Table 2.
Most commonly observed Aes (reported in ≥10% of any treatment group during the first RSV season) through 360 days post-dose by preferred term in healthy term and preterm infants born ≥29 wGA. a Infants with CHD/CLD or preterm infants born ≤35 weeks 0 days GA without CHD/CLD, and children with CHD/CLD entering their second RSV season b.
| Healthy Term and Preterm Infants Born ≥29 wGA a | Infants Eligible for Palivizumab Entering Their First RSV Season |
Children with CHD/CLD Entering Their Second RSV Season b |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Preterm Infants Born ≤35 Weeks 0 Days GA without CHD or CLD |
Infants with CHD/CLD | ||||||||
| Preferred Term, n (%) | Nirsevimab (n = 2570) |
Placebo (n = 1284) |
Nirsevimab (n = 406) |
Palivizumab (n = 206) |
Nirsevimab (n = 208) |
Palivizumab (n = 98) |
Nirsevimab/ Nirsevimab (n = 180) |
Palivizumab/ Nirsevimab (n = 40) |
Palivizumab/ Palivizumab (n = 42) |
| Upper respiratory tract infection |
869 (33.8) | 417 (32.5) | 110 (27.1) | 56 (27.2) | 39 (18.8) | 23 (23.5) | 48 (26.7) | 8 (20.0) | 9 (21.4) |
| Nasopharyngitis | 523 (20.4) | 292 (22.7) | 36 (8.9) | 20 (9.7) | 21 (10.1) | 19 (19.4) | 26 (14.4) | 7 (17.5) | 9 (21.4) |
| Pyrexia | 348 (13.5) | 152 (11.8) | 54 (13.3) | 33 (16.0) | 29 (13.9) | 10 (10.2) | 23 (12.8) | 9 (22.5) | 6 (14.3) |
| Gastroenteritis | 284 (11.1) | 128 (10.0) | 17 (4.2) | 14 (6.8) | 8 (3.8) | 2 (2.0) | 14 (7.8) | 2 (5.0) | 3 (7.1) |
| Dermatitis diaper |
271 (10.5) | 126 (9.8) | 17 (4.2) | 3 (1.5) | 11 (5.3) | 3 (3.1) | 8 (4.4) | 0 | 1 (2.4) |
| Rhinitis | 252 (9.8) | 126 (9.8) | 48 (11.8) | 27 (13.1) | 27 (13.0) | 13 (13.3) | 29 (16.1) | 6 (15.0) | 6 (14.3) |
| Constipation | 112 (4.4) | 55 (4.3) | 16 (3.9) | 10 (4.9) | 21 (10.1) | 10 (10.2) | 5 (2.8) | 2 (5.0) | 2 (4.8) |
Participants with multiple events in the same preferred term were counted once in each of those preferred terms. Participants with events in more than one preferred term were counted once in each of those preferred terms. a Includes infants from Phase 2b weighing < 5 kg and the full MELODY enrollment cohort. b Before the second season, children with CHD/CLD randomized to nirsevimab in the first season received a single IM dose of 200 mg nirsevimab followed by 4× once-monthly IM doses of placebo (nirsevimab/nirsevimab), and those randomized to palivizumab in the first season were re-randomized 1:1 to either a single IM dose of 200 mg nirsevimab followed by 4× once-monthly IM doses of placebo (palivizumab/nirsevimab) or 5× once-monthly IM doses of palivizumab (15 mg/kg per dose) (palivizumab/palivizumab). Abbreviations: AE, adverse event; CHD, congenital heart disease; CLD, congenital lung disease; GA, gestational age; IM, intramuscular; RSV, respiratory syncytial virus; wGA, weeks’ gestational age.