The primary objective of the study was to investigate the safety and tolerability of CAIV-T liquid formulation in healthy Japanese male adults.
The primary objective of the study was to investigate the safety and tolerability of CAIV-T liquid formulation in healthy Japanese male adults by evaluating the incidence of influenza-like symptoms, and the type, incidence, and severity of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
45
The number of subjects within each treatment arm who experienced influenza-like symptoms
Influenza-like symptoms, ie, typical clinical symptoms of influenza infection, including fever (oral temperature \> or = 38 degrees C), cough, runny or stuffy nose, sore throat, headache, chills, muscular pain, vomiting, decline in activity, decline in appetite.
Time frame: Within 6 days post vaccination
The number of subjects within each treatment arm who experienced adverse events
Adverse events were classified according to the "Glossary of Side Effects of Pharmaceutical Agents, 1996."
Time frame: Within 28 days of vaccination
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