Sanofi (EPA: SAN), a major French multinational pharmaceutical company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for SP0125, a nasal spray respiratory syncytial virus (RSV) attenuated live vaccine intended for use in infants and young children.
RSV is among the most prevalent viral pathogens leading to acute upper respiratory infection (AURI) in infants and young children. Sanofi’s SP0125 is the world’s first RSV vaccine specifically designed for infants, offering protection for children aged 6 to 24 months. Global Phase I/II clinical trials have demonstrated that two doses of SP0125 have a tolerability profile similar to placebo and can elicit an antibody response in 93% of cases. In December 2020, SP0125 was granted Fast Track designation in the U.S., followed by Priority Medicines (PRIME) status in the EU in December 2023.
The approved study is a global, randomized, blinded, placebo-controlled, multicenter Phase III clinical trial. It aims to evaluate the efficacy, immunogenicity, and safety of SP0125 in infants and small children aged 6 to 22 months, irrespective of their RSV basal serum antibody status. Participants will be randomly assigned to receive either two doses of the vaccine or placebo in a 1:1 ratio, with a 56-day interval between doses, administered via the nasal route. The study will exclude infants with compromised immunity. The vaccine’s effectiveness against lower respiratory tract disease (LRTD) and upper respiratory tract disease (URTD) will be assessed separately.- Flcube.com
