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| Name | Class |
|---|---|
| inVentiv Health Clinical | OTHER |
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This is single site, randomized, blinded comparison of the immunogenicity, of Imovax (RVi) and Rabavert (RVa) rabies vaccines when subjects are administered rabies immune globulin (RIG) or SYN023. Subjects will be randomized into one of four dose groups: RVi + SYN023, RVi+RIG, RVa+SYN023 and RVa+RIG. The initial dose of RVi and RVa will be co-administered with either RIG or SYN023). Rabies virus neutralizing activity (RVNA) and blood levels of SYN023 will be measured for the remainder of the trial while the rest of the five RVi and RVa doses are given. The study will last 112 days. SYN023 concentrations and anti-SYN023 antibodies will also be measured.
Administered immunoglobulins directed against vaccine antigens have the potential to inhibit the immune response to a vaccine. Both vaccination and immune globulin are used together in the post exposure prophylaxis of rabies virus infection. SYN023 (a mixture of two monoclonal antibodies CTB011 and CTB012) may be used instead of human rabies immune globulin. Since there is a risk of antagonism of vaccine induced immunity by SYN023, as there is with rabies immune globulin, it is necessary to study possible interactions of these two agents that might be used concurrently. This is single site, randomized, blinded comparison of the immunogenicity, of Imovax (RVi) and Rabavert (RVa) rabies vaccines when administered concurrently with rabies immune globulin (RIG) or SYN023. Subjects will be randomized into one of four dose groups: RVi + SYN023, RVi + RIG, RVa+SYN023 and RVa + RIG. The initial dose of RVi and RVa will be co-administered with either RIG or SYN023). The remaining 4 doses of RVi and RVa will be administered intramuscularly as specified in the product labeling. Serum rabies virus neutralizing activity (RVNA) and serum concentrations of the components of of SYN023 will be measured for the remainder of the trial while the rest of the five RVi and RVa doses are given. Adverse events will be collected for the duration of the trial. The study will last 112 days. Anti-SYN023 antibodies will also be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imovax, SYN023 | Experimental | Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine |
|
| Imovax, human rabies immune globulin | Active Comparator | Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine |
|
| RabAvert, SYN023 | Experimental | Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine |
|
| RabAvert, human rabies immune globulin | Active Comparator | Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYN023 | Biological | The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serum Rabies Virus Neutralizing Activity | Inhibitory activity of serum in standard rabies virus inhibition test (RFFIT: Rapid Fluorescent Foci Inhibition Test) assessed as serum RVNA ≥ 0.5 IU/mL. RFFIT is a serum neutralization (inhibition) test, which means it measures the ability of rabies specific antibodies to neutralize rabies virus and prevent the virus from infecting cells. These antibodies are called rabies virus neutralizing antibodies (RVNA). | 112 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Event Incidence of SYN023 Compared to HRIG in RabAvert and Imovax Reciptients | Electrocardiograms are performed to monitor subject safety. Laboratory evaluations for subject safety (adverse events) are serum chemistry evaluations, blood urea nitrogen, creatinine, bilirubin, alanine amino transferase, aspartate amino transferase, creatine phosphokinase, troponin, potassium, sodium, bicarbonate, calcium, complete blood count, platelet count, differential count, PT(prothrombin time, international normalized ratio) and PTT (partial prothrombin time and urinalyses for monitoring of safety. Additional laboratory tests may be required for evaluation of specific adverse events such as anaphylaxis and immune complex diseases. Adverse events and serious adverse events will be analyzed. A comparison of adverse event incidence between the four treatment groups will be performed. |
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Inclusion Criteria:
Male or female subjects between 18 and 50 years of age, inclusive
Body mass index between 18 and 30 kg/m², inclusive
Female subjects physically capable of pregnancy (i.e., not sterilized and still menstruating or within 1 year of the last menses if menopausal) must:
Women of childbearing potential must have a negative serum pregnancy test within 24 hours preceding receipt of each dose.
