RECRUITING Phase 4 ClinicalTrials.gov

Influenza Vaccine Immunogenicity in Repeatedly Vaccinated Older Adults

Sponsor: Korea University Guro Hospital • ClinicalTrials.gov ID: NCT07838298

Registry updated: 2026-09-24

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Description

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: * Do standard dose, MF59 adjuvanted, and high dose influenza vaccines produce different immune responses in adults aged 65 years or older? * How does immune aging affect responses to different influenza vaccine formulations? * How do immune responses change with repeated annual influenza vaccination, and do these changes differ among vaccine formulations? 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: * Receive an influenza vaccine. * Provide blood samples before and after vaccination to measure antibody and other immune responses. * Some participants will provide additional blood or nasal samples for more detailed evaluation of immune responses.

Interventions

Standard dose influenza vaccine (Biological)
A single intramuscular dose of standard dose influenza vaccine administered according to the approved prescribing information.
MF59 adjuvanted influenza vaccine (Biological)
A single intramuscular dose of MF59 adjuvanted influenza vaccine administered according to the approved prescribing information.
High dose influenza vaccine (Biological)
A single intramuscular dose of high dose influenza vaccine administered according to the approved prescribing information.

Eligibility criteria

Inclusion Criteria: * Older adult group: aged 65 years or older * Younger reference group: aged 19 to 49 years * Able to receive influenza vaccination and complete the scheduled follow up Exclusion Criteria: * Receipt of an influenza vaccine or any other vaccine within 4 weeks prior to enrollment * Immunocompromised status, including ongoing chemotherapy or immunosuppressive therapy, high dose corticosteroid therapy, history of solid organ or hematopoietic stem cell transplantation, active malignancy, HIV infection, or other clinically significant immunocompromising conditions * Moderate or severe acute infection * History of allergic reaction to an influenza vaccine or any of its components, or any other condition that precludes influenza vaccination * Inability, as determined by the investigator, to understand the purpose and procedures of the study and provide voluntary informed consent

Conditions

Influenza Vaccination Older Adults (65 Years and Older) Immunosenescence Immunogenicity Repeated Vaccination

Locations

Korea University Guro Hospital — Seoul, South Korea

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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