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NCT00133510 · ClinicalTrials.gov registry record · Phase 4
Influenza Vaccine in Pediatric Transplant Subjects
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT00133510 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 60 participants.
The verdict
NCT00133510, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate how well children responds to the recommended trivalent subviron influenza vaccine (flu shot). Children who have had a liver transplant and receive their post-transplant care at Mount Sinai and their siblings are being invited to participate in this study. Study procedures will include a review of medical records, physical examination, and up to 2 flu shots. All participants will receive the flu vaccine. Four weeks after the first flu shot, participants will return to the clinic for a physical exam, blood sample collection, and a second flu shot as recommended. Following each vaccination, parents will be asked to record their children's temperatures and any experienced side effects in a diary card for two weeks. Participants will be involved in study related procedures for up to 8 months.
Interventions
- BIOLOGICAL Trivalent Subviron Influenza vaccine (Fluzone)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2004-11 |
| Est. Completion | 2006-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00133510
The ClinicalTrials.gov registry entry for NCT00133510 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 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 1 intervention - of which Trivalent Subviron Influenza vaccine (Fluzone) is the first listed.
NCT00133510 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00133510 about?
NCT00133510 is a clinical study titled "Influenza Vaccine in Pediatric Transplant Subjects". The purpose of this study is to evaluate how well children responds to the recommended trivalent subviron influenza vaccine (flu shot). Children who have had a liver transplant and receive their post-transplant care at Mount Sinai and their siblings are being invited to participate in this study. St...
What is the current status of trial NCT00133510?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2004-11. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00133510?
The interventions under investigation include: Trivalent Subviron Influenza vaccine (Fluzone) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00133510?
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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