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A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age

NCT05044195 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2044

Last updated 2023-09-28

Study results available
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Summary

This Phase 3 study is a randomized, observer-blind immunogenicity and safety study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent influenza vaccine in adults 50 to 64 years of age.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

aQIV

Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1

BIOLOGICAL

Comparator QIV

Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1

Sponsors & Collaborators

  • Seqirus

    lead INDUSTRY

Principal Investigators

  • Clinical Program Director · Seqirus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2022-01-18
Completion
2022-09-09
FDA Drug
Yes

Countries

  • United States
  • Estonia
  • Germany

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 NCT05044195 on ClinicalTrials.gov