NCT02339155

Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed

A Randomized, Open-label Study to Evaluate the Immunogenicity of Anthrax Vaccine Adsorbed Alone or Concomitantly With Raxibacumab (GSK3068483)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 573 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2015-02-24
• Primary completion: 2017-01-03
• Completion: 2017-06-06
• First posted: 2015-01-15
• Last updated: 2024-03-18
• Results posted: 2018-01-09

Locations

3 sites across 1 country: United States