822
Participants
Start Date
January 3, 2017
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
Broncho-Vaxom (BV)
Active Ingredient: Lyophilised bacterial extract; Chemical Name: OM-85 BV; Strength: 3.5 mg; Excipients: bacterial extract, propyl gallate, sodium glutamate, mannitol, pregelatinised starch, magnesium stearate; Appearance: Blue and white capsule; Dosage Form: 3.5 mg capsule; Manufacturer: OM Pharma, Switzerland (OM stands for Omnia Medicamenta) Storage: Store in the original package
Placebo
A placebo capsule will be used that will be indistinguishable from the active study drug.
Columbia University, New York
Children's National Health System, Washington D.C.
University of North Carolina, Chapel Hill
Emory University, Atlanta
Cincinnati Children's Hospital & Medical Center, Cincinnati
Washington University, St Louis
Phoenix Children's Hospital, Phoenix
University of Arizona, Tucson
University of California San Francisco, Benioff Children's Hospital, Oakland
Boston Children's Hospital, Harvard University, Boston
University of Wisconsin, Madison
University of Arizona
OTHER