Palivizumab prophylaxis for respiratory syncytial virus in Canada: utilization and outcomes

Pediatr Infect Dis J. 2002 Jun;21(6):512-8. doi: 10.1097/00006454-200206000-00007.


Objective: To provide information on the use and outcomes of palivizumab prophylaxis in children at high risk of serious respiratory syncytial virus (RSV) infection.

Design: Observational, prospective, longitudinal, multicenter study.

Setting: Eighteen hospitals and pediatric clinics located in six provinces across Canada.

Patients: Infants enrolled in the palivizumab Special Access Programme of Canada's Therapeutic Products Programme throughout the 1999 to 2000 RSV season. Most were premature infants born at < or = 32 weeks of gestation and/or had bronchopulmonary dysplasia.

Methods and main outcome measures: Neonatal and demographic data were recorded for each subject. The parent/caregiver was contacted on a monthly basis until the end of the RSV season to obtain information on palivizumab utilization and compliance as well as incidence and severity of respiratory infections.

Results: There were 444 evaluable subjects who each received 1 to 7 injections of palivizumab for a total of 1702 doses from September 1999 to April 2000. Most subjects received 5 injections with high compliance. Prophylaxis was discontinued in 2% of children. There were 116 clinical events or hospitalizations involving respiratory tract infections reported in 91 children. Eighty-six of these were managed in an outpatient setting, and 30 required hospitalization. The estimated incidence of hospitalization for RSV-positive lower respiratory tract infections (LRTIs) was 2.4%. Hospitalization for RSV LRTI occurred more often in children with bronchopulmonary dysplasia (6.0%) than in those with prematurity only (1.6%).

Conclusions: This study demonstrates that prophylaxis with palivizumab during the RSV season was associated with a low rate of hospitalization for RSV-positive LRTIs. Palivizumab was well-tolerated, and compliance was high. The findings confirm the results of the major randomized clinical trial of palivizumab and demonstrate the safety and effectiveness of RSV prophylaxis.

Publication types

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

MeSH terms

  • Antibodies, Monoclonal / pharmacology
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized
  • Antiviral Agents / pharmacology
  • Antiviral Agents / therapeutic use*
  • Bronchopulmonary Dysplasia / pathology
  • Canada
  • Demography
  • Female
  • Guideline Adherence / standards
  • Hospitalization
  • Humans
  • Infant, Newborn
  • Infant, Premature / immunology
  • Longitudinal Studies
  • Male
  • Palivizumab
  • Respiratory Syncytial Virus Infections / drug therapy
  • Respiratory Syncytial Virus Infections / prevention & control*
  • Respiratory Syncytial Viruses / drug effects
  • Risk Factors
  • Treatment Outcome


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