Safety and tolerance of palivizumab administration in a large Northern Hemisphere trial. Northern Hemisphere Expanded Access Study Group

Pediatr Infect Dis J. 2001 Jun;20(6):628-30. doi: 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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Clinical Trial, Phase IV
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Monoclonal / administration & dosage*
  • Antibodies, Monoclonal, Humanized
  • Antiviral Agents / administration & dosage*
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Infant, Premature, Diseases / prevention & control*
  • Injections, Intramuscular
  • Male
  • Palivizumab
  • Respiratory Syncytial Virus Infections / prevention & control*
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antiviral Agents
  • Palivizumab