Influenza, Human

Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age

NCT05501561 | PHASE 2 | INTERVENTIONAL

This Phase 2, randomized, observer-blind, dose-confirmation Clinical study is evaluating different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 1000 subjects are to be randomized into 1 of 4 possible treatment groups with 250 participants per group. Every participant will receive an influenza vaccine injection on Day 1 and will be followed up for approximately 6 months following injection. The primary immunogenicity analysis is based on Day 29 serology data.

47 Sites

1056 Participants

Recruiting

50 Years to 11 Years

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Find closest sites:

SUBMIT

AMR Tempe

Tempe,Arizona,United States,85281

Marvel Clinical Research

Huntington Beach,California,United States,92647

California Research Center

San Diego,California,United States,92123

The Lynn Institute of The Rockies

Colorado Springs,Colorado,United States,80920

Clinical Research Consulting, LLC

Milford,Connecticut,United States,06460

Innovative Research of West Florida, Inc.

Clearwater,Florida,United States,33756

Velocity Clinical Research New Smyrna Beach

Edgewater,Florida,United States,32132

CenExel RCA

Hollywood,Florida,United States,33024

Health Awareness INC

Jupiter,Florida,United States,33458

Global Health Research Center

Miami Lakes,Florida,United States,33016

Precision Clinical Research

Sunrise,Florida,United States,33351

Global Health Research Center

Tampa,Florida,United States,33615

Platinum Research Network, LLC

Savannah,Georgia,United States,31405

Meridian Clinical Research Savannah

Savannah,Georgia,United States,31406

AMR El Dorado

El Dorado,Kansas,United States,67042

AMR Lexington

Lexington,Kentucky,United States,40509

Meridian Clinical Research

Baton Rouge,Louisiana,United States,70808

Medpharmics, LLC

Metairie,Louisiana,United States,70006

Rockville Internal Medicine Group

Rockville,Maryland,United States,20854

MedPharmics LLC

Biloxi,Mississippi,United States,39531

Healthcare Research Network

Hazelwood,Missouri,United States,63042

The Center for Pharmaceutical Research

Kansas City,Missouri,United States,64114

Sundance Clinical Research, LLC

Saint Louis,Missouri,United States,63141

Meridian Clinical Research

Bellevue,Nebraska,United States,68005

Meridian Clinical Research

Grand Island,Nebraska,United States,68803

Meridian Clinical Research, LLC

Lincoln,Nebraska,United States,68510

Alliance for Multispecialty Research, LLC, Las Vegas

Las Vegas,Nevada,United States,89119

Meridian Clinical Research (Binghamton, NY)

Binghamton,New York,United States,13901

Meridian Clinical Research, LLC

Endwell,New York,United States,13760

Velocity Clinical Research Syracuse

Syracuse,New York,United States,13057

M Wake Research, Inc.

Raleigh,North Carolina,United States,27612

Meridian Clinical Research, LLC

Cincinnati,Ohio,United States,45219

Meridian Clinical Research, LLC

Cincinnati,Ohio,United States,45246

Aventiv Research, Inc. Columbus

Columbus,Ohio,United States,43213

Lynn Health Science Institute

Oklahoma City,Oklahoma,United States,73112

Velocity Clinical Research Medford

Medford,Oregon,United States,97504

Velocity Clinical Research, Gaffney

Gaffney,South Carolina,United States,29340

Velocity Clinical Research Greenville

Greenville,South Carolina,United States,29615

Velocity Clinical Research, Spartanburg

Spartanburg,South Carolina,United States,29303

Meridian Clinical Research Dakota Dunes

Dakota Dunes,South Dakota,United States,57049

AMR Coastal Clinical Research

Knoxville,Tennessee,United States,37920

DM Clinical Research

Tomball,Texas,United States,77375

JBR Clinical Research

Salt Lake City,Utah,United States,84107

Velocity Clinical Research West Jordan

West Jordan,Utah,United States,84088

CVS pharmacy Charlottesville

Charlottesville,Virginia,United States,22902

CVS pharmacy Reston

Reston,Virginia,United States,20190

CVS pharmacy Richmond

Richmond,Virginia,United States,23235

Study Eligibility Criteria

Inclusion Criteria

In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
1. Individuals ≥50 years of age on the day of informed consent.
2. 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.
3. Individuals who can comply with study procedures including follow-up .
4. 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.
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Exclusion Criteria

In order to participate in this study, all subjects must not meet ANY of the exclusion criteria described below:
1. 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 informed consent and who do not plan to do so for at least 2 months after the study vaccination.
2. Progressive, unstable or uncontrolled clinical conditions.
3. Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study.
4. History of any medical condition considered an adverse event of special interest (AESI).
5. Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
6. Clinical conditions representing a contraindication to intramuscular administration of vaccines or blood draw.
7. Abnormal function of the immune system resulting from:
1. Clinical conditions.
2. Systemic administration of corticosteroids (PO/IV/IM) at a dose of ≥20 mg/day of prednisone or equivalent for more than 14 consecutive days within 90 days prior to informed consent5.
3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
8. Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
9. Receipt of an investigational or non-registered medicinal product within 30 days prior to informed consent.
10. Receipt of any COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to informed consent or plan to receive any COVID-19 vaccine within 7 days from study vaccination
11. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to informed consent or who are planning to receive any vaccine within 28 days from the study vaccines.
12. Study personnel or immediate family or household member of study personnel.
13. Receipt of any influenza vaccine within 6 months prior to informed consent, or plan to receive an influenza vaccine during the study period.
14. Acute (severe) febrile illness,
15. 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.
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Additional Studies

Additional studies can be found at ClinicalTrials.gov