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BARDA Securing Anthrax Immunity For the Elderly

NCT03518125 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2020-07-21

Study results available
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Summary

This study is designed to assess the safety and ability of BioThrax and AV7909 anthrax vaccines to generate an immune response in adults ≥ 66 years of age in stable health in comparison to adults 18-50 years of age in stable health.

Conditions

  • Anthrax

Interventions

BIOLOGICAL

BioThrax

Other Names: Anthrax Vaccine Adsorbed (AVA)

BIOLOGICAL

AV7909

Anthrax Vaccine Absorbed plus CPG 7909 Adjuvant

DRUG

Sodium chloride injection USP, 0.9% (placebo)

Other Names: Saline Solution

Sponsors & Collaborators

Principal Investigators

  • Carlos Fierro, MD · Johnson County Clin-Trials

  • Derek Muse, MD · JBR Clinical Research

  • Stephan Sharp, MD · Clinical Research Associates, Inc.

  • Cynthia Strout, MD · Coastal Carolina Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2019-01-14
Completion
2019-12-09
FDA Drug
Yes

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 NCT03518125 on ClinicalTrials.gov