Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02339155
Study type Interventional
Source Emergent BioSolutions
Contact
Status Completed
Phase Phase 4
Start date February 24, 2015
Completion date June 6, 2017

See also
  Status Clinical Trial Phase
Completed NCT04079790 - Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects Phase 1
Completed NCT01934205 - To Evaluate Plasma and Pulmonary Pharmacokinetics of GSK2140944 Phase 1
Not yet recruiting NCT02177721 - Clinical Benefit, Safety and PK of Raxibacumab in Subjects Exposed to Bacillus Anthracis Phase 4
Suspended NCT01132417 - In Vitro Activity of Tigecycline Among Key Bacterial Pathogens Exhibiting Multidrug Resistance N/A
Completed NCT00539994 - Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus Phase 2
Completed NCT01610388 - A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects Phase 1
Completed NCT01262885 - A Randomized, Single Blind, Placebo Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses and Repeat Escalating Oral Doses of GSK2251052 in Healthy Adult Subjects Phase 1
Completed NCT00427141 - A Three-Part Study Of GSK580416 In Healthy Subjects Phase 1
Completed NCT04620486 - Effect of BPA on Anchor Antibiotic Continuity in the ED: Randomized Controlled Trial N/A
Recruiting NCT06451172 - Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis Early Phase 1
Not yet recruiting NCT06440304 - Therapeutic Options for CRAB Phase 4
Completed NCT02292498 - Thermal Imaging to Diagnose and Monitor Suspected Bacterial Infections N/A
Completed NCT01587768 - WEUKBRE5555: IMI PROTECT(Work Package 2): Liver Injury & Antibiotics N/A
Withdrawn NCT01039610 - A Single Center Four Part Study in Healthy Adult Subjects to Evaluate: the Safety, Tolerability and Pharmacokinetics of a Single Oral Dose and Repeat Escalating Oral Doses of GSK945237; the Effect of Linezolid on Hematology Safety Parameters; and the Effects of GSK945237 and Moxifloxacin on QTc. Phase 1
Completed NCT00259909 - Observational Study Of An Electronic Questionnaire In Patients With Chronic Obstructive Pulmonary Disease (COPD) N/A
Completed NCT00828867 - Single Dose Escalation First Time in Human PK Study Phase 1
Completed NCT01431989 - Amoxicillin Bioequivalence Study Brazil - Fast Phase 1
Completed NCT02778672 - Thermal Imaging of the Lung on a Smartphone to Differentiate Bacterial From Non Bacterial Causes of Pneumonia N/A
Completed NCT00896558 - A Repeat Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Subjects Phase 1
Completed NCT02045797 - Dose-Ranging Study of GSK2140944 in the Treatment of Subjects With Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections Phase 2