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COMPLETED Phase 4

Anthrax Vaccine Clinical Trial to Assess Dose Reduction and Route Change

NCT00119067 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • BIOLOGICAL Saline injection
  • BIOLOGICAL Anthrax Vaccine Adsorbed

Study Locations (5)

Alabama

  • University of Alabama, Birmingham (UAB) — Birmingham

Georgia

  • Emory — Atlanta

Maryland

  • Walter Reed Army Institute for Research (WRAIR) — Silver Spring

Minnesota

  • Mayo Clinic — Rochester

Texas

  • Baylor — Houston

Trial Details

FieldValue
Enrollment Target 1,564 participants
Start Date 2002-05
Est. Completion 2010-02
Phase Phase 4

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00119067

The ClinicalTrials.gov registry entry for NCT00119067 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,564 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Centers for Disease Control and Prevention, which has 42 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions — of which Saline injection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00119067 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Alabama, Georgia, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00119067 about?

NCT00119067 is a clinical study titled "Anthrax Vaccine Clinical Trial to Assess Dose Reduction and Route Change". 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 a...

What is the current status of trial NCT00119067?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,564 participants. The study started on 2002-05. Estimated completion is 2010-02.

What conditions does trial NCT00119067 study?

This clinical trial studies the following conditions: Healthy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00119067?

The interventions under investigation include: Saline injection (BIOLOGICAL), Anthrax Vaccine Adsorbed (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00119067?

This trial is sponsored by Centers for Disease Control and Prevention, which has 42 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00119067 being conducted?

This trial has 5 study locations across Alabama, Georgia, Maryland, Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial