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NCT03877926 · ClinicalTrials.gov registry record · Phase 3

VELOCITY: An Anthrax Vaccine Clinical Study

A Phase 3 study of Anthrax, sponsored by Emergent BioSolutions.

Completed
Registry status
Phase 3
Development phase
3,862
Enrollment target
20
Study locations

NCT03877926: Completed Phase 3 study of Anthrax, sponsored by Emergent BioSolutions.

NCT03877926 is a Phase 3 study of Anthrax that has completed, run by Emergent BioSolutions. The registered enrollment target is 3,862 participants, above the 135-participant average among 6 other Anthrax trials with a reported enrollment target (2761% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03877926, a Phase 3 study of Anthrax, has completed, sponsored by Emergent BioSolutions.

COMPLETED
Registry status
Phase 3
Development phase
3,862 participants
Enrollment target
20
Study locations

Study Summary

This study is designed to evaluate the lot consistency (using three consecutively manufactured lots), safety, and ability of the AV7909 anthrax vaccine to generate an immune response in healthy adults and compare the response to that induced by the currently licensed vaccine, BioThrax®, (Anthrax Vaccine Adsorbed; AVA) for post-exposure of anthrax disease.

Primary Outcome

GMT of TNA NF50 at Day 64 in AV7909 study groups (Lots 1, 2 and 3) and BioThrax group. The outcome measure in AV7909 study groups was assessed for AV7909 lot-to-lot consistency, which was based on GMT TNA NF50 response at Day 64, wherein the 95% confidence interval (CI) for ratios of geometric mean titer (GMT) of TNA NF50 at Day 64 (seven weeks after second AV7909 vaccination) for each of the three AV7909 lot-to-lot comparisons had to be within equivalence margin of 0.5 and 2.0.

Conditions Studied

Interventions

  • BIOLOGICAL AV7909
  • BIOLOGICAL BioThrax

Study Locations (20)

Kansas

  • Heartland Research Associates, LLC - Augusta
  • Hutchinson Clinic - Hutchinson
  • Johnson County Clin-Trials, LLC - Lenexa
  • Heartland Research Associates, LLC - Wichita

Alabama

  • Achieve Clinical Research, LLC - Birmingham
  • Optimal Research, LLC - Huntsville
  • Coastal Clinical Research, an AMR company - Mobile

Florida

  • Research Centers of America - Hollywood
  • Optimal Research, LLC - Melbourne
  • New Horizon Research Center, Inc - Miami

Arizona

  • Central Phoenix Medical Clinic, LLC - Phoenix
  • Clinical Research Consortium, an AMR company - Tempe

California

  • California Research Foundation - San Diego
  • Optimal Research, LLC - San Diego

Illinois

  • Christie Clinic, LLC - Champaign
  • Optimal Research, LLC - Peoria

Georgia

  • Meridian Clinical Research, LLC - Savannah

Idaho

  • Advanced Clinical Research - Boise

Trial Details

FieldValue
Enrollment Target 3,862 participants
Start Date 2019-03-11
Est. Completion 2020-08-06
Phase Phase 3
Emergent BioSolutions

34 total trials

What the finished NCT03877926 record still lists

NCT03877926 is an interventional study that assigns participants to a tested intervention. Its 3,862 participants enrollment target places it among the larger protocols in the corpus, above the 135-participant average among 6 other Anthrax trials with a reported enrollment target (2761% higher).

The record links to 1 condition, with Anthrax appearing as the primary indexed condition, and to 2 interventions - of which AV7909 is the first listed.

NCT03877926 names 20 study sites across 10 states, led by Kansas, Alabama, Florida.

Frequently Asked Questions

What is clinical trial NCT03877926 about?

NCT03877926 is a clinical study titled "VELOCITY: An Anthrax Vaccine Clinical Study". This study is designed to evaluate the lot consistency (using three consecutively manufactured lots), safety, and ability of the AV7909 anthrax vaccine to generate an immune response in healthy adults and compare the response to that induced by the currently licensed vaccine, BioThrax®, (Anthrax Vac...

What is the current status of trial NCT03877926?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,862 participants. The study started on 2019-03-11. Estimated completion is 2020-08-06.

What conditions does trial NCT03877926 study?

This clinical trial studies the following conditions: Anthrax.

What interventions are being tested in trial NCT03877926?

The interventions under investigation include: AV7909 (BIOLOGICAL), BioThrax (BIOLOGICAL).

Who is sponsoring clinical trial NCT03877926?

This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03877926 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Anthrax

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.

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Source: ClinicalTrials.gov NCT03877926, the US trial registry maintained by the National Library of Medicine. NCT03877926 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.