Can understand and sign the informed consent document, can communicate with the investigator and provide updated contact information as needed for the duration of the study, has no current plans to move from the study area for the duration of the study, and can understand and comply with the requirements of the protocol.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wyatt J David, PhD | inVentiv Health Clinical Research Services LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| inVentiv Clinical Research Facility, 1951 NW 7th Ave. Suit 450 | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34483020 | Derived | McClain JB, Chuang A, Reid C, Moore SM, Tsao E. Rabies virus neutralizing activity, pharmacokinetics, and safety of the monoclonal antibody mixture SYN023 in combination with rabies vaccination: Results of a phase 2, randomized, blinded, controlled trial. Vaccine. 2021 Sep 24;39(40):5822-5830. doi: 10.1016/j.vaccine.2021.08.066. Epub 2021 Sep 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Imovax, SYN023 | Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin. Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine |
| FG001 | Imovax, Human Rabies Immune Globulin | Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin. Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine |
| FG002 | RabAvert, SYN023 | Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin. Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine |
| FG003 | RabAvert, Human Rabies Immune Globulin | Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin. Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Imovax, SYN023 | Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin. Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Participants With Serum Rabies Virus Neutralizing Activity | Inhibitory activity of serum in standard rabies virus inhibition test (RFFIT: Rapid Fluorescent Foci Inhibition Test) assessed as serum RVNA ≥ 0.5 IU/mL. RFFIT is a serum neutralization (inhibition) test, which means it measures the ability of rabies specific antibodies to neutralize rabies virus and prevent the virus from infecting cells. These antibodies are called rabies virus neutralizing antibodies (RVNA). | Per-Protocol Population (subject with complete RVNA data). | Posted | Number | percentage of participants | 112 days |
|
112 days
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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) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Imovax, Human Rabies Immune Globulin | Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin. Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Troponin I increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA (20.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Synermore Biologics Co., Ltd. | +886 2 2659 0988 | achuang@synermore.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 18, 2017 | Nov 15, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 21, 2016 | Nov 16, 2018 | Prot_001.pdf |
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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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| Imovax | Biological | Subjects will receive SYN023 or HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine |
|
| RabAvert | Biological | Subjects will receive SYN023 or HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine |
|
| HyperRAB ST (human rabies immune globulin) | Biological | The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin. |
|
| 42 days |
| Percentage of Participants With Immunogenicity: Anti-CTB012 Antibodies Positive | Measurement of the development of anti-CTB012 antibodies (a component of anti-SYN023 antibodies) in participants which will be analyzed on a continuous scale as a categorical variable by treatment assignment, with descriptive statistics. | 112 days |
| Percentage of Participants With Immunogenicity: Anti-CTB011 Antibodies Positive | Measurement of the development of anti-CTB011 antibodies (a component of anti-SYN023 antibodies) in participants which will be analyzed on a continuous scale as a categorical variable by treatment assignment, with descriptive statistics. | 112 days |
| SYN023 Monoclonal Antibody Areas Under the Curve (AUC0-last, AUC0-inf) for CTB011 and CTB012) | The area under the time concentration curve for SYN023 mAb components CTB011 and CTB012 will be estimated at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis. | 84 days |
| Time to Maximum Concentration Tmax of CTB011 and CTB012 | Interval from time 0 to maximum measured concentration of CTB011 and CTB012 (SYN023 components) at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis. | 84 days |
| Maximum Serum Concentration Cmax | Maximum concentration of of CTB011 and CTB012 at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis. | 84 days |
| Serum Clearance Rate (Clp) of CTB011 and CTB012 | Calculated serum clearance rates for CTB011 and CTB012 at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis. | 84 days |
| Serum Half Lives of CTB011 and CTB012 | The time in hours to reduce the serum concnetration of CTB011 and CTB012 to 50% of the maximum serum concentration at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis. | 84 days |
| BG001 | Imovax, Human Rabies Immune Globulin | Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin. Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine |
| BG002 | RabAvert, SYN023 | Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin. Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine |
| BG003 | RabAvert, Human Rabies Immune Globulin | Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin. Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Imovax, Human Rabies Immune Globulin | Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin. Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine |
| OG002 | RabAvert, SYN023 | Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin. Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine |
| OG003 | RabAvert, Human Rabies Immune Globulin | Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin. Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine |
|
|
|
