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Completed Phase 4 Interventional Accepts healthy volunteers Results available

Anthrax Vaccine Clinical Trial to Assess Dose Reduction and Route Change

ClinicalTrials.gov ID: NCT00119067

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.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 8:45 AM EDT

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

Interventions

Biological

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
May 2002 (Type not available)
Primary completion
Feb 2010 (Actual)
Completion
Feb 2010 (Actual)
Last update posted
May 29, 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 29, 2024 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00119067 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →