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Anthrax Vaccine Clinical Trial to Assess Dose Reduction and Route Change

NCT00119067 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1564

Last updated 2024-05-29

Study results available
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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

  • Healthy

Interventions

BIOLOGICAL

Anthrax Vaccine Adsorbed

BIOLOGICAL

Saline injection

Sponsors & Collaborators

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • Baylor College of Medicine

    collaborator OTHER

  • University of Alabama at Birmingham

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • Mayo Clinic

    collaborator OTHER

  • Centers for Disease Control and Prevention

    lead FED

Principal Investigators

  • Jennifer Wright, DVM · Centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
61 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00119067 on ClinicalTrials.gov