The objective of this study was to evaluate the safety of quadrivalent subunit influenza vaccine (adjuvant) in people aged 65 years and older.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
80
A single 0.25 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0.
A single 0.5 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0.
A single 0.5 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0
Yunxi County Center for Disease Control and Prevention
Shiyan, Hubei, China
Incidence of adverse events (AEs) or reactions (ARs) within 30 minutes post-vaccination
Time frame: Within 30 minutes post-vaccination
Incidence of adverse events (AEs) or reactions (ARs) within 0-7 days post-vaccination
Time frame: Within 0-7 days post-vaccination
Incidence of adverse events (AEs) or reactions (ARs) within 0-28 days post-vaccination
Time frame: Within 0-28 days post-vaccination
The incidence of laboratory abnormalities (including blood biochemistry, blood routine and urine routine ) on Day 3 post-vaccination.
Time frame: On Day 3 post-vaccination
The incidence of serious adverse events (SAEs) and Adverse Events of Special Interest (AESI) within 12 months post-vaccination.
Time frame: Within 12 months post-vaccination.
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A single 0.5 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0.