Estimate the Safety and Effectiveness of Adjuvanted Influenza Vaccine Among Asian Elderly People When Compared to Non-adjuvanted Vaccines
A Comparative Study on the Immunogenicity and Safety of Adjuvanted Versus Non-Adjuvanted Influenza Vaccines in the Elderly
National Taiwan University Hospital
200 participants
Nov 21, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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 Criteria3
- 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.
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Interventions
adjuvanted (aIIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions
non-adjuvanted (IIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions
Locations(1)
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NCT06676644