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NCT00119067 · ClinicalTrials.gov registry record · Phase 4

Anthrax Vaccine Clinical Trial to Assess Dose Reduction and Route Change

A Phase 4 study of Healthy, sponsored by Centers for Disease Control and Prevention.

Completed
Registry status
Phase 4
Development phase
1,564
Enrollment target
5
Study locations

NCT00119067 is a Phase 4 study of Healthy that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 1,564 participants, above the 646-participant average among 1,090 other Healthy trials with a reported enrollment target (142% higher). The trial reports 5 study locations across 5 states.

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The verdict

NCT00119067, a Phase 4 study of Healthy, has completed, sponsored by Centers for Disease Control and Prevention.

COMPLETED
Registry status
Phase 4
Development phase
1,564 participants
Enrollment target
5
Study locations

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

What the Registry Record Tells You About NCT00119067

The ClinicalTrials.gov registry entry for NCT00119067 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,564 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 646-participant average among 1,090 other Healthy trials with a reported enrollment target (142% higher). The listed sponsor is Centers for Disease Control and Prevention, which has 139 total studies on file at ClinicalTrials.gov.

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.

NCT00119067 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Alabama, Georgia, Maryland.

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.

What interventions are being tested in trial NCT00119067?

The interventions under investigation include: Saline injection (BIOLOGICAL), Anthrax Vaccine Adsorbed (BIOLOGICAL).

Who is sponsoring clinical trial NCT00119067?

This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.

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.

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

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