A Phase 1/2 interventional study of SYN023 and Imovax in Human Rabies, sponsored by Synermore Biologics Co., Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by Synermore Biologics Co., Ltd. · Phase 1/2, Interventional, and Prevention
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.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's enrollment of 164 is below the median of 201 across 104 interventional studies indexed under Rabies.
Browse Rabies studies →Synermore Biologics Co., Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female subjects physically capable of pregnancy (i.e., not sterilized and still menstruating or within 1 year of the last menses if menopausal) must:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine
Biological: SYN023 · Biological: Imovax
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
Biological: Imovax · Biological: HyperRAB ST (human rabies immune globulin)
Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine
Biological: SYN023 · Biological: RabAvert
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
Biological: RabAvert · Biological: HyperRAB ST (human rabies immune globulin)
The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Subjects will receive SYN023 or HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
Subjects will receive SYN023 or HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
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).
Time frame: 112 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 84 days
| Milestone | Imovax, SYN023 | Imovax, Human Rabies Immune Globulin | RabAvert, SYN023 | RabAvert, Human Rabies Immune Globulin |
|---|---|---|---|---|
| Started | 40 | 40 | 42 | 42 |
| Completed | 38 | 37 | 36 | 38 |
| Not completed | 2 | 3 | 6 | 4 |
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).
| percentage of participants | Imovax, SYN023 | Imovax, Human Rabies Immune Globulin | RabAvert, SYN023 | RabAvert, Human Rabies Immune Globulin |
|---|---|---|---|---|
| Percentage of Participants With Serum Rabies Virus Neutralizing Activity | 94.3 | 97.1 | 97.1 | 100 |
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.
| percentage of participants | Imovax, SYN023 | Imovax, Human Rabies Immune Globulin | RabAvert, SYN023 | RabAvert, Human Rabies Immune Globulin |
|---|---|---|---|---|
| Unsolicited AEs | 60 | 50 | 73.8 | 59.5 |
| Solicited AEs | 15 | 47.5 | 28.6 | 40.5 |
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.
| percentage of participants | Imovax, SYN023 | Imovax, Human Rabies Immune Globulin | RabAvert, SYN023 | RabAvert, Human Rabies Immune Globulin |
|---|---|---|---|---|
| Percentage of Participants With Immunogenicity: Anti-CTB012 Antibodies Positive | 5.3 | 0 | 0 | 3.6 |
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.
| percentage of subjects | Imovax, SYN023 | Imovax, Human Rabies Immune Globulin | RabAvert, SYN023 | RabAvert, Human Rabies Immune Globulin |
|---|---|---|---|---|
| Percentage of Participants With Immunogenicity: Anti-CTB011 Antibodies Positive | 36.8 | 28.6 | 31.4 | 21.4 |
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.
| day*ng/mL | Imovax, SYN023 | RabAvert, SYN023 |
|---|---|---|
| AUC0-t for CTB-011 | 17549.49 ± 8300.05 | 17318.95 ± 7488.84 |
| AUC0-inf for CTB-011 | 20604.56 ± 8904.60 | 20924.6 ± 7041.56 |
| AUC0-t for CTB-012 | 22896.71 ± 113653.68 | 23617.93 ± 10768.7 |
| AUC0-inf for CTB-012 | 30943.29 ± 11230.39 | 32495.98 ± 11892.98 |
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.
| day | Imovax, SYN023 | RabAvert, SYN023 |
|---|---|---|
| Tmax for CTB-011 | 6.655 ± 5.957 | 6.686 ± 4.741 |
| Tmax for CTB-012 | 6.892 ± 6.316 | 6.932 ± 4.417 |
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.
| ng/mL | Imovax, SYN023 | RabAvert, SYN023 |
|---|---|---|
| Cmax for CTB-011 | 686 ± 292 | 610 ± 240 |
| Cmax for CTB-012 | 959 ± 449 | 879 ± 400 |
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.
| L/day | Imovax, SYN023 | RabAvert, SYN023 |
|---|---|---|
| clearance rates for CTB011 | 1.18 ± 0.62 | 1.14 ± 0.59 |
| clearance rates for CTB012 | 0.74 ± 0.29 | 0.77 ± 0.46 |
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.
