Clinical Trials Listing Service

Flu Vaccine

Last updated: September 22, 2023
Sponsor: Seqirus
Overall Status: Active - Recruiting

Phase

3

Condition

Vaccines

Influenza

Treatment

N/A

Clinical Study ID

TX318205
V201_03
  • Ages 50-99
  • All Genders

Study Summary

A Phase 3, Randomized, Observer-Blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of a High-Dose MF59-Adjuvanted Quadrivalent Subunit Cellderived Influenza Vaccine (aQIVc HD) in Comparison with a Non-adjuvanted Quadrivalent Recombinant Influenza Vaccine (QIVr) and an MF59-Adjuvanted Quadrivalent Subunit Eggderived Influenza Vaccine (aQIV), in Adults Aged 50 Years and Older.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Individuals ≥50 years of age on the day of informed consent
  • Healthy individuals or individuals with stable comorbidities which increase their risk of complications from influenza infection.

Exclusion

Exclusion Criteria:

  • Progressive, unstable, or uncontrolled clinical conditions.
  • Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study.
  • Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.

Study Design

Study Start date:
Estimated Completion Date:

Study Description

  • Condition: Flu Vaccine
  • Clinical Trial Identifier: NA
  • Sponsor: Seqirus

Connect with a study center

  • AMR Kansas City (formerly Center for Pharmaceutical Research)

    Kansas City, Missouri 64114
    United States

    Active - Recruiting

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