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.
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.
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.
Parallel
adjuvanted
Drugadjuvanted (aIIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions
non-adjuvanted
Drugnon-adjuvanted (IIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions
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.
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.
The geometric mean titer (GMT), seroprotection rate (SPR), cellular immune responses on Day1, Day 29 (±3), Day 181 (±7), and Day 361 (±7)
The geometric mean titer (GMT), seroprotection rate (SPR), cellular immune responses on Day1, Day 29 (±3), Day 181 (±7), and Day 361 (±7)
Incidence of severe adverse reactions within 28 days after immunization.
Incidence of severe adverse reactions within 28 days after immunization.
Incidence of laboratory-confirmed influenza during the study period.
Incidence of laboratory-confirmed influenza during the study period.
Incidence of emergency department visits and hospitalizations related to respiratory illness, all-cause mortality during the study period.
Incidence of emergency department visits and hospitalizations related to respiratory illness, all-cause mortality during the study period.
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