The primary objective of this clinical trial is to compare the efficacy and safety of SNA02-48 injection with Human Tetanus Immunoglobulin (HTIG) for tetanus prophylaxis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
600
IM gluteal injection
IM gluteal injection
The proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.
Time frame: Baseline up to 12 hours after receipt of study drug
The incidence of tetanus
Time frame: Up to 105 days after receipt of study drug
anti-tetanus neutralizing antibody titers
Time frame: Up to 90 days after receipt of study drug
Incidence of adverse events
Time frame: Up to 105 days after receipt of study drug
Incidence of severe adverse events (SAEs)
Time frame: Up to 105 days after receipt of study drug
To evaluate the plasma concentration of SNA02-48
Time frame: Up to 90 days after receipt of study drug
Incidence of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Time frame: Up to 90 days after receipt of study drug
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Taihe County People's Hospital
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Peking University First Hospital
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The Third Affiliated Hospital of Guangzhou Medical University
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Guangzhou Eighth People's Hospital, Guangzhou Medical University
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...and 20 more locations