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

Genrix (Shanghai) Biopharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Tetanus

Treatments: Biological: GR2001; Biological: HTIG

Study type: Interventional

Funder types: Industry

Identifiers

NCT06635798

GR2001-002

Details and patient eligibility

About

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.

Enrollment: 582 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Chinese male or female adults aged ≥ 18 years；
2. Participants with suspected tetanus exposure (due to dirty or contaminated wounds from various injuries);
3. Participants who provide signed written informed consent form.

Exclusion criteria

1. Participants known to be allergic to the investigational medicinal product or those suffering from severe allergic conditions；
2. Suspect or diagnosed as tetanus;
3. Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies；
4. Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;
5. Females who are pregnant or with pregnancy test positive.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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582 participants in 2 patient groups

GR2001

Experimental group

Description:

If randomized to GR2001, participant will receive a single IM gluteal injection of GR2001

Treatment:

Biological: GR2001

HTIG

Active Comparator group

Description:

If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG

Treatment:

Biological: HTIG