At a glance
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A Phase I, Open-label, Ascending Dose Study to Determine the Safety and Reactogenicity of a Wild Type Seasonal A/California/ H1N1 2009 Influenza Challenge Virus in Healthy Volunteers, Following a Single Intranasal Administration
In Brief
A Phase 1 clinical trial evaluating Live, wild-type A/California/H1N1 2009 influenza virus for Influenza. Completed, enrolled 35 participants.
Detailed Summary
This is a non-controlled, open-label, single-center, dose-escalation study to determine the safety, infectivity, and immune responses elicited from of the potential influenza virus challenge strain. The study objective is to determine the dose with the optimal safety profile and infectivity rate of the viral challenge strain in healthy volunteers for use in subsequent challenge intervention studies to test potential influenza vaccines and/or therapeutics.
Study Details
Timeline
Interventions
Live, wild type influenza A virus that was inoculated and manufactured in allantoic fluid of SPF embryonated hen eggs