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Sanofi infant syncytial virus nasal spray vaccine approved for clinical use in China

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On June 3rd, Southern Finance and Economics reported that Sanofi announced that its attenuated live vaccine for respiratory syncytial virus (RSVt vaccine, SP0125) for infants and young children has been approved for clinical research by the Drug Evaluation Center (CDE) of the National Medical Products Administration (NMPA) in China. This is the first children's vaccine in China to participate in international multicenter clinical trials (MRCT) since the implementation of the new version of the Drug Registration Management Measures in 2020. At the same time, the RSVt vaccine is also the world's first vaccine designed for infants and young children to prevent diseases caused by respiratory syncytial virus (RSV), providing protection for infants and young children aged 6 to 24 months. It is understood that participants in this study will randomly receive 2 doses of vaccine or placebo in a 1:1 ratio, with a 56 day interval between the two doses, administered intranasally. This study does not include infants and young children with weakened immunity, and the effectiveness of the vaccine on lower respiratory tract disease (LRTD) and upper respiratory tract disease (URTD) will be evaluated separately. (21st Century Business Herald)
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