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The primary objective is to compare the anti-tetanus neutralizing antibody titers of TNM002 Injection with human tetanus immunoglobulin (HTIG) following a single intramuscular (IM) injection in Chinese adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNM002 low dose | Experimental | Participants receive a single intramuscular injection of TNM002 with low dose on Day 1 |
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| TNM002 medium dose | Experimental | Participants receive a single intramuscular injection of TNM002 with medium dose on Day 1 |
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| TNM002 high dose | Experimental | Participants receive a single intramuscular injection of TNM002 with high dose on Day 1 |
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| Human Tetanus Immunoglobulin (HTIG) | Active Comparator | Participants receive a single intramuscular injection of human tetanus immunoglobulin 250 IU on Day 1 |
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| Placebo | Placebo Comparator | Participants receive a single intramuscular injection of placebo on Day 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNM002 (low dose) | Biological | Single dose of TNM002 administered by intramuscular injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters >0.01 IU/mL. | At 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters >0.01 IU/mL. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Hou | Peking University Care Luzhong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shantou University Medical College | Shantou | Guangdong | China | |||
| Wuxi People's Hospital |
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There were 402 participants excluded from the trial before assignment to any arm, primarily due to failure to meet eligibility criteria (369 participants) and other (33).
A total of 240 adult participants were recruited from 4 study sites in China, from 18 April 2022 to 27 May 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | TNM002 5 mg | Double blind, a single intramuscular injection on Day 1 |
| FG001 | TNM002 10 mg | Double blind, a single intramuscular injection on Day 1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2022 |
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| TNM002 (medium dose) | Biological | Single dose of TNM002 administered by intramuscular injection |
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| TNM002 (high dose) | Biological | Single dose of TNM002 administered by intramuscular injection |
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| HTIG | Biological | Single dose of HTIG administered by intramuscular injection |
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| Placebo | Biological | Single dose of placebo administered by intramuscular injection |
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| At 24 hours, 48 hours, and on Days 3, 7, 21, 30 and 90 post-dose |
| Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters >0.01 IU/mL. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint. | At 48 hours and on Days 3, 7, 21, 30, and 90 post-dose |
| Duration of Anti-tetanus Neutralizing Antibody Titers Increasing From Baseline Over Protective Level Post-dose | The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters >0.01 IU/mL. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint. | Up to 105 (±7) days post dosing |
| Maximum Concentration (Cmax) of TNM002 | The peak serum concentration of TNM002 observed after administration. | Up to 105 days post dosing |
| Time to Maximum Concentration (Tmax) of TNM002 | The time point at which the Cmax is observed following TNM002 administration. | Up to 105 days post dosing |
| Elimination Half-life (t1/2) of TNM002 | The time required for the serum concentration of TNM002 to decrease by 50% during the elimination phase. | Up to 105 days post dosing |
| Area Under the Concentration-time Curve From Time 0 to t (AUC0-t) of TNM002 | The total drug exposure of TNM002 over a defined time period (from administration to the last measurable concentration), calculated as the integral of the serum concentration-time curve. | Up to 105 days post dosing |
| Area Under the Concentration-time Curve From Time 0 to ∞ (AUC0-∞) of TNM002 | The total systemic exposure of TNM002 from administration until complete elimination, calculated by combining AUC0-t and the extrapolated area from the last measurable concentration to infinity. | Up to 105 days post dosing |
| Positive Rate of ADA in Volunteers in TNM002 Groups | The proportion of participants who developed anti-drug antibodies (ADA) against TNM002 during the course of the trial. | Up to 105 days post dosing |
| Wuxi |
| Jiangsu |
| China |
| PKUCare Luzhong Hospital | Zibo | Shandong | China |
| Yunnan Provincial Hospital of Traditional Chinese Medicine | Kunming | Yunnan | China |
| FG002 | TNM002 15 mg | Double blind, a single intramuscular injection on Day 1 |
| FG003 | HTIG | Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1 |
| FG004 | Placebo | Double blind, a single intramuscular injection on Day 1 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TNM002 5 mg | Double blind, a single intramuscular injection on Day 1 |
| BG001 | TNM002 10 mg | Double blind, a single intramuscular injection on Day 1 |
| BG002 | TNM002 15 mg | Double blind, a single intramuscular injection on Day 1 |
| BG003 | HTIG | Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1 |
| BG004 | Placebo | Double blind, a single intramuscular injection on Day 1 |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years of age |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Anti-tetanus neutralizing antibody titers | The administration of placebo precluded measurable antibody response generation, thus participants in the placebo group were excluded from the efficacy analyses regarding the changes in antibody titers. Baseline antibody titers were measured for placebo participants solely for demographic balance assessment and assay validation purposes. | Geometric Mean | Standard Deviation | IU/mL |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters >0.01 IU/mL. | The analysis plan prespecified that placebo group data would not be collected for this outcome measure related to the anti-tetanus antibody level, as the administration of placebo precludes the generation of measurable antibody responses. Therefore, placebo recipients were analytically excluded from the efficacy analysis of antibody titer changes. The active control (HTIG) serves as the comparator for efficacy assessments, while the placebo group is retained solely for safety evaluations. | Posted | Count of Participants | Participants | At 24 hours post-dose |
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| Secondary | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters >0.01 IU/mL. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint. | The analysis plan prespecified that placebo group data would not be collected for this outcome measure related to the anti-tetanus antibody level, as the administration of placebo precludes the generation of measurable antibody responses. Therefore, placebo recipients were analytically excluded from the efficacy analysis of antibody titer changes. The active control (HTIG) serves as the comparator for efficacy assessments, while the placebo group is retained solely for safety evaluations. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At 24 hours, 48 hours, and on Days 3, 7, 21, 30 and 90 post-dose |
