Actively Recruiting
A Comparative Study on the Immunogenicity and Safety of Adjuvanted Versus Non-Adjuvanted Influenza Vaccines in the Elderly
Led by National Taiwan University Hospital · Updated on 2026-02-24
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the immune response, safety, and overall effects of two types of seasonal influenza vaccines in elderly Taiwanese people with chronic health conditions. The study compares an adjuvanted influenza vaccine (aIIV4) with a non-adjuvanted influenza vaccine (IIV4). This research aims to provide local data on vaccine safety and effectiveness, as current evidence suggests adjuvanted vaccines may better protect older adults who often have weakened immune responses. Participants will be randomly assigned to receive either the adjuvanted or non-adjuvanted vaccine. The study lasts one year and monitors immune responses and safety after vaccination. Key focus is on measuring antibody changes 29 days post-vaccination and following participants up to 361 days to assess immune protection, adverse reactions, and flu infection rates. During the study, participants will have blood samples taken before vaccination, around Day 29, and at Days 181 and 361 to evaluate immune responses. Researchers will track any severe side effects within 28 days after vaccination and monitor flu-related emergency visits, hospitalizations, and overall health during the year. The main measure is the rate at which participants develop protective antibodies by Day 29.
CONDITIONS
Brief Title
Estimate the Safety and Effectiveness of Adjuvanted Influenza Vaccine Among Asian Elderly People When Compared to Non-adjuvanted Vaccines
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 65 years or above
- Have at least one chronic medical condition that increases risk of complicated influenza, such as hypertension, chronic obstructive pulmonary disease (group A, B, E), asthma, congestive heart failure (ACC/AHA stage A, B, C, D), coronary artery disease, diabetes mellitus, chronic liver disease (Child-Pugh score A, B, C), chronic kidney disease (stage 1 to 4), neuromuscular disorders, hematological or solid organ cancer, or have received hematopoietic stem cell or solid organ transplantation
You will not qualify if you...
- History of severe allergic reaction to influenza vaccination, including anaphylaxis or Guillain-Barré Syndrome
- Severe bleeding tendency
- Received influenza vaccination during the current flu season
- Considered ineligible by the principal investigator based on clinical assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive either the adjuvanted or non-adjuvanted influenza vaccine as part of the study intervention.
1 vaccination visit (in-person)
Duration - Up to 1 year
Participants are monitored for safety and effectiveness outcomes, including immune response and incidence of influenza, through the course of one year.
Visits on Day 1 (baseline), Day 29, Day 181, and Day 361 (in-person visits)
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
Research Team
J
Jann-Tay Wang Clinical Professor, M. D., Ph.D.
U
Un-In Wu Clinical Associate Professor, M. D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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