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| Name | Class |
|---|---|
| Guizhou Center for Disease Control and Prevention | OTHER |
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This study is a randomized, double-blind, active-controlled design. The goal is to evaluate the safety, pharmacokinetics and pharmacodynamic of SYN023 in combination with rabies vaccine in healthy participants under 18 years of age.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose SYN023 combined with rabies vaccine | Experimental | A single intramuscular injection of SYN023 at low dose combined with the Chinese licensed Vero Cell Rabies Vaccine (Essen 5-dose regimen) |
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| High-dose SYN023 combined with rabies vaccine | Experimental | A single intramuscular injection of SYN023 at high dose combined with the Chinese licensed Vero Cell Rabies Vaccine (Essen 5-dose regimen) |
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| HRIG combined with rabies vaccine | Active Comparator | A single intramuscular injection of Human rabies immunoglobulin (HRIG)combined with the Chinese licensed Vero Cell Rabies Vaccine (Essen 5-dose regimen) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYN023 | Biological | SYN023 should be administered intramuscularly at sites distant from the vaccine injection site, either at the gluteus maximus or vastus lateralis muscles. The investigator should determine appropriate injection sites for multiple-point administration based on the participant's age and body weight. It is recommended that not more than 6 mL be administered per single gluteus maximus or vastus lateralis muscle, with not more than 4 mL per single injection site (younger children may require reduced volumes per muscle and per injection site based on individual circumstances); Injection time: Day 0. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse drug reactions (ADRs) and adverse events (AEs) | 42 days | |
| Incidence of serious adverse events (SAEs) | 126 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions and adverse events | 30 minutes and 7 days | |
| Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) | Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuping Dong Autonomous County Center for Disease Control and Prevention | Tongren | Guizhou | 554000 | China |
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| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D011819 | Rabies Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Rabies Vaccine | Biological | Dosage and administration of Rabies vaccine for human use: 0.5 mL, intramuscular injection in the deltoid muscle; Injection time: Days 0, 3, 7, 14, and 28 (Essen 5-dose regimen). |
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| HRIG | Biological | HRIG should be administered intramuscularly at sites distant from the vaccine injection site, either in the gluteus maximus or vastus lateralis muscles. The investigator should determine appropriate injection sites for multiple-point administration based on the participant's age and body weight. It is recommended that not more than 6 mL be administered per single gluteus maximus or vastus lateralis muscle, with not more than 4 mL per single injection site (younger children may require reduced volumes per muscle and per injection site based on individual circumstances); Injection time: Day 0. |
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| Days 3, 7, 14, 42, 98 and 126 |
| Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL | Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT). | Days 3, 7, 14, 42, 98 and 126 |
| Area Under the Efficacy Curve for the Geometric Mean Concentration (GMC) of Rabies Virus Neutralizing Activity (RVNA) | Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT). Area Under the Efficacy Curve for the GMC of RVNA from Study Day 0 to Day 14 after administration (AUEC0-14) | Day 0 to Day 14 |
| Maximum serum concentration (Cmax) | Cmax for SYN023 mAb components CTB011 and CTB012 will be estimated at Day 0 (pre-dose), Day 3, Day 7, Day 14, Day 42, Day 98 and Day 126 post-dose, using non compartmental analysis. | 126 days |
| Time to maximum concentration (Tmax) | Tmax for SYN023 mAb components CTB011 and CTB012 will be estimated at Day 0 (pre-dose), Day 3, Day 7, Day 14, Day 42, Day 98 and Day 126 post-dose, using non compartmental analysis. | 126 days |
| Area under the concentration-time curve (AUC0-t and AUC0-∞) | AUC0-t and AUC0-∞ for SYN023 mAb components CTB011 and CTB012 will be estimated at Day 0 (pre-dose), Day 3, Day 7, Day 14, Day 42, Day 98 and Day 126 post-dose, using non compartmental analysis. | 126 days |
| Terminal half-life (t1/2) | t1/2 for SYN023 mAb components CTB011 and CTB012 will be estimated at Day 0 (pre-dose), Day 3, Day 7, Day 14, Day 42, Day 98 and Day 126 post-dose, using non compartmental analysis. | 126 days |
| D007239 | Infections |