A Phase 4 interventional study of Standard dose influenza vaccine and MF59 adjuvanted influenza vaccine in Influenza Vaccination, Older Adults (65 Years and Older) and Immunosenescence, sponsored by Korea University Guro Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Korea University Guro Hospital · Phase 4, Interventional, and Prevention
The goal of this clinical trial is to compare immune responses to different influenza vaccine formulations in older adults and to understand how immune aging and repeated annual influenza vaccination affect these responses.
The main questions it aims to answer are:
Researchers will compare older adults who receive a standard dose, MF59 adjuvanted, or high dose influenza vaccine. Younger adults aged 19-49 years who receive a standard dose influenza vaccine will also be included as a reference group to help evaluate age related differences in immune responses.
Participants will:
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's planned enrollment of 180 is below the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Korea University Guro Hospital is the lead sponsor of 89 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Standard dose influenza vaccine
Biological: MF59 adjuvanted influenza vaccine
Biological: High dose influenza vaccine
Younger adults aged 19-49 years who receive a standard dose influenza vaccine and serve as a reference group for evaluating age related differences in immune responses
Biological: Standard dose influenza vaccine
A single intramuscular dose of standard dose influenza vaccine administered according to the approved prescribing information.
A single intramuscular dose of MF59 adjuvanted influenza vaccine administered according to the approved prescribing information.
A single intramuscular dose of high dose influenza vaccine administered according to the approved prescribing information.
Geometric mean titers of hemagglutination inhibition antibodies at 1 month after vaccination
Geometric mean titers (GMTs) of hemagglutination inhibition antibodies against each influenza vaccine strain will be assessed at 1 month after vaccination.
Time frame: 1 month after vaccination, annually for up to 3 years
Geometric mean fold rise in hemagglutination inhibition antibody titers at 1 month after vaccination
Geometric mean fold rises (GMFRs) in hemagglutination inhibition antibody titers from baseline to 1 month after vaccination will be assessed for each influenza vaccine strain.
Time frame: Baseline to 1 month after vaccination, annually for up to 3 years
Seroconversion rate following influenza vaccination
The proportion of participants achieving a prespecified serologic response, defined as a fourfold or greater increase in hemagglutination inhibition antibody titer from baseline, will be assessed for each vaccine strain.
Time frame: Baseline and 1 month after vaccination, annually for up to 3 years
Frequency of influenza specific B cells following vaccination
The frequency of influenza specific B cells will be assessed at baseline, 1 week, and 1 month after vaccination. Responses will be compared among vaccine formulations and evaluated according to age and repeated annual vaccination.
Time frame: Baseline, 1 week, and 1 month after vaccination, annually for up to 3 years
normalized level of influenza specific secretory IgA in nasal samples
Influenza specific secretory IgA will be measured in nasal samples and normalized to total protein concentration measured using the BCA assay. Normalized secretory IgA levels will be used to assess mucosal immune responses. A pilot assessment will be conducted during the first vaccination season, followed by assessment before and 1 month after vaccination during subsequent annual vaccination seasons to evaluate changes associated with repeated vaccination.
Time frame: 1 month after vaccination in the first season; baseline and 1 month after vaccination annually in year 2 and 3
Frequency of influenza specific T cells following vaccination
Influenza specific T cell responses will be assessed by measuring the frequency of antigen responsive T cells following stimulation with influenza antigens. Antigen specific T cells will be characterized using activation induced and functional markers.
Time frame: Baseline, 1 week, and 1 month after vaccination, annually for up to 3 years
Molecular immune signatures associated with influenza vaccine responses
Transcriptomic, miRNA, and proteomic analyses will be performed at selected time points to identify molecular signatures associated with vaccine induced immune responses, vaccine formulation, aging, and repeated annual vaccination. Integrated multiomics analyses will be used to explore molecular pathways and potential biomarkers associated with vaccine responsiveness.
Time frame: Through study completion, up to 3 years
Extracellular vesicle associated molecular signatures following influenza vaccination
Molecular profiles of extracellular vesicles, including exosomes, will be explored to identify biomarkers associated with vaccine induced immune responses, immune aging, and repeated annual vaccination.
Time frame: Through study completion, up to 3 years
Plan to share: No — Individual participant data sharing is not included in the current study protocol and informed consent.
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Studies of the drug tested here: MF59
Korea University Guro Hospital