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Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults

NCT01263691 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-03-18

Study results available
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Summary

The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant medications, and local and systemic signs and symptoms of reactogenicity.

Conditions

  • Bacillus Anthracis (Anthrax) Infection

Interventions

BIOLOGICAL

BioThrax

BioThrax

BIOLOGICAL

AV7909 Formulation 1

AV7909 Formulation 1

BIOLOGICAL

AV7909 Formulation 2

AV7909 Formulation 2

BIOLOGICAL

AV7909 Formulation 3

AV7909 Formulation 3

BIOLOGICAL

AV7909 Formulation 4

AV7909 Formulation 4

DRUG

Control

Saline control

Sponsors & Collaborators

Principal Investigators

  • Edward Bernton, MD · Emergent Biosolutions, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-05-31
Completion
2012-06-30

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 NCT01263691 on ClinicalTrials.gov