SERIOUS ADVERSE EVENTS IN CANADIAN CHILDREN RECEIVING PALIVIZUMAB FOR THE PREVENTION OF RESPIRATORY SYNCYTIAL VIRUS INFECTION
Author(s)
Chan P1, Chen J1, Paes B2, Mitchell I3, Li A1, Lanctôt K1
1Sunnybrook Health Sciences Centre, Toronto, ON, Canada, 2McMaster University, Hamilton, ON, Canada, 3University of Calgary, Calgary, AB, Canada
BACKGROUND: A landmark in the prevention of serious respiratory syncytial virus (RSV) infection was established with the release of palivizumab, a recombinant, humanized, genetically-engineered monoclonal antibody. Palivizumab has been deemed safe in clinical trials without major, serious adverse events (SAEs). OBJECTIVES: The primary objective of this study is to evaluate the safety and tolerability of palivizumab for RSV infection prophylaxis in high-risk children. METHODS: High-risk children prophylaxed against RSV infection were recruited into a prospective, observational, Canadian RSV Evaluation Study of Palivizumab (CARESS) registry with active SAE monitoring from 2008 to 2013. SAE reports were systematically collected and assessed for severity and relationship to palivizumab. Data were analyzed by using Chi-square or Fisher Exact Tests to examine group differences in proportions. RESULTS:
Conference/Value in Health Info
2015-05, ISPOR 2015, Philadelphia, PA, USA
Value in Health, Vol. 18, No. 3 (May 2015)
Code
PIN5
Topic
Clinical Outcomes, Epidemiology & Public Health
Topic Subcategory
Relating Intermediate to Long-term Outcomes, Safety & Pharmacoepidemiology
Disease
Infectious Disease (non-vaccine)