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

Completed · Phase 3

Conditions studied: Influenza, Human

In brief

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.

Key facts

Study ID: NCT05044195
Run by: Seqirus
People needed: 2044
Starts: 2021-09-30
Expected to finish: 2022-09-09
Last updated by the study team: 2023-09-28

Who can join

Age: 50 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

In order to participate in this study, all subjects must meet ALL of the following inclusion criteria:
Individuals 50 to 64 years of age (i.e. 50 to ≤64 years) on the day of informed consent
Individuals who have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
Individuals who can comply with study procedures including follow-up
Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method, at least 30 days prior to informed consent, which they intend to use for at least 2 months after the study vaccination

You may not qualify if…

In order to participate in this study, all subjects must not meet ANY of the exclusion criteria described below:
Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to study entry and who do not plan to do so until 2 months after the study vaccination
Progressive, unstable or uncontrolled clinical conditions
Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
History of any medical condition considered an AESI
Known history of Guillain Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis
Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
Abnormal function of the immune system resulting from:
Clinical conditions
Systemic administration of corticosteroids (PO/IV/IM) at a dose equivalent to ≥20 mg/day of prednisone for more than 14 consecutive days within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids is also permitted
Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent
Received immunoglobulins or any blood products within 180 days prior to informed consent
Received an investigational or non-registered medicinal product within 30 days prior to informed consent, or who are unwilling to refuse participation in another clinical study at any time during the conduct of this study (notes: i. concomitant participation in a study not involving or no longer involving administration of drugs, vaccines, or medical devices, is acceptable (e.g. studies in safety follow-up phase, observational studies); ii. concomitant participation in a COVID-19 vaccine study is acceptable provided that the vaccine dosing interval mentioned in Exclusion Criterion #11 is adhered to)
Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or plan to receive influenza vaccine during the study period
Receipt of any (investigational or licensed) COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to enrollment or plan to receive any COVID-19 vaccine within 7 days from study vaccination
Receipt of any inactivated non-influenza vaccine within 14 days or live-attenuated vaccine within 28 days prior to enrollment in this study or plan to receive any other non-influenza vaccine within 28 days from study vaccination
Acute (severe) febrile illness
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
Study personnel or immediate family members or household member of study personnel

Where it is running

84013 Coastal Clinical Research, Inc. — Mobile, Alabama, United States
84007 Alliance for Multispecialty Research — Tempe, Arizona, United States
84005 JEM Research Institute — Atlantis, Florida, United States
84010 Headlands Research Orlando — Orlando, Florida, United States
84001 Meridian Clinical Research — Savannah, Georgia, United States
84003 Meridian Clinical Research — Sioux City, Iowa, United States
84006 Alliance for Multispecialty Research — Kansas City, Missouri, United States
84009 Meridian Clinical Research — Lincoln, Nebraska, United States
84002 Meridian Clinical Research — Norfolk, Nebraska, United States
84004 Meridian Clinical Research — Omaha, Nebraska, United States
84008 United Medical Associates — Binghamton, New York, United States
84011 Meridian Clinical Research — Endwell, New York, United States
23302 Vee Family Doctors Centre — Paide, Estonia
23301 Innomedica OÜ - Outpatient — Tallinn, Estonia
23303 Al Mare Perearstikeskus OÜ — Tallinn, Estonia
23304 Merelahe Family Doctors Centre — Tallinn, Estonia
23306 Center for Clinical and Basic Research — Tallinn, Estonia
23305 Clinical Research Center - Vaccine Trials — Tartu, Estonia
27602 Klinische Forschung Berlin — Berlin, Germany
27603 Emovis GmbH — Berlin, Germany
27608 Klinische Forschung Dresden GmbH — Dresden, Germany
27609 IKF Pneumologie GmbH & Co. KG — Frankfurt, Germany
27611 Siteworks GmbH — Fulda, Germany
27601 Klinische Forschung Hamburg GmbH — Hamburg, Germany
27605 Clinical Research Hamburg GmbH — Hamburg, Germany

Full record on ClinicalTrials.gov

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