Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
491 participants
OBSERVATIONAL
2009-01-31
2010-05-31
Brief Summary
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The objective of this study is to obtain efficacy and safety data regarding the rabies boostering program to demonstrate that:
1. Rabies immune plasma production can be substantially increased by giving booster doses to previously immunized donors whose titers are below 10.0 IU/mL.
2. It is safe for normal Source Plasma donors to receive booster doses of rabies vaccine on a regular basis.
This study utilizes two rabies vaccines approved by the FDA, Imovax® (Sanofi-Pasteur) and RabAvert® (Novartis).
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Study Groups
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RabAvert
Rabies Vaccine (RabAvert)
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.
Imovax
Rabies Vaccine (Imovax)
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.
Interventions
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Rabies Vaccine (RabAvert)
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.
Rabies Vaccine (Imovax)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Completed initial series of rabies antibody injections with no serious adverse events for at least 90 days prior to enrollment
* Compliance with program requirements
* Signed informed consent
Exclusion Criteria
* Non-compliance with the program
* Experience a serious adverse reaction
18 Years
ALL
Yes
Sponsors
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CSL Plasma
UNKNOWN
CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Toby L. Simon, MD
Role: PRINCIPAL_INVESTIGATOR
CSL Plasma
Locations
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CSL Donor Plasma Center
Tempe, Arizona, United States
CSL Donor Plasma Center
Rock Island, Illinois, United States
CSL Donor Plasma Center
Oak Park, Michigan, United States
CSL Donor Plasma Center
Saint Paul, Minnesota, United States
CSL Donor Plasma Center
Cleveland, Ohio, United States
CSL Donor Plasma Center
Springfield, Ohio, United States
CSL Donor Plasma Center
Oklahoma City, Oklahoma, United States
CSL Donor Plasma Center
Medord, Oregon, United States
CSL Donor Plasma Center
Knoxville, Tennessee, United States
CSL Donor Plasma Center
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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ZLB 1
Identifier Type: -
Identifier Source: org_study_id
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