![\"\"](\"https:\/\/www.merckvaccines.com\/enflonsia\/wp-content\/uploads\/sites\/276\/2026\/03\/CAT_Hero-Image_Desktop_Safety-Tolerability_RGB.jpg?w=1488\")
<\/picture>ENFLONSIATM<\/sup> (clesrovimab-cfor) showed a consistent safety profile across infant populations<\/strong>1<\/sup><\/strong><\/mark><\/h1><\/p>
<\/div><\/div><\/div><\/div><\/div><\/div><\/div>\n\n\n\n\n<\/div>\n\n\n\nAdverse reactions reported at an incidence higher than placebo (CLEVER Trial 004)1<\/sup><\/th><\/tr><\/thead>Adverse reaction<\/strong><\/td>ENFLONSIA
(N=2,412)a<\/sup>
(%)<\/strong><\/td>Placebo
(N=1,202)a<\/sup>
(%)<\/strong><\/td><\/tr>Injection-site erythemab<\/sup><\/strong><\/td>3.8<\/strong> <\/td>3.3<\/strong><\/td><\/tr>Injection-site swellingb<\/sup><\/strong><\/td>2.7<\/strong><\/td>2.6<\/strong><\/td><\/tr>Rashc<\/sup><\/strong><\/td>2.3<\/strong><\/td>1.9<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\nThese were the most commonly reported adverse reactions.<\/p>\n\n\n\n
<\/div>\n\n\n\na<\/sup>Sample size reflects the number of participants included in the safety analysis population.<\/p>\n\n\n\n<\/div>\n\n\n\nb<\/sup>Occurring within 5 days post-dose; Solicited on Day 1 through Day 5 post dose using an electronic diary device.<\/p>\n\n\n\n<\/div>\n\n\n\nc<\/sup>Occurring within 14 days post-dose; Defined by the following grouped preferred terms: rash, rash erythematous, rash macular, rash papular, rash maculo-papular, rash vesicular, rash exfoliative, dermatitis allergic, drug eruption, and toxic skin eruption.<\/p>\n\n\n\n<\/div>\n\n\n\nMost adverse reactions (\u226597%) were mild or moderate in severity.<\/p>\n\n\n\n
<\/div>\n\n\n\n\n\n\n\n\nInfants at increased risk of severe RSV LRT disease in the SMART 007 trial entering their first RSV season had a similar safety profile with ENFLONSIA compared to healthy infants in the CLEVER 004 trial1,2<\/sup><\/h2><\/div>\n\n\n\n<\/div>\n\n\n\n\n\n\nCLEVER 004 study design<\/a><\/div>\n<\/div>\n\n\n\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div><\/div>\n\n\n\n<\/div>\n\n\n\nStudy design (SMART 007 trial):<\/h3><\/div>\n\n\n\n<\/div>\n\n\n\nAn international, randomized, partially-blind, palivizumab-controlled, Phase 3 study evaluated the safety (primary endpoint) and efficacy of ENFLONSIA in infants at increased risk of severe RSV disease. Infants \u22641 year of age and entering their first RSV season were included if they were early (<29 weeks gestational age) or moderate preterm infants ( \u226529 to \u226435 weeks gestational age), or had CLD of prematurity or hemodynamically significant CHD of any gestational age. Participants received a single 105 mg IM dose of ENFLONSIA (N=446) followed by a dose of placebo one month later or 3 to 5 monthly doses of 15 mg\/kg palivizumab (N=450).2<\/sup><\/span><\/p>\n\n\n\n<\/div>\n\n\n\n\n\n\n<\/i><\/div>See clinical data for ENFLONSIA<\/h3>
<\/a><\/p><\/div><\/i><\/div><\/div><\/div><\/div>\n<\/div>\n\n\n\n\n<\/i><\/div>Frequently asked questions<\/h3>
Adverse reactions reported at an incidence higher than placebo (CLEVER Trial 004)1<\/sup><\/th><\/tr><\/thead>| Adverse reaction<\/strong><\/td> | ENFLONSIA | (N=2,412)a<\/sup> (%)<\/strong><\/td> Placebo | (N=1,202)a<\/sup> (%)<\/strong><\/td><\/tr> Injection-site erythemab<\/sup><\/strong><\/td> | 3.8<\/strong> <\/td> | 3.3<\/strong><\/td><\/tr> | Injection-site swellingb<\/sup><\/strong><\/td> | 2.7<\/strong><\/td> | 2.6<\/strong><\/td><\/tr> | Rashc<\/sup><\/strong><\/td> | 2.3<\/strong><\/td> | 1.9<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n | These were the most commonly reported adverse reactions.<\/p>\n\n\n\n <\/div>\n\n\n\n a<\/sup>Sample size reflects the number of participants included in the safety analysis population.<\/p>\n\n\n\n b<\/sup>Occurring within 5 days post-dose; Solicited on Day 1 through Day 5 post dose using an electronic diary device.<\/p>\n\n\n\n c<\/sup>Occurring within 14 days post-dose; Defined by the following grouped preferred terms: rash, rash erythematous, rash macular, rash papular, rash maculo-papular, rash vesicular, rash exfoliative, dermatitis allergic, drug eruption, and toxic skin eruption.<\/p>\n\n\n\n Most adverse reactions (\u226597%) were mild or moderate in severity.<\/p>\n\n\n\n An international, randomized, partially-blind, palivizumab-controlled, Phase 3 study evaluated the safety (primary endpoint) and efficacy of ENFLONSIA in infants at increased risk of severe RSV disease. Infants \u22641 year of age and entering their first RSV season were included if they were early (<29 weeks gestational age) or moderate preterm infants ( \u226529 to \u226435 weeks gestational age), or had CLD of prematurity or hemodynamically significant CHD of any gestational age. Participants received a single 105 mg IM dose of ENFLONSIA (N=446) followed by a dose of placebo one month later or 3 to 5 monthly doses of 15 mg\/kg palivizumab (N=450).2<\/sup><\/span><\/p>\n\n\n\n <\/a><\/p><\/div> |
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