| Secondary | Percentage of Participants With Adverse Event Incidence of SYN023 Compared to HRIG in RabAvert and Imovax Reciptients | Electrocardiograms are performed to monitor subject safety. Laboratory evaluations for subject safety (adverse events) are serum chemistry evaluations, blood urea nitrogen, creatinine, bilirubin, alanine amino transferase, aspartate amino transferase, creatine phosphokinase, troponin, potassium, sodium, bicarbonate, calcium, complete blood count, platelet count, differential count, PT(prothrombin time, international normalized ratio) and PTT (partial prothrombin time and urinalyses for monitoring of safety. Additional laboratory tests may be required for evaluation of specific adverse events such as anaphylaxis and immune complex diseases. Adverse events and serious adverse events will be analyzed. A comparison of adverse event incidence between the four treatment groups will be performed. | Posted | Number | percentage of participants | 42 days |
|
|
|
| Secondary | Percentage of Participants With Immunogenicity: Anti-CTB012 Antibodies Positive | Measurement of the development of anti-CTB012 antibodies (a component of anti-SYN023 antibodies) in participants which will be analyzed on a continuous scale as a categorical variable by treatment assignment, with descriptive statistics. | Subjects at least 1 initial anti-SYN023 assay results | Posted | Number | percentage of participants | 112 days |
|
|
|
| Secondary | Percentage of Participants With Immunogenicity: Anti-CTB011 Antibodies Positive | Measurement of the development of anti-CTB011 antibodies (a component of anti-SYN023 antibodies) in participants which will be analyzed on a continuous scale as a categorical variable by treatment assignment, with descriptive statistics. | Subjects at least 1 initial anti-SYN023 assay results | Posted | Number | percentage of subjects | 112 days |
|
|
|
| Secondary | SYN023 Monoclonal Antibody Areas Under the Curve (AUC0-last, AUC0-inf) for CTB011 and CTB012) | The area under the time concentration curve for SYN023 mAb components CTB011 and CTB012 will be estimated at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis. | Per-Protocol Population (subjects who received all scheduled doses of a study treatment and remained on study for at least 28 days without major protocol violation) | Posted | Mean | Standard Deviation | day*ng/mL | 84 days |
|
|
|
| Secondary | Time to Maximum Concentration Tmax of CTB011 and CTB012 | Interval from time 0 to maximum measured concentration of CTB011 and CTB012 (SYN023 components) at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis. | Per-Protocol Population (subjects who received all scheduled doses of a study treatment and remained on study for at least 28 days without major protocol violation). No detectable and quantifiable levels of CTB011 and CTB012 were observed in human rabies immune globulin groups, so no PK or statistical analysis was planned. | Posted | Mean | Standard Deviation | day | 84 days |
|
|
|
| Secondary | Maximum Serum Concentration Cmax | Maximum concentration of of CTB011 and CTB012 at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis. | Per-Protocol Population (subjects who received all scheduled doses of a study treatment and remained on study for at least 28 days without major protocol violation). No detectable and quantifiable levels of CTB011 and CTB012 were observed in human rabies immune globulin groups, so no PK or statistical analysis was planned. | Posted | Mean | Standard Deviation | ng/mL | 84 days |
|
|
|
| Secondary | Serum Clearance Rate (Clp) of CTB011 and CTB012 | Calculated serum clearance rates for CTB011 and CTB012 at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis. | Per-Protocol Population (subjects who received all scheduled doses of a study treatment and remained on study for at least 28 days without major protocol violation). No detectable and quantifiable levels of CTB011 and CTB012 were observed in human rabies immune globulin groups, so no PK or statistical analysis was planned. | Posted | Mean | Standard Deviation | L/day | 84 days |
|
|
|
| Secondary | Serum Half Lives of CTB011 and CTB012 | The time in hours to reduce the serum concnetration of CTB011 and CTB012 to 50% of the maximum serum concentration at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis. | Per-Protocol Population (subjects who received all scheduled doses of a study treatment and remained on study for at least 28 days without major protocol violation). No detectable and quantifiable levels of CTB011 and CTB012 were observed in human rabies immune globulin groups, so no PK or statistical analysis was planned. | Posted | Mean | Standard Deviation | day | 84 days |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 20 |
| 40 |
| EG001 | RabAvert, Human Rabies Immune Globulin | Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin. Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine | 0 | 42 | 0 | 42 | 25 | 42 |
| EG002 | Imovax, SYN023 | Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin. Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine | 0 | 40 | 0 | 40 | 24 | 40 |
| EG003 | RabAvert, SYN023 | Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin. Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine | 0 | 42 | 1 | 42 | 31 | 42 |
| Influenza like illness | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Injection site bruising | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Catheter site haemorrhage | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Vessel puncture site haemorrhage | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Energy increased | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Injection site inflammation | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Bacterial test positive | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Crystal urine present | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Urine leukocyte esterase positive | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Muscle contusion | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (20.0) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (20.0) | Systematic Assessment |
|
Not provided
Not provided
| Solicited AEs |
|
| AUC0-t for CTB-012 |
|
| AUC0-inf for CTB-012 |
|