Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention.

ABSTRACT:

Objectives

To evaluate the safety and tolerability of palivizumab for RSV prophylaxis in high-risk children in everyday practice.

Methods

High-risk children prophylaxed against RSV infection were recruited into a prospective, observational, Canadian RSV Evaluation Study of Palivizumab (CARESS) registry with active, serious adverse event (SAE) monitoring from 2008 to 2013. SAE reports were systematically collected and assessed for severity and relationship to palivizumab. Data were analyzed by Chi-square or Fisher Exact Tests to examine group differences in proportions.

Results

13025 infants received 57392 injections. Hospitalizations for respiratory-related illness (RIH) were reported in 915 patients, and SAEs other than RIH were reported in 52 patients. Of these, 6 (

SUBMITTER: Chen JJ 

PROVIDER: S-EPMC4523213 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature