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| Name | Class |
|---|---|
| CSL Plasma | UNKNOWN |
Rabies immune globulin is a product that is lifesaving to unvaccinated individuals exposed to the rabies virus. Rabies immune globulin is made from plasma from immune donors. Currently the only practical method to obtain this plasma is to immunize normal volunteer Source Plasma donors and collect their plasma while titers are adequate. The use of rabies vaccine for immunization of normal Source Plasma donors is currently limited to a level that, while protective for the individual, is unsuitable for production of rabies immune globulin.
The objective of this study is to obtain efficacy and safety data regarding the rabies boostering program to demonstrate that:
This study utilizes two rabies vaccines approved by the FDA, Imovax® (Sanofi-Pasteur) and RabAvert® (Novartis).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RabAvert |
| ||
| Imovax |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rabies Vaccine (RabAvert) | Biological | The initial booster immunization is given on Day 1; subsequent booster immunizations will be administered if the donor's titers fall below 10 IU/mL. A maximum of 4 booster immunizations may be administered over the 2 year study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer (GMT) for rabies plasma donations received after booster injections | 30-day intervals for the duration of the study (up to 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Reaction Rate | 30-35 days after each injection |
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Inclusion Criteria:
Exclusion Criteria:
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Source Plasma Donors. Donors must meet FDA and CSL Plasma requirements to be Source Plasma Donors. Donors had previously participated in CSL's rabies vaccine immunization program.
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| Name | Affiliation | Role |
|---|---|---|
| Toby L. Simon, MD | CSL Plasma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CSL Donor Plasma Center | Tempe | Arizona | 85282 | United States | ||
| CSL Donor Plasma Center |
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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 (Imovax) | Biological | The initial booster immunization is given on Day 1; subsequent booster immunizations will be administered if the donor's titers fall below 10 IU/mL. A maximum of 4 booster immunizations may be administered over the 2 year study period. |
|
| Rock Island |
| Illinois |
| 61201 |
| United States |
| CSL Donor Plasma Center | Oak Park | Michigan | 48237 | United States |
| CSL Donor Plasma Center | Saint Paul | Minnesota | 55104 | United States |
| CSL Donor Plasma Center | Cleveland | Ohio | 44109 | United States |
| CSL Donor Plasma Center | Springfield | Ohio | 45503 | United States |
| CSL Donor Plasma Center | Oklahoma City | Oklahoma | 73103 | United States |
| CSL Donor Plasma Center | Medord | Oregon | 97501 | United States |
| CSL Donor Plasma Center | Knoxville | Tennessee | 37916 | United States |
| CSL Donor Plasma Center | Salt Lake City | Utah | 84115 | United States |
| D007239 | Infections |