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| Secondary | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters >0.01 IU/mL. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint. | The analysis plan prespecified that placebo group data would not be collected for this outcome measure related to the anti-tetanus antibody level, as the administration of placebo precludes the generation of measurable antibody responses. Therefore, placebo recipients were analytically excluded from the efficacy analysis of antibody titer changes. The active control (HTIG) serves as the comparator for efficacy assessments, while the placebo group is retained solely for safety evaluations. | Posted | Count of Participants | Participants | At 48 hours and on Days 3, 7, 21, 30, and 90 post-dose |
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| Secondary | Duration of Anti-tetanus Neutralizing Antibody Titers Increasing From Baseline Over Protective Level Post-dose | The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters >0.01 IU/mL. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint. | The analysis plan prespecified that placebo group data would not be collected for this outcome measure related to the anti-tetanus antibody level, as the administration of placebo precludes the generation of measurable antibody responses. Therefore, placebo recipients were analytically excluded from the efficacy analysis of antibody titer changes. The active control (HTIG) serves as the comparator for efficacy assessments, while the placebo group is retained solely for safety evaluations. | Posted | Median | Full Range | Day | Up to 105 (±7) days post dosing |
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| Secondary | Maximum Concentration (Cmax) of TNM002 | The peak serum concentration of TNM002 observed after administration. | All TNM002-treated participants had evaluable post-dose concentration data for the calculation of Cmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Up to 105 days post dosing |
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| Secondary | Time to Maximum Concentration (Tmax) of TNM002 | The time point at which the Cmax is observed following TNM002 administration. | All TNM002-treated participants had evaluable post-dose concentration data for the calculation of Tmax. | Posted | Median | Full Range | hours | Up to 105 days post dosing |
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| Secondary | Elimination Half-life (t1/2) of TNM002 | The time required for the serum concentration of TNM002 to decrease by 50% during the elimination phase. | Five participants were exlucded from the analysis due to model fitting failure for t1/2. | Posted | Median | Full Range | hours | Up to 105 days post dosing |
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| Secondary | Area Under the Concentration-time Curve From Time 0 to t (AUC0-t) of TNM002 | The total drug exposure of TNM002 over a defined time period (from administration to the last measurable concentration), calculated as the integral of the serum concentration-time curve. | All TNM002-treated participants had evaluable post-dose concentration data for AUC analysis. | Posted | Mean | Standard Deviation | h*ng/mL | Up to 105 days post dosing |
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| Secondary | Area Under the Concentration-time Curve From Time 0 to ∞ (AUC0-∞) of TNM002 | The total systemic exposure of TNM002 from administration until complete elimination, calculated by combining AUC0-t and the extrapolated area from the last measurable concentration to infinity. | Five participants were exlucded from the analysis due to model fitting failure for AUC0-∞. | Posted | Mean | Standard Deviation | h*ng/mL | Up to 105 days post dosing |
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| Secondary | Positive Rate of ADA in Volunteers in TNM002 Groups | The proportion of participants who developed anti-drug antibodies (ADA) against TNM002 during the course of the trial. | All TNM002-treated participants had evaluable post-dose immunogenicity data for the ADA analysis. | Posted | Count of Participants | Participants | Up to 105 days post dosing |
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From enrollment until end of follow-up, up to 105 (±7) days post dosing
The definition of adverse events in this trial is consistent with that specified in ClinicalTrials.gov.
The causality assessment in this trial utilized a dichotomous classification: "Related" or "Not Related." For an adverse event of varying severity levels occurring in the same participant, the highest severity grade observed for that AE was used for analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | TNM002 5 mg | Double blind, a single intramuscular injection on Day 1 | 0 | 61 | 0 | 61 | 30 | 61 |
| EG001 | TNM002 10 mg | Double blind, a single intramuscular injection on Day 1 | 0 | 61 | 0 | 61 | 29 | 61 |
| EG002 | TNM002 15 mg | Double blind, a single intramuscular injection on Day 1 | 0 | 29 | 0 | 29 | 14 | 29 |
| EG003 | HTIG | Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1 | 0 | 59 | 1 | 59 | 32 | 59 |
| EG004 | Placebo | Double blind, a single intramuscular injection on Day 1 | 0 | 30 | 0 | 30 | 16 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Subdural hemorrhage | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Blood triglycerides increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Alanine aminotransferase | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Bilirubin conjugated increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Monocyte count increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Red blood cells urine positive | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Neutrophil count increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Lymphocyte count increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Thrombocyte count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Blood magnesium decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Leukocytes urine positive | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Blood glucose decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wenxi Xiang | Zhuhai Trinomab Pharmaceutical Co., Ltd. | 18083065921 | xiangwenxi@trinomab.com |
| May 27, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
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| D013742 | Tetanus |
| ID | Term |
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| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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Double blind, a single intramuscular injection on Day 1
| OG003 | HTIG | Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1 |
| OG004 | Placebo | Double blind, a single intramuscular injection on Day 1 |
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Double blind, a single intramuscular injection on Day 1 |
| OG003 | HTIG | Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1 |
| OG004 | Placebo | Double blind, a single intramuscular injection on Day 1 |
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Double blind, a single intramuscular injection on Day 1
| OG003 | HTIG | Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1 |
| OG004 | Placebo | Double blind, a single intramuscular injection on Day 1 |
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