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H5 Vaccine Alone or With Aluminum Hydroxide in Elderly Adults
NCT00294099 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to compare how the body reacts to different strengths of the new A/H5N1 flu vaccine when given with the addition of aluminum hydroxide adjuvant and provide dosing information. How the body's immune system responds to the new H5N1vaccine with aluminum hydroxide approximately 1 month following receipt of 2 doses of vaccine will also be evaluated. The vaccine is given as an injection or shot in the arm. Volunteer participants in this study will be 600 healthy elderly adults, aged 65 years and older. Participants will be randomly assigned to 4 different dosage groups of vaccine, either with or without adjuvant, for a total of 8 different groups. Volunteers will participate in the study for 7 months. Each individual will receive two vaccinations, the second 28 days after the first. In addition to visits for these vaccinations, subjects will return to the clinic for physical evaluations and blood sample collection 6 times during the course of this study.
Conditions Studied
Interventions
- BIOLOGICAL Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)
- BIOLOGICAL Aluminum hydroxide
Study Locations (7)
Iowa
- University of Iowa — Iowa City
Maryland
- University of Maryland Baltimore — Baltimore
Missouri
- Saint Louis University — St Louis
New York
- University of Rochester — Rochester
Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati
Tennessee
- Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center — Nashville
Texas
- Baylor College of Medicine — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2006-03 |
| Est. Completion | 2007-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00294099
The ClinicalTrials.gov registry entry for NCT00294099 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 600 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 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions — of which Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00294099 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Iowa, Maryland, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00294099 about?
NCT00294099 is a clinical study titled "H5 Vaccine Alone or With Aluminum Hydroxide in Elderly Adults". The purpose of this study is to compare how the body reacts to different strengths of the new A/H5N1 flu vaccine when given with the addition of aluminum hydroxide adjuvant and provide dosing information. How the body's immune system responds to the new H5N1vaccine with aluminum hydroxide approximat...
What is the current status of trial NCT00294099?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 600 participants. The study started on 2006-03. Estimated completion is 2007-03.
What conditions does trial NCT00294099 study?
This clinical trial studies the following conditions: Influenza. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00294099?
The interventions under investigation include: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) (BIOLOGICAL), Aluminum hydroxide (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00294099?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00294099 being conducted?
This trial has 7 study locations across Iowa, Maryland, Missouri, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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