A Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection

ConditionTetanus
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenrix (Shanghai) Biopharmaceutical Co., Ltd.

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

Treatment groups

582 Participants
are divided into 2 treatment groups