Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age
NCT ID: NCT05501561
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
1056 participants
INTERVENTIONAL
2022-08-25
2023-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults
NCT04576702
Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults
NCT04782323
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
Study to Evaluate Immunogenicity, Safety and Tolerability of Adjuvanted and Non-Adjuvanted H2N3 Influenza Vaccines in Adults
NCT05875961
Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults
NCT03314662
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IIV-A Investigational
Experimental: IIV-A Investigational IIV-A will be administered as a single dose intramuscularly on Day 1
Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
aIIV-B Investigational
Experimental: aIIV-B Investigational aIIV-B will be administered as a single dose intramuscularly on Day 1
Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
aIIV-C Investigational
Experimental: aIIV-C Investigational aIIV-C will be administered as a single dose intramuscularly on Day 1
Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Licensed IIV
Active Comparator: Licensed IIV IIV will be administered as a single dose intramuscularly on Day 1
Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Active Comparator: Licensed IIV IIV will be administered as a single dose intramuscularly on Day 1
Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Experimental: IIV-A Investigational IIV-A will be administered as a single dose intramuscularly on Day 1
Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Experimental: aIIV-B Investigational aIIV-B will be administered as a single dose intramuscularly on Day 1
Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Experimental: aIIV-C Investigational aIIV-C will be administered as a single dose intramuscularly on Day 1
Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
\-
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seqirus
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AMR Tempe
Tempe, Arizona, United States
Marvel Clinical Research
Huntington Beach, California, United States
California Research Center
San Diego, California, United States
The Lynn Institute of The Rockies
Colorado Springs, Colorado, United States
Clinical Research Consulting, LLC
Milford, Connecticut, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States
Velocity Clinical Research - New Smyrna Beach
Edgewater, Florida, United States
CenExel RCA
Hollywood, Florida, United States
Health Awareness INC
Jupiter, Florida, United States
Global Health Research Center
Miami Lakes, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Global Health Research Center
Tampa, Florida, United States
Platinum Research Network, LLC
Savannah, Georgia, United States
Meridian Clinical Research - Savannah
Savannah, Georgia, United States
AMR El Dorado
El Dorado, Kansas, United States
AMR Lexington
Lexington, Kentucky, United States
Meridian Clinical Research
Baton Rouge, Louisiana, United States
Medpharmics, LLC
Metairie, Louisiana, United States
Rockville Internal Medicine Group
Rockville, Maryland, United States
MedPharmics LLC
Biloxi, Mississippi, United States
Healthcare Research Network
Hazelwood, Missouri, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Meridian Clinical Research
Bellevue, Nebraska, United States
Meridian Clinical Research
Grand Island, Nebraska, United States
Meridian Clinical Research, LLC
Lincoln, Nebraska, United States
Alliance for Multispecialty Research, LLC, Las Vegas
Las Vegas, Nevada, United States
Meridian Clinical Research (Binghamton, NY)
Binghamton, New York, United States
Meridian Clinical Research, LLC
Endwell, New York, United States
Velocity Clinical Research - Syracuse
Syracuse, New York, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
Meridian Clinical Research, LLC
Cincinnati, Ohio, United States
Meridian Clinical Research, LLC
Cincinnati, Ohio, United States
Aventiv Research, Inc. Columbus
Columbus, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Velocity Clinical Research - Medford
Medford, Oregon, United States
Velocity Clinical Research, Gaffney
Gaffney, South Carolina, United States
Velocity Clinical Research - Greenville
Greenville, South Carolina, United States
Velocity Clinical Research, Spartanburg
Spartanburg, South Carolina, United States
Meridian Clinical Research - Dakota Dunes
Dakota Dunes, South Dakota, United States
AMR Coastal Clinical Research
Knoxville, Tennessee, United States
DM Clinical Research
Tomball, Texas, United States
JBR Clinical Research
Salt Lake City, Utah, United States
Velocity Clinical Research - West Jordan
West Jordan, Utah, United States
CVS pharmacy - Charlottesville
Charlottesville, Virginia, United States
CVS pharmacy - Reston
Reston, Virginia, United States
CVS pharmacy - Richmond
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
V201_07
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.