SAFETY OF CLESROVIMAB IN INFANTS AT INCREASED RISK FOR SEVERE RSV DISEASE IN RSV SEASON 1: SUBGROUP ANALYSIS OF A PHASE 3 TRIAL (MK- 1654-007, SMART) (ID 663)
MSD UK
Abstract
Background
The ongoing Phase 3 SMART trial (MK-1654-007, NCT04938830) is evaluating safety and tolerability of clesrovimab in infants at increased risk for severe RSV disease. This interim analysis focuses on safety across predefined infant subgroups based on participant condition, age, and weight in RSV season 1.
Methods
Palivizumab-eligible infants entering their first RSV season were randomized 1:1 to receive clesrovimab (105 mg) or monthly palivizumab. Safety and tolerability were assessed using reported adverse event (AE) rates by subgroup, including drug-related, solicited injection site, solicited systemic and serious AEs (SAEs) in all randomized participants receiving study intervention.
Results
Proportions of participants who experienced any AEs were generally comparable between intervention groups across subgroups (Table 1). No SAEs were related to study intervention. Subgroup analyses by age and weight group will also be presented.
Conclusions
Safety results were generally comparable between the clesrovimab and the palivizumab groups across predefined subgroup categories in RSV season 1, consistent with the overall population. Limitations include small numbers of participants in certain subgroups.
Funding: Study was funded by Merck & Co., Inc., Rahway, NJ, USA.
Conflicts of interest: Authors are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and may hold stock or stock options in Merck & Co., Inc., Rahway, NJ, USA.
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