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NCT00294099 · ClinicalTrials.gov registry record · Phase 1
H5 Vaccine Alone or With Aluminum Hydroxide in Elderly Adults
A Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 600
- Enrollment target
- 7
- Study locations
NCT00294099: Completed Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00294099 is a Phase 1 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 600 participants, below the 36,800-participant average among 156 other Influenza trials with a reported enrollment target (98% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00294099, a Phase 1 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 600 participants
- Enrollment target
- 7
- Study locations
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 |
What the finished NCT00294099 record still lists
NCT00294099 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 36,800-participant average among 156 other Influenza trials with a reported enrollment target (98% lower).
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.
NCT00294099 lists 7 locations in 7 states (Iowa, Maryland, Missouri).
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.
What interventions are being tested in trial NCT00294099?
The interventions under investigation include: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) (BIOLOGICAL), Aluminum hydroxide (BIOLOGICAL).
Who is sponsoring clinical trial NCT00294099?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00294099's enrollment target sits among peer trials
600 44th of 156 higher than 112 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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.
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