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NCT00230750 · ClinicalTrials.gov registry record · Phase 1
Inactivated Influenza A/H5N1 Vaccine in the Elderly
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 261
- Enrollment target
NCT00230750 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 261 participants.
The verdict
NCT00230750, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 261 participants
- Enrollment target
Study Summary
The purpose of this research study is to compare how the body reacts to different strengths of a new H5N1 flu vaccine. Researchers will also look at how antibodies are made after subjects receive the H5N1 flu vaccine. Participants will include at least 240 healthy males and females, aged 65 and older. The vaccine is given as an injection or shot in the arm. Subjects will receive 3 doses of vaccine at Day 0, Month 1 and Month 6. There are 2 different doses of the new H5N1 vaccine that will be given in this study. There is also a chance that a subject may receive a placebo (dummy) injection of saltwater instead of the flu vaccine. Study procedures will include physical exams and blood sample collections. Additionally, participants will complete a memory aid card to document daily temperatures and any symptoms experienced for a week after receiving vaccine. The length of participation in this study will be approximately 14 months.
Interventions
- DRUG Placebo
- BIOLOGICAL Influenza A/H5N1 Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2005-10 |
| Est. Completion | 2007-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00230750
The ClinicalTrials.gov registry entry for NCT00230750 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 261 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.
NCT00230750 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00230750 about?
NCT00230750 is a clinical study titled "Inactivated Influenza A/H5N1 Vaccine in the Elderly". The purpose of this research study is to compare how the body reacts to different strengths of a new H5N1 flu vaccine. Researchers will also look at how antibodies are made after subjects receive the H5N1 flu vaccine. Participants will include at least 240 healthy males and females, aged 65 and olde...
What is the current status of trial NCT00230750?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 261 participants. The study started on 2005-10. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00230750?
The interventions under investigation include: Placebo (DRUG), Influenza A/H5N1 Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00230750?
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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