At a glance
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A Randomized, Open-label Study to Evaluate the Immunogenicity of Anthrax Vaccine Adsorbed Alone or Concomitantly With Raxibacumab (GSK3068483)
In Brief
A Phase 4 clinical trial evaluating AVA, Raxibacumab, and 1 other intervention for Infections, Bacterial. Completed, enrolled 573 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
Sterile, milky-white suspension with dosage level of 0.5 mL for SC administration
Sterile, liquid formulation with unit dose strength of 40 mg/ kg for IV administration
Depending upon the labelling of the specific product chosen, 25 - 50 mg will be administered orally or IV