The goal of this clinical trial is to compare the efficacy and safety of GR2001 injection with Human Tetanus Immunoglobulin(HTIG) in tetanus prophylaxis. Patients will receive either GR2001 injection or HTIG on study D0.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
582
The packaging for GR2001 injection uses a borosilicate glass vial, a brominated halobutyl rubber stopper for injectable solutions and an aluminum-plastic combination cap for antibiotic vials as its primary packaging materials. The specification is 5mg/1ml per vial.
The HTIG is a Chinese licensed Human Tetanus Immunoglobulin produced by Tonglu-Bio, which are derived from human plasma, and then purified and filled in the injectable vial form.
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The increase of anti-tetanus neutralizing antibody titers (∆ titers)
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 Investigational medicinal product.
The incidence of tetanus
Time frame: Up to 105 days after receipt of Investigational medicinal product.
To evaluate the safety of GR2001
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Time frame: Up to 105 days after receipt of Investigational medicinal product.
To evaluate the peak plasma concentration(Cmax) of GR2001
Time frame: Up to 105 days after receipt of Investigational medicinal product.
To evaluate the Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR2001
Time frame: Up to 105 days after receipt of Investigational medicinal product.
To evaluate the immunogenicity of GR2001
Time frame: Up to 105 days after receipt of Investigational medicinal product.
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