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The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) in combination with rabies vaccine in healthy children and adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | CL184 combined with rabies vaccination |
|
| B | Active Comparator | HRIG combined with rabies vaccination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CL184 | Biological | CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rabies virus neutralizing activity | 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beatriz P. Quiambao, MD | Research Institute for Tropical Medicine, Alabang, Muntinlupa, Metro Manila, Philippines | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute for Tropical Medicine | Alabang, Muntinlupa, Metro Manila | Philippines |
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| HRIG | Biological | HRIG 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28 |
|
| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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