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NCT01137669 · ClinicalTrials.gov registry record · Phase 1
ZOSTAVAX® in Renal Transplant Patients
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01137669 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 34 participants.
The verdict
NCT01137669, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety of a licensed zoster vaccine, ZOSTAVAX® (Zoster Vaccine Live) in 40 subjects, age 18 years or older, with chronic kidney disease (CKD) who are scheduled to receive a living donor kidney transplant. ZOSTAVAX® is not licensed for use in immunosuppressed persons and in the United States for individuals less than 50 years of age. Subjects will receive either ZOSTAVAX® vaccine or placebo (inactive substance) no less than 4 weeks prior to their kidney transplant. Study procedures include: physical exam, blood samples and documentation of daily temperatures and/or side effects in a diary following vaccination. Participants may be involved in study related procedures for up to 18 months.
Interventions
- OTHER Placebo
- BIOLOGICAL Live attenuated herpes zoster vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2010-09 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01137669
The ClinicalTrials.gov registry entry for NCT01137669 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01137669 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01137669 about?
NCT01137669 is a clinical study titled "ZOSTAVAX® in Renal Transplant Patients". The purpose of this study is to test the safety of a licensed zoster vaccine, ZOSTAVAX® (Zoster Vaccine Live) in 40 subjects, age 18 years or older, with chronic kidney disease (CKD) who are scheduled to receive a living donor kidney transplant. ZOSTAVAX® is not licensed for use in immunosuppressed ...
What is the current status of trial NCT01137669?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2010-09. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01137669?
The interventions under investigation include: Placebo (OTHER), Live attenuated herpes zoster vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01137669?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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