Adjuvanted vs non-adjuvanted flu vaccine in older adults with chronic conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a one-year randomized controlled trial at National Taiwan University Hospital comparing an adjuvanted quadrivalent influenza vaccine (aIIV4) with a non-adjuvanted quadrivalent vaccine (IIV4) in Taiwanese adults aged 65 and older with chronic conditions. The trial measures humoral immunogenicity, cellular immune responses, and records safety and adverse events following vaccination. Key eligibility requires age 65+ with at least one chronic medical condition and excludes those with contraindications or prior influenza vaccination in the current season. Participants receive a single season vaccine and are followed through the influenza season for immune response and safety outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 65 years or above
* Presence of at least 1 chronic medical condition associated with increased risk of complicated influenza, including hypertension, chronic obstructive pulmonary disease (group A, B, E), asthma, congestive heart failure (ACC/AHA stage A, B, C, D), coronary arterial disease, diabetes mellitus, chronic liver disease (Child-Pugh score A, B, C) or chronic kidney disease (stage 1\~4), neuromuscular disorders, hematological or solid organ malignancies, recipient of hematopoietic stem cell transplantation or solid organ transplantation.

Exclusion Criteria:

* Contraindications to influenza vaccination including history of severe adverse event after vaccination, such as anaphylaxis or Guillain-Barré Syndrome, or a severe bleeding tendency
* Prior receipt of influenza vaccination during the current flu season.
* Determination by the Principal Investigator (PI) that the participant is ineligible for enrollment based on clinical assessment.

Where it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Jann-Tay Wang Clinical Professor, M. D., Ph.D.
• Email: wangjt1124@ntuh.gov.tw
• Phone: +886-2-2312-3456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.