Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults

Completed · Phase 3

Conditions studied: Influenza, Human

In brief

This phase 3 study is a randomized, double-blinded, comparator controlled, parallel-group, multicenter study of aQIV versus the US-licensed 2017-2018 adjuvanted trivalent influenza vaccine (aTIV-1, Fluad), and versus an adjuvanted trivalent influenza vaccine (aTIV-2), containing the alternate B strain.

Key facts

Study ID

NCT03314662

Run by

Seqirus

People needed

1778

Starts

2017-10-17

Expected to finish

2018-05-17

Last updated by the study team

2020-07-22

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and females ≥ 65 years old who are healthy or have co-morbidities
• Individuals who or whose legal representative(s) have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
• Ability to attend all scheduled visits and to comply with study procedures including diary card completion and follow-up

You may not qualify if…

• History of behavioral or cognitive impairment or psychiatric condition
• Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
• Abnormal function of the immune system
• Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or plan to receive influenza vaccine prior to the Day 22 blood collection
• Any other clinical condition that, in the opinion of the Investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study
• Additional eligibility criteria may be discussed by contacting the site.

Where it is running

• Coastal Clinical Research, Inc. — Mobile, Alabama, United States
• Anaheim Clinical Trials — Anaheim, California, United States
• Paradigm clinical Research Centers, Inc — Redding, California, United States
• Clinical Research of South Florida, an AMR Company — Coral Gables, Florida, United States
• Meridan Clinical Research, LLC — Savannah, Georgia, United States
• Advanced Clinical Research — Meridian, Idaho, United States
• Johnson County Clin-Trials — Lenexa, Kansas, United States
• Heartland Research Associates, LLC - An AMR Company — Newton, Kansas, United States
• Heartland Research Associates, LLC - An AMR Company — Wichita, Kansas, United States
• Center for Pharmaceutical Research, LLC — Kansas City, Missouri, United States
• Sundance Clinical Research, LLC — St Louis, Missouri, United States
• Meridian Clinical Research, LLC — Omaha, Nebraska, United States
• United Medical Associates — Binghamton, New York, United States
• Rapid Medical Research, Inc. — Cleveland, Ohio, United States
• Medical Research South — Charleston, South Carolina, United States
• New Orleans Center for Clinical Research — Knoxville, Tennessee, United States
• Benchmark Research — Fort Worth, Texas, United States
• Benchmark Research — San Angelo, Texas, United States
• Martin Diagnostic Clinic — Tomball, Texas, United States
• Advanced Clinical Research — West Jordan, Utah, United States

Full record on ClinicalTrials.gov

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