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NCT00023504 · ClinicalTrials.gov registry record · Phase 4
Antibody Production in Immune Disorders
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 4
- Development phase
- 21
- Enrollment target
NCT00023504 is a Phase 4 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 21 participants.
The verdict
NCT00023504, a Phase 4 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 21 participants
- Enrollment target
Study Summary
This study will evaluate immune function in people with a known or suspected immune disorder. It will determine participants immune response to vaccines by measuring blood antibody levels after vaccination. Patients enrolled in a NIH protocol involving immune reconstitution (bone marrow transplantation or gene therapy) for a known or suspected primary immune disorder may be eligible for this study. Participants may be asked to have more than one vaccine, based on their age, use of IVIG, past immunization history and underlying immune problem. The possible vaccinations include: Rabies vaccine Diphtheria and tetanus booster 23 valent pneumococcal polysaccharide vaccine Pneumococcal 7-valent conjugate vaccine The diphtheria, tetanus, pneumococcus and rabies vaccines are approved by the Food and Drug Administration (FDA) and used routinely to protect against disease. Study participants will have a blood sample drawn before vaccination. The number of additional samples collected will vary according to the vaccines administered; 1 for rabies; 1 for tetanus; and 1 to 2 for the pneumococcal vaccines. Each sample will be up to 5 teaspoonfuls. Participation in the study may last up to a year, depending on the blood sampling scheduling
Interventions
- BIOLOGICAL Prevnar
- BIOLOGICAL Pneumovax
- BIOLOGICAL Rabavert
- BIOLOGICAL Tetanus diphtheria toxoid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2002-06-13 |
| Est. Completion | 2021-10-14 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00023504
The ClinicalTrials.gov registry entry for NCT00023504 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 21 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 4 interventions - of which Prevnar is the first listed.
NCT00023504 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00023504 about?
NCT00023504 is a clinical study titled "Antibody Production in Immune Disorders". This study will evaluate immune function in people with a known or suspected immune disorder. It will determine participants immune response to vaccines by measuring blood antibody levels after vaccination. Patients enrolled in a NIH protocol involving immune reconstitution (bone marrow transplanta...
What is the current status of trial NCT00023504?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2002-06-13. Estimated completion is 2021-10-14.
What interventions are being tested in trial NCT00023504?
The interventions under investigation include: Prevnar (BIOLOGICAL), Pneumovax (BIOLOGICAL), Rabavert (BIOLOGICAL), Tetanus diphtheria toxoid (BIOLOGICAL).
Who is sponsoring clinical trial NCT00023504?
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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