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The problem
Intervention: Clesrovimab, a long-acting monoclonal antibody, administered as a single 105-mg dose in RSV season 1 (with placebo at day 28) and 210-mg dose in RSV season 2, compared to monthly palivizumab injections
Who it was tested with: 997 infants at increased risk for severe RSV disease (mean age 2.6 months); 500 male (50.2%); included those with prematurity, chronic lung disease of prematurity, or hemodynamically significant congenital heart disease.
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"randomized, partially masked, palivizumab-controlled, phase 3 clinical trial" with "997 infants" randomly assigned to clesrovimab or palivizumab and followed through 2 RSV seasons. The randomized comparison in season 1 with a control group meets the criteria for an experimental design, though season 2 does not have a comparison group.
Season 2 used an open-label design without a control group, limiting comparative conclusions. The study measures medically attended infections rather than all RSV infections, which may underestimate disease burden. Generalizability to populations outside the study's 27 countries is uncertain.
Across countries and designs
6 studies · 17 countries
