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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: Clinical Trial Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.
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 |
Why NCT00023504 stopped before completion
NCT00023504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 4 interventions - of which Prevnar is the first listed.
NCT00023504 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00023504's enrollment target sits among peer trials
21 1742nd of 2000 higher than 248 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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