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Flucelvax (TIVc or QIVc) Pregnancy Registry

NCT03438487 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 692

Last updated 2022-11-04

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Seqirus

    lead INDUSTRY

Principal Investigators

  • Head Epidemiology · Seqirus

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03438487 on ClinicalTrials.gov