7%) occurring within 14 days post dose. The majority of cases were mild to moderate in intensity. 3% within 7 days post dose, respectively. Injection site reactions were non-serious. 4). Adverse reactions reported from controlled clinical trials are classified by MedDRA System Organ Class (SOC).
Within each SOC, preferred terms are arranged by decreasing frequency and then by decreasing seriousness. Frequencies of occurrence of adverse reactions are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Table 1:
Adverse reactions MedDRA SOC MedDRA Preferred Term Frequency Immune system disorders Hypersensitivitya Not known Skin and subcutaneous tissue disorders Rashb Uncommon Injection site reactionc UncommonGeneral disorders and administration site conditions Pyrexia Uncommon a Adverse reaction from spontaneous reporting.
b Rash was defined by the following grouped preferred terms: rash, rash maculo-papular, rash macular. c Injection site reaction was defined by the following grouped preferred terms: injection site reaction, injection site pain, injection site induration, injection site oedema, injection site swelling.
Infants at higher risk for severe RSV disease in their first season Safety was evaluated in MEDLEY in 918 infants at higher risk for severe RSV disease, including 196 extremely preterm infants (GA <29 weeks) and 306 infants with chronic lung disease of prematurity, or haemodynamically significant congenital heart disease entering their first RSV season, who received nirsevimab (n=614) or palivizumab (n=304).
The safety profile of nirsevimab in infants who received nirsevimab in their first RSV season was comparable to the palivizumab comparator and consistent with the safety profile of nirsevimab in term and preterm infants GA ≥29 weeks (D5290C00003 and MELODY).
Children who remain vulnerable to severe RSV disease in their second season Safety was evaluated in MEDLEY in 220 children with chronic lung disease of prematurity or haemodynamically significant congenital heart disease who received nirsevimab or palivizumab in their first RSV season and went on to receive nirsevimab entering their second RSV season (180 subjects received nirsevimab in both Season 1 and 2, 40 received palivizumab in Season 1 and nirsevimab in Season 2).
The safety profile of nirsevimab in children who received nirsevimab in their second RSV season was consistent with the safety profile of nirsevimab in term and preterm infants GA ≥29 weeks (D5290C00003 and MELODY). Safety was also evaluated in MUSIC, an open label, uncontrolled, single dose trial in 100 immunocompromised infants and children ≤24 months, who received nirsevimab in their first or second RSV season.
This included subjects with at least one of the following conditions: immunodeficiency (combined, antibody, or other etiology) (n=33); systemic high-dose corticosteroid therapy (n=29); organ or bone marrow transplantation (n=16); receiving immunosuppressive chemotherapy (n=20); other immunosuppressive therapy (n=15), and HIV infection (n=8).
The safety profile of nirsevimab was consistent with that expected for a population of immunocompromised children and with the safety profile of nirsevimab in term and preterm infants GA ≥29 weeks (D5290C00003 and MELODY). The safety profile of nirsevimab in children during their second RSV season was consistent with the safety profile of nirsevimab observed during their first RSV season.
Term and Preterm Infants entering their first RSV season Safety of nirsevimab was also evaluated in HARMONIE, a randomised open-label multicentre trial in 8 034 term and preterm infants (GA ≥29 weeks) entering their first RSV season (not eligible for palivizumab), who received nirsevimab (n=4 016) or no intervention (n=4 018) for the prevention of respiratory syncytial virus lower respiratory tract infection (RSV LRTI) hospitalisation.
The safety profile of nirsevimab administered in the first RSV season was consistent with the safety profile of nirsevimab in the placebo-controlled trials (D5290C00003 and MELODY). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.