SAFETY AND TOLERANCE OF PALIVIZUMAB ADMINISTRATION IN A LARGE NORTHERN HEMISPHERE TRIAL
- 1 June 2001
- journal article
- clinical trial
- Published by Wolters Kluwer Health in The Pediatric Infectious Disease Journal
- Vol. 20 (6) , 628-630
- https://doi.org/10.1097/00006454-200106000-00018
Abstract
An Expanded Access Study was conducted to collect additional safety data on palivizumab. Preterm infants with or without bronchopulmonary dysplasia received palivizumab every 30 days during the respiratory syncytial virus season. Adverse events were low (6.9%) in the 565 subjects. Serious adverse events included hospitalization and 1 case of respiratory syncytial virus bronchiolitis not requiring hospitalization. This study reaffirms the safety and tolerability of palivizumab.Keywords
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