H5 Vaccine Alone or With Aluminum Hydroxide in Elderly Adults
Public ClinicalTrials.gov record NCT00294099. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I-II, Randomized, Controlled, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine Given Alone or With Aluminum Hydroxide to Healthy Elderly Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00294099
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 600 participants
Conditions and interventions
Conditions
Interventions
- Aluminum hydroxide Biological
- Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) Biological
Biological
Eligibility (public fields only)
- Age range
- 65 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2006
- Primary completion
- Feb 28, 2007
- Completion
- Feb 28, 2007
- Last update posted
- Jun 2, 2013
2006 – 2007
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Maryland Baltimore | Baltimore | Maryland | 21201 | — |
| Saint Louis University | St Louis | Missouri | 63104 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | — |
| Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center | Nashville | Tennessee | 37232-2573 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00294099, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 2, 2013 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00294099 live on ClinicalTrials.gov.