clinical trial · NCT02339155
Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed
Emergent BioSolutions·phase4·completed·n = 573
Infections, BacterialAVARaxibacumabDiphenhydramine
brief 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.
started
Feb 24, 2015
primary completion
Jan 3, 2017
completion
Jun 6, 2017
last updated
Mar 18, 2024
official title
A Randomized, Open-label Study to Evaluate the Immunogenicity of Anthrax Vaccine Adsorbed Alone or Concomitantly With Raxibacumab (GSK3068483)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol