Dose-Escalating Trial Using Vero Cell-culture Derived H5N1 +/- Aluminum in Adults
Public ClinicalTrials.gov record NCT00382980. 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, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Clinical Trial of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Immunization With Inactivated, Vero Cell-Culture Derived Influenza A/H5N1 Vaccine Given Alone or With Aluminum Hydroxide to Healthy Young Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this research study is to compare how the body reacts to different strengths of an experimental cell culture-grown whole virus A/H5N1 flu vaccine when given with or without the addition of aluminum hydroxide adjuvant. Researchers will also look at how much antibody is made to the influenza virus hemagglutinin (HA) after subjects receive the H5N1 vaccine. Three hundred healthy adults aged 18-40 years will participate for approximately 9 months, which includes screening. Participants will receive 2 doses of vaccine or placebo injected 28 days apart. Participants will have blood samples taken up to 7 times and have 8 scheduled study visits.
Study identification
- NCT ID
- NCT00382980
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 308 participants
Conditions and interventions
Conditions
Interventions
- Aluminum hydroxide Biological
- Inactivated Vero cell based whole virus influenza A/H5N1 Biological
- Placebo Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 40 Years
- 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
- Sep 30, 2006
- Primary completion
- Aug 31, 2007
- Completion
- Aug 31, 2007
- Last update posted
- Aug 26, 2010
2006 – 2007
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | — |
| UCLA Center For Vaccine Research | Torrance | California | 90502 | — |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | — |
| Vanderbilt University | Nashville | Tennessee | 37232 | — |
| 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 NCT00382980, 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 Aug 26, 2010 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00382980 live on ClinicalTrials.gov.