelvax (cTIV)	Flucelvax exposure in pregnancy

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

PPD; 🇺🇸 Wilmington, North Carolina, United States