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Comparative Immunologic Mechanisms and Microbiome Interactions Following Different Influenza Vaccine Formulations in Older Adults

NCT07805837 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2026-09-04

No results posted yet for this study

Summary

This prospective, randomized, open-label clinical study aims to evaluate the immunogenicity and underlying immune mechanisms of different influenza vaccine formulations in adults aged ≥65 years. Additionally, the study investigates the role of the gut microbiome in modulating vaccine-induced immune responses and durability.

Conditions

  • Influenza
  • Influenza Vaccines
  • Microbiome
  • Immune Response

Interventions

BIOLOGICAL

Standard-Dose Influenza Vaccine

0.5 mL intramuscular injection, single dose

BIOLOGICAL

MF59-Adjuvanted Influenza Vaccine

0.5 mL intramuscular injection, single dose

BIOLOGICAL

High-Dose Influenza Vaccine

0.7 mL intramuscular injection, single dose

Sponsors & Collaborators

  • Korea University Guro Hospital

    lead OTHER

Principal Investigators

  • Joon Young Song, MD, PhD · Korea University Guro Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-25
Primary Completion
2026-01-31
Completion
2026-08-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07805837 on ClinicalTrials.gov