Anthrax Vaccine Clinical Trial to Assess Dose Reduction and Route Change
Public ClinicalTrials.gov record NCT00119067. 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
Anthrax Vaccine Adsorbed: Human Reactogenicity and Immunogenicity Trial to Address Change in Route of Administration and Dose Reduction
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Anthrax Clinical Trial Objectives: To assess whether: * Anthrax vaccine (AVA or BioThrax, BioPort Corp. Lansing MI) administered by the intramuscular (IM) route elicits antibody responses that are not inferior (i.e., "non-inferior") to that achieved by the currently licensed schedule. * BioThrax administered by the IM route and containing fewer numbers of doses elicits antibody responses that are not inferior (i.e., "non-inferior") to that achieved by the currently licensed schedule. * Differences in reactogenicity exist between the IM and subcutaneous (SQ) administration of BioThrax. Additionally for the final report we will assess whether: * Occurrence of adverse events following AVA administration is influenced by selected risk factors.
Study identification
- NCT ID
- NCT00119067
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 1,564 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 61 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
- Apr 30, 2002
- Primary completion
- Jan 31, 2010
- Completion
- Jan 31, 2010
- Last update posted
- May 28, 2024
2002 – 2010
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama, Birmingham (UAB) | Birmingham | Alabama | 35294-2050 | — |
| Emory | Atlanta | Georgia | 30322 | — |
| Walter Reed Army Institute for Research (WRAIR) | Silver Spring | Maryland | 20910-7500 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Baylor | 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 NCT00119067, 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 May 28, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00119067 live on ClinicalTrials.gov.