NCT03438487

Flucelvax (TIVc or QIVc) Pregnancy Registry

A Prospective Observational Safety Study on Pregnancy Outcomes in Women Immunized With Seasonal Cell Culture Influenza Trivalent (TIVc) or Quadrivalent (QIVc) Vaccine During Pregnancy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 692 (actual)
• Sponsor: Seqirus · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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 the TIVc or QIVc vaccine during pregnancy.

Conditions

• Influenza, Human
• Pregnancy
• Birth Defect

Interventions

Type	Name	Description
BIOLOGICAL	Flucelvax Trivalent Influenza Vaccine	Flucelvax is a cell culture seasonal trivalent influenza vaccine that contains the following influenza hemagglutinin antigens: 1) A/H1N1-like virus, 2) A/(H3N2)-like virus, 3) B/Yamagata lineage or B/Victoria lineage Vaccine exposure in routine care (no vaccination per protocol)
BIOLOGICAL	Flucelvax Quadrivalent Influenza Vaccine	Flucelvax Quadrivalent is a cell culture seasonal quadrivalent influenza vaccine that contains the following influenza hemagglutinin antigens: 1) A/H1N1-like virus, 2) A/(H3N2)-like virus, 3) B/Yamagata lineage, 4) B/Victoria lineage Vaccine exposure in routine care (no vaccination per protocol)

Timeline

• Start date: 2017-09-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-02-19
• Last updated: 2022-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study