Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed
Status:
Completed
Trial end date:
2017-06-06
Target enrollment:
Participant gender:
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.