Safety, efficacy and pharmacokinetics of palivizumab in off-label neonates, infants, and young children at risk for serious respiratory syncytial virus infection: a multicenter phase II clinical trial

• Published in: The Lancet regional health. Western Pacific Vol. 39; p. 100847
• Main Authors: Mori, Masaaki, Yoshizaki, Kanako, Watabe, Shinichi, Ishige, Mika, Hinoki, Akinari, Kondo, Takuya, Taguchi, Tomoaki, Hasegawa, Hisaya, Hatata, Tomoko, Tanuma, Naoyuki, Kirino, Kosuke, Hirakawa, Akihiro, Naruto, Takuya, Imai, Minoru, Koike, Ryuji, Hosoi, Kenichiro, Kusuda, Satoshi
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.10.2023; Elsevier
• Subjects: Airway stenosis; Congenital esophageal atresia; Efficacy; Inherited metabolic disease; Neuromuscular disease; Palivizumab; Pediatric patient; Pulmonary hypoplasia; Respiratory syncytial virus infection; Inherited metabolic disease; Palivizumab; Respiratory syncytial virus infection; Neuromuscular disease; Pulmonary hypoplasia; Efficacy; Pediatric patient; Airway stenosis; Congenital esophageal atresia

Pediatric patients with certain rare diseases are at increased risk of severe respiratory syncytial virus (RSV) infection. However, the prophylactic use of anti-RSV antibody (palivizumab) in these patients is not indicated at present in Japan. This first-in-the-world multicenter, uncontrolled, open-...