Influenza

Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults

NCT04576702 | PHASE 2 | INTERVENTIONAL

This Phase 2, randomized, observer-blind, active controlled clinical study is evaluating the safety and immunogenicity of the investigational MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 480 subjects are to be randomized into 1 of 4 possible treatment groups (investigational Influenza Vaccine or licensed Quadrivalent Influenza Vaccine comparators) at 120 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 serum.

21 Sites

471 Participants

Recruiting

50 Years to 8 Years

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Find closest sites:

SUBMIT

Coastal Clinical Research, an AMR company

Mobile,Alabama,United States,36608

Clinical Research Consortium, an AMR company

Tempe,Arizona,United States,85283

Westside Center for Clinical Research

Jacksonville,Florida,United States,32205

Jacksonville Center for Clinical Research

Jacksonville,Florida,United States,32216

Research Centers of America, LLC

Oakland,Florida,United States,33334

Advanced Clinical Research

Boise,Idaho,United States,83642

Heartland Research Associates, LLC

Newton,Kansas,United States,67114

Heartland Research Associates, LLC An AMR Company

Wichita,Kansas,United States,67207

Central Kentucky Research Associates, an AMR company

Lexington,Kentucky,United States,40509

Medpharmi

Kenner,Louisiana,United States,70065

The Center for Pharmaceutical Research, an AMR company

Kansas City,Missouri,United States,64114

Sundance Clinical Research, LLC

Saint Louis,Missouri,United States,63141

Meridian Clinical Research, LLC

Omaha,Nebraska,United States,68134

Regional Clinical Research United Medical Associates

Binghamton,New York,United States,13901

M Wake Research, Inc.

Raleigh,North Carolina,United States,27612

Sterling research

Cincinnati,Ohio,United States,45219

Rapid Medical Research, Inc.

Cleveland,Ohio,United States,44122

Lynn Health Science Institute

Oklahoma City,Oklahoma,United States,73112

Clinical Trials of Texas, Inc.

San Antonio,Texas,United States,78229

Martin Diagnostic Clinic

Tomball,Texas,United States,77375

Advanced Clinical Research

West Jordan,Utah,United States,84088

Study Eligibility Criteria

Inclusion Criteria

1. Individuals 50 years of age and older 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.

Exclusion Criteria

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 until 2 months after the study vaccination.
2. Progressive, unstable or uncontrolled clinical conditions.
3. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
4. History of any medical condition considered an adverse event of special interest.
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. Received immunoglobulins or any blood products within 180 days prior to informed consent.
9. Received an investigational or non-registered medicinal product within 30 days prior to vaccination.
10. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
11. Study personnel or immediate family or household member of study personnel.
12. Receipt of any influenza vaccine within 6 months prior to vaccination in this study, or plan to receive an influenza vaccine during the study period.
13. Acute (severe) febrile illness
14. 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 Studies

Additional studies can be found at ClinicalTrials.gov