Adjuvanted vs non-adjuvanted flu vaccine in older adults with chronic conditions
A Comparative Study on the Immunogenicity and Safety of Adjuvanted Versus Non-Adjuvanted Influenza Vaccines in the Elderly
This test tries to see if an adjuvanted flu vaccine gives stronger immune protection and similar safety compared with a standard flu shot in people 65 and older who have chronic medical conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06676644 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people aged 65 or older with at least one chronic medical condition listed in the protocol who have not yet received a flu vaccine this season and have no contraindication to influenza vaccination.
Not a fit: People with a history of severe reactions to influenza vaccines, a current-season influenza vaccination, or other contraindications would not be eligible and would not receive benefit from this trial.
Why it matters
Potential benefit: If successful, the adjuvanted vaccine could provide stronger protection against influenza and reduce complications in older adults with chronic health conditions.
How similar studies have performed: Adjuvanted influenza vaccines have shown improved immune responses in older adults in prior studies and are recommended by some public health bodies, though local data in Taiwan remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Taipei
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.