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Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed

NCT02339155 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 573

Last updated 2024-03-18

Study results available
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Summary

This study, as a post-marketing commitment to the Food and Drug Administration, is designed to detect the effect of raxibacumab on anthrax vaccine adsorbed (AVA) immunogenicity in a healthy volunteer population. This is a randomized, open-label, parallel group, two arm study to compare the immunogenicity of AVA at 4 weeks after the first AVA dose, when AVA is administered alone or concomitantly with raxibacumab. The study is planned to enroll approximately 30 to 534 subjects in up to 3 cohorts. The total duration of the study will be approximately 26 weeks. The dates reflect cohort 1.

Conditions

  • Infections, Bacterial

Interventions

BIOLOGICAL

AVA

Sterile, milky-white suspension with dosage level of 0.5 mL for SC administration

BIOLOGICAL

Raxibacumab

Sterile, liquid formulation with unit dose strength of 40 mg/ kg for IV administration

DRUG

Diphenhydramine

Depending upon the labelling of the specific product chosen, 25 - 50 mg will be administered orally or IV

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Emergent BioSolutions

    lead INDUSTRY

Principal Investigators

  • Paul-Andre deLame, MD · Emergent BioSolutions Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-02-24
Primary Completion
2017-01-03
Completion
2017-06-06

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 NCT02339155 on ClinicalTrials.gov