Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study of Healthy, sponsored by Centers for Disease Control and Prevention.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
warmth, tenderness, itching, pain, arm motion limitation, erythema, induration, nodule, and bruise. The number of injections analyzable varies for each event based on the presence or absence of reported data.
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
| Field | Value |
|---|---|
| Enrollment Target | 1,564 participants |
| Start Date | 2002-05 |
| Est. Completion | 2010-02 |
| Phase | Phase 4 |
What the finished NCT00119067 record still lists
NCT00119067 is an interventional study that assigns participants to a tested intervention. Its 1,564 participants enrollment target places it among the larger protocols in the corpus, above the 646-participant average among 1,090 other Healthy trials with a reported enrollment target (142% higher).
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 lists 5 locations in 5 states (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.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00119067's enrollment target sits among peer trials
1,564 23rd of 1090 higher than 1,068 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
The Effects of Acute Melatonin Supplementation on Cardiovascular Responses to Sympathetic Activation
RECRUITING · Phase 4
-
Effects of GH and Lirglutide on AgRP
RECRUITING · Phase 4
-
Effects of Caffeine on Reinforcement Learning in Healthy Adults Using PET/MRI
RECRUITING · Phase 4
-
Endothelial Derived Hyperpolarization Factor and Vascular Control
RECRUITING · Phase 4
-
Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion
ACTIVE NOT RECRUITING · Phase 4
-
Pharmacokinetics of Transdermal Metronidazole
ACTIVE NOT RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06034080 · 1,566 participants · NA
Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
- NCT06881069 · 1,560 participants · NA
Reach Through Equitable Implementation in Utah
- NCT06445946 · 1,572 participants · Phase 4
DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
- NCT02650622 · 1,550 participants
Genetic and Metabolic Disease in Children
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia