The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), neutralizing antibody and antidrug antibody (ADA) response for TNM001 in infants entering their first RSV season.
This study adopts an adaptive seamless dose selection design and consists of two parts: Part 1 is a phase 2b dose ranging trial which will support to determine the dose for Part 2, the phase 3 trial. The study population includes early and mid-term preterm infants \[gestational age (GA)﹤35 weeks 0 day\] and late preterm infants or full-term infants (≥35 weeks 0 day GA), with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD). A total of approximately 2250 infants will be randomized 2:1 to receive either TNM001 or placebo. All subjects will be followed for 240 days after dosing. This study will be conducted in appropriately 50 sites in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,282
Incidence of medically attended LRTI due to RT-PCR confirmed RSV
Time frame: 150 days post dose
Incidence of hospitalization due to RT-PCR confirmed RSV LRTI
Time frame: 150 days post dose
Occurrence of adverse events (AEs)
Time frame: 240 days post dose
Change in body temperature (celsius)
Time frame: 240 days post dose
Change in blood pressure (mmHg)
Time frame: 240 days post dose
Change in heart rate (beats per minute)
Time frame: 240 days post dose
Change in respiratory rate (breaths per min)
Time frame: 240 days post dose
Number of subjects with clinical significant abnormality in physical examinations
Time frame: 240 days post dose
Serum concentration of single dose TNM001 at pre-specified timepoints
Time frame: 240 days post dose
Serum level of neutralizing antibody to RSV
Time frame: 240 days post dose
Positive rate of anti-drug antibody (ADA) to TNM001 in serum
Time frame: 240 days post dose
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Children's Hospital Capital Institute Pediatrics
Beijing, Beijing Municipality, China
Jiangjin Central Hospital
Chongqing, Chongqing Municipality, China
Xiamen maternal and Child Health Hospital
Xiamen, Fujian, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangdong, Guangdong, China
Guangdong Maternal and Child Health Care Hospital
Guangzhou, Guangdong, China
University of Chinese Academy of Sciense Shenzhen Hospital
Shenzhen, Guangdong, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
LiuZhou People's Hospital
Liuchow, Guangxi, China
Maternity and Child Health Care of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
...and 29 more locations