Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
5730
Trial Sponsor
Trial Collaborator
Clinical Trial Start Date
February 24, 2015
0Primary Completion Date
January 3, 2017
0Study Completion Date
June 6, 2017
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Biological0
Drug0
Intervention Name
Raxibacumab0
Diphenhydramine0
AVA0
Interventional Trial Phase
Phase 40
Official Name
A Randomized, Open-label Study to Evaluate the Immunogenicity of Anthrax Vaccine Adsorbed Alone or Concomitantly With Raxibacumab (GSK3068483)0
Last Updated
July 15, 2021
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
None (Open Label)0
Study 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.
Timeline
No Timeline data yet.
Further Resources
No Further Resources data yet.
