The primary objective of this study is to compare the safety and efficacy of MEDI-493 (15mg/kg) to placebo when administered monthly by intramuscular injection for the reduction of the incidence of RSV hospitalization among infants born prematurely and infants with bronchopulmonary dysplasia (BPD). The secondary objectives of the study are to determine the effect of monthly MEDI-493 prophylaxis compared to placebo on RSV hospitalization parameters: total RSV hospital days, total RSV hospital days with increased supplemental oxygen requirement, total RSV hospital days with moderate or severe lower respiratory tract infection (LRI score >/= 3), frequency and total RSV-associated ICU days, frequency and total days of RSV-associated mechanical ventilation, incidence and total days of hospitalization for non-RSV respiratory disease and any respiratory disease and hospitalization for any cause, incidence of otitis media.

Project Start
1997-12-01
Project End
1998-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
34
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Baylor College of Medicine
Department
Type
DUNS #
074615394
City
Houston
State
TX
Country
United States
Zip Code
77030
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