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NCT01063140 · ClinicalTrials.gov registry record
Rabies Immune Plasma Booster Study
A clinical trial, sponsored by CSL Behring.
- Completed
- Registry status
- 491
- Enrollment target
NCT01063140 is a clinical trial that has completed, run by CSL Behring. The registered enrollment target is 491 participants.
The verdict
NCT01063140 has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- 491 participants
- Enrollment target
Study Summary
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: 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).
Interventions
- BIOLOGICAL Rabies Vaccine (RabAvert)
- BIOLOGICAL Rabies Vaccine (Imovax)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 491 participants |
| Start Date | 2009-01 |
| Est. Completion | 2010-05 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01063140
The ClinicalTrials.gov registry entry for NCT01063140 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 491 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rabies Vaccine (RabAvert) is the first listed.
NCT01063140 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01063140 about?
NCT01063140 is a clinical study titled "Rabies Immune Plasma Booster Study". 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 th...
What is the current status of trial NCT01063140?
This trial is currently completed. The enrollment target is 491 participants. The study started on 2009-01. Estimated completion is 2010-05.
What interventions are being tested in trial NCT01063140?
The interventions under investigation include: Rabies Vaccine (RabAvert) (BIOLOGICAL), Rabies Vaccine (Imovax) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01063140?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
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