At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 61 years (up to 62nd birthday)
- ✓Two intact upper arms with sufficient subcutaneous and intramuscular tissue in deltoid regions for vaccine administration
- ✓Willingness and ability to return for all follow-up visits and blood collections for the duration of the study
- ✓Ability to understand and comply with planned study procedures
- ✕Prior history of anthrax or immunization against anthrax
- ✕Known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or latex
- ✕Pregnant, plans to become pregnant during study, or does not agree to adequate birth control from screening to one month after last vaccination
- ✕Used cytotoxic therapy in previous 5 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Anthrax Vaccine Adsorbed: Human Reactogenicity and Immunogenicity Trial to Address Change in Route of Administration and Dose Reduction
In Brief
A Phase 4 clinical trial evaluating Anthrax Vaccine Adsorbed and Saline injection for Healthy. Completed, enrolled 1,564 participants across 5 sites.
Detailed Summary
Anthrax Clinical Trial Objectives: To assess whether: * Anthrax vaccine (AVA or BioThrax, BioPort Corp. Lansing MI) administered by the intramuscular (IM) route elicits antibody responses that are not inferior (i.e., "non-inferior") to that achieved by the currently licensed schedule. * BioThrax administered by the IM route and containing fewer numbers of doses elicits antibody responses that are not inferior (i.e., "non-inferior") to that achieved by the currently licensed schedule. * Differences in reactogenicity exist between the IM and subcutaneous (SQ) administration of BioThrax. Additionally for the final report we will assess whether: * Occurrence of adverse events following AVA administration is influenced by selected risk factors.