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This study is designed as a randomized, open-label, parallel-design study to evaluate the effect of TNM002 simultaneously administered with adsorbed tetanus vaccine on the PK, PD and immunogenicity properties of TNM002 and on the PD properties of the adsorbed tetanus vaccine, and to evaluate the safety and tolerability of TNM002 administered alone and simultaneously administered with adsorbed tetanus vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | TNM002 |
|
| Group 2 | Active Comparator | Adsorbed tetanus vaccine |
|
| Group 3 | Experimental | TNM002 + adsorbed tetanus vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNM002 | Biological | A single intramuscular (IM) gluteal injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) of TNM002, area under the plasma concentration-time curve from time 0 to the last quantifiable time point post-dose (AUC0-last) | Up to Day 106 | |
| Percentage of subjects with an increase of serum TNM002-specific anti-tetanus neutralizing antibody titers (ΔTiters) ≥ 0.01 IU/mL from baseline at 24 hours after immunization | Up to 24 hours after administration | |
| Percentage of subjects with serum anti-tetanus antibody titers ≥ 0.1 IU/mL on 28 days after immunization | Up to 28 days after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum serum TNM002 concentration (Tmax), elimination half-life (t1/2), and if data permit, apparent clearance (CL/F) and apparent volume of distribution (Vz/F) after immunization | Up to Day 106 | |
| Percentage of subjects with anti-tetanus neutralizing antibody ΔTiters ≥ 0.01 IU/mL at post-dose time points other than 24 hours after immunization |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Jie Hou, Doctor | Peking University Care Luzhong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PKUCare Luzhong Hospital | Zibo | Shandong | 255000 | China |
Individual participant data that underlie the results reported in the article, after deidentification.
Starting 6 months and ending 5 years following article publication.
Academics who provide a methodologically sound proposal. The leading clinical site and sponsor will review the request.
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| Adsorbed tetanus vaccine |
| Biological |
A single IM deltoid injection |
|
| TNM002 + adsorbed tetanus vaccine | Biological | A single IM gluteal injection+ a single IM deltoid injection |
|
| Up to Day 106 |
| Serum TNM002-specific anti-tetanus neutralizing antibody titer and ΔTiters at each post-dose time point after immunization | Up to Day 106 |
| Percentage of subjects with anti-tetanus antibody titer ≥ 0.1 IU/mL at post-dose time points other than 28 days after immunization | Up to Day 106 |
| Percentage of subjects with serum anti-tetanus antibody titer ≥ 1.0 IU/mL at each post-dose time point after immunization | Up to Day 106 |
| Serum anti-tetanus antibody titers, and fold increases from baseline at each post-dose time point | Up to Day 106 |
| Adverse events (AEs), safety laboratory test, 12-lead electrocardiogram (ECG), physical examination, and vital signs | Up to Day 106 |
| Percentage of subjects with positive anti-TNM002 antibody (ADA) in serum. | Up to Day 106 |
| ID | Term |
|---|---|
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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