About this trial
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.
Eligibility criteria
Qualifiers
Chinese male or female adults aged ≥ 18 years;
Participants with suspected tetanus exposure (due to dirty or contaminated wounds from various injuries);
Participants who provide signed written informed consent form.
Disqualifiers
Participants known to be allergic to the investigational medicinal product or those suffering from severe allergic conditions;
Suspect or diagnosed as tetanus;
Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies;
Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;
Trial design
Treatments tested in this trial
- GR2001
- HTIG