Clinical Endpoints for Respiratory Syncytial Virus Prophylaxis Trials in Infants and Children in High-income and Middle-income Countries

2015 ◽  
Vol 34 (10) ◽  
pp. 1086-1092 ◽  
Author(s):  
Eric A.F. Simões ◽  
Xavier Carbonell-Estrany ◽  
Theresa Guilbert ◽  
Jonathan M. Mansbach ◽  
Pedro A. Piedra ◽  
...  
1997 ◽  
Vol 31 (1) ◽  
pp. 83-88 ◽  
Author(s):  
Todd L Wandstrat

OBJECTIVE: To review the clinical data detailing the use of respiratory syncytial virus immune globulin intravenous (RSV—IGIV) in infants and children. DATA SOURCES: A MEDLINE search (1990–1996) was used to identify all publications that dealt with RSV—IGIV clinical trials, pharmacology, and pharmacokinetics in infants and children. Bibliographies of articles were also used. STUDY SELECTION: All abstracts and clinical trials were reviewed. DATA EXTRACTION: Study design, population, efficacy, and safety data were retained. DATA SYNTHESIS: RSV—IGIV is an immunoglobulin product with serum neutralizing titers against RSV. It has been shown to reduce hospital stay, admissions, intensive care unit admissions, and mechanical ventilation days in infants and children with RSV pneumonia or bronchiolitis who are younger than 24 months of age and were born prematurely, or have bronchopulmonary dysplasia. RSV—IGIV is well tolerated by infants and children. CONCLUSIONS: RSV—IGIV is an effective prophylactic agent against serious RSV disease in select groups of infants and children.


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