This study is a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, and immunogenicity of TNM001 in high-risk infants when entering their RSV season. Approximately 201 infants will be randomized in a ratio of 2:1 to receive TNM001 or placebo. All subjects will be followed for 270 days after dosing. This study will be conducted at approximately 20 sites in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
315
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China
Children's Hospital of Chongqing Medical University
Chongqing, Sichuan, China
Incidence of medically attended LRTI due to RT-PCR confirmed RSV
Time frame: 150 days post dose
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