Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection

Exclusion Criteria

• •1. Subject was known to have significant comorbidities including:
• •* Genetic disorders (e.g., trisomy 21, cystic fibrosis),
• •* Hemodynamically significant congenital heart disease (e.g., needing corrective therapy or inotropic support),
• •* Bronchopulmonary dysplasia,
• •* Any hereditary or acquired metabolic (bone) diseases,
• •* Hematologic or other malignancy.
• •2. Subject was known to be human immunodeficiency virus (HIV)-positive. If the subject was \< 6 months of age, a known HIV-positivity of the mother was also exclusionary.
• •3. Subject was known to be immunocompromised.
• •4. Subject had or was suspected to have an active, clinically relevant concurrent infection (e.g., bacterial pneumonia, urinary tract infection). Concurrent acute otitis media was not exclusionary.
• •5. Subject had significant oral and/or maxillofacial malformations that would prevent proper positioning of the face mask.
• •6. Subject received invasive mechanical ventilation or non-invasive respiratory support (i.e., continuous or bilevel positive airway pressure) in the 4 weeks prior to screening.
• •7. During the admission, the subject was initially hospitalized in an intensive care unit (ICU) setting and/or had received invasive mechanical ventilation or non-invasive respiratory support (i.e., continuous or bilevel positive airway pressure).
• •8. Subject was critically ill and/or was expected to require invasive mechanical ventilation, non invasive respiratory support (i.e., continuous or bilevel positive airway pressure), or High Flow oxygen therapy (HFOT) at levels not enabling nebulization therapy according to the Investigator's judgment. High Flow oxygen, with a maximum flow of 2 L/kg/min, was permitted under the following conditions:
• •* used as Standard of Care outside ICU setting
• •* could be removed for study drug administration (Note: oxygen flow at 2 L/min could be provided)