| day | Imovax, SYN023 | RabAvert, SYN023 |
|---|---|---|
| t1/2 for CTB-011 | 19.19 ± 6.64 | 22.12 ± 5.18 |
| t1/2 for CTB-012 | 20.76 ± 8.73 | 22.86 ± 8.7 |
Collected over 112 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Imovax, Human Rabies Immune Globulin | 0/40 (0%) | 0/40 (0%) | 20/40 (50%) |
| RabAvert, Human Rabies Immune Globulin | 0/42 (0%) | 0/42 (0%) | 25/42 (59.5%) |
| Imovax, SYN023 | 0/40 (0%) | 0/40 (0%) | 24/40 (60%) |
| RabAvert, SYN023 | 0/42 (0%) | 1/42 (2.4%) | 31/42 (73.8%) |
| Event | Imovax, Human Rabies Immune Globulin | RabAvert, Human Rabies Immune Globulin | Imovax, SYN023 | RabAvert, SYN023 |
|---|---|---|---|---|
| Troponin I increasedInvestigations | 0/40 | 0/42 | 0/40 | 1/42 |
| Event | Imovax, Human Rabies Immune Globulin | RabAvert, Human Rabies Immune Globulin | Imovax, SYN023 | RabAvert, SYN023 |
|---|---|---|---|---|
| Injection site painGeneral disorders | 7/40 | 6/42 | 11/40 | 20/42 |
| Viral upper respiratory tract infectionInfections and infestations | 1/40 | 2/42 | 3/40 | 6/42 |
| Red blood cells urine positiveInvestigations | 1/40 | 5/42 | 1/40 | 1/42 |
| Injection site haemorrhageGeneral disorders | 0/40 | 1/42 | 1/40 | 4/42 |
| Injection site erythemaGeneral disorders | 3/40 | 0/42 | 1/40 | 2/42 |
| Haemoglobin decreasedInvestigations | 1/40 | 0/42 | 3/40 | 2/42 |
| Influenza like illnessGeneral disorders | 1/40 | 3/42 | 0/40 | 3/42 |
| Vessel puncture site bruiseGeneral disorders | 2/40 | 2/42 | 1/40 | 2/42 |
| Catheter site haemorrhageGeneral disorders | 0/40 | 0/42 | 2/40 | 0/42 |
| Haematocrit decreasedInvestigations | 1/40 | 0/42 | 2/40 | 0/42 |
| Age, Categorical(Participants) | Imovax, SYN023 | Imovax, Human Rabies Immune Globulin | RabAvert, SYN023 | RabAvert, Human Rabies Immune Globulin | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 40 | 40 | 42 | 42 | 164 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Imovax, SYN023 | Imovax, Human Rabies Immune Globulin | RabAvert, SYN023 | RabAvert, Human Rabies Immune Globulin | Total |
|---|---|---|---|---|---|
| Female | 28 | 27 | 28 | 20 | 103 |
| Male | 12 | 13 | 14 | 22 | 61 |
| Ethnicity (NIH/OMB)(Participants) | Imovax, SYN023 | Imovax, Human Rabies Immune Globulin | RabAvert, SYN023 | RabAvert, Human Rabies Immune Globulin | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 37 | 37 | 39 | 40 | 153 |
| Not Hispanic or Latino | 3 | 3 | 3 | 2 | 11 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Imovax, SYN023 | Imovax, Human Rabies Immune Globulin | RabAvert, SYN023 | RabAvert, Human Rabies Immune Globulin | Total |
|---|---|---|---|---|---|
| United States | 40 | 40 | 42 | 42 | 164 |
| BMI(kg/m^2) | Imovax, SYN023 | Imovax, Human Rabies Immune Globulin | RabAvert, SYN023 | RabAvert, Human Rabies Immune Globulin | Total |
|---|---|---|---|---|---|
| Mean | 24.41 ± 2.87 | 25.74 ± 2.96 | 24.92 ± 2.66 | 24.39 ± 3.14 | 24.86 ± 2.93 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: SYN023 · Rabies virus strain PM-1503-3M antigen (propiolactone inactivated) · Rabies virus strain flury LEP antigen (propiolactone inactivated)
Synermore Biologics Co., Ltd.