adjuvanted: adjuvanted (aIIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions
non-adjuvanted: non-adjuvanted (IIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions
Study summary
To compare the immunogenicity, cellular immune response, and safety between adjuvanted (aIIV4) and non-adjuvanted (IIV4) seasonal influenza vaccines in the Taiwanese elderly population with chronic medical conditions.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
The seroconversion rate (SCR) measured by the change in hemagglutination inhibition (HI) titer against the vaccine strains in serum between Day 1 (pre-vaccination) and Day 29. — Measured through Day 29 The seroconversion rate (SCR) measured by the change in hemagglutination inhibition (HI) titer against the vaccine strains in serum between Day 1 (pre-vaccination) and Day 29.
Trial sites (1)
Facility
City
Region
Status
National Taiwan University Hospital
Taipei
Taiwan
Recruiting
More National Taiwan University Hospital trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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