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A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TNM001
placebo
Sponsored by
Zhuhai Trinomab Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Syncytial Virus Infections

Eligibility Criteria

0 Years - 1 Year (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 1. Early and mid-term preterm infants (<35 weeks 0 day GA) and late preterm infants or full-term infants (≥35 weeks 0 day GA) under 1 year of age, with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD)，who are entering their first RSV season at the time of screening. Exclusion Criteria: 1. Any fever (> 38.0°C) or acute illness within 7 days prior to randomization 2. History of RSV infection or active RSV infection prior to, or at the time of, randomization 3. Drug medication prior to randomization or expected to be treated by medicines during the study period. 4. Currently receiving or expected to receive immunosuppressive therapy during the study period. 5. Renal impairment or hepatic dysfunction 6. Nervous system disease or neuromuscular disease 7. Prior history of a suspected or actual acute life-threatening event 8. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded. 9. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period. 10.Receipt of RSV vaccine or mAb

Sites / Locations

  • Peking University Third Hospital
  • Children's Hospital Capital Institute Pediatrics
  • Jiangjin Central Hospital
  • Xiamen maternal and Child Health Hospital
  • The Third Affiliated Hospital of Guangzhou Medical University
  • Guangdong Maternal and Child Health Care Hospital
  • University of Chinese Academy of Sciense Shenzhen Hospital
  • Affiliated Hospital of Guilin Medical University
  • LiuZhou People's Hospital
  • Maternity and Child Health Care of Guangxi Zhuang Autonomous Region
  • HaiNan Women and Children's Medical Center
  • Hebei Petro China Central Hospital
  • The Fourth Hospital of Hebei Medical University
  • The Second Hospital of HeBei Medical University (HBMU)
  • Tangshan Maternal and Child Health Hospitaltangshan Maternal and Child Health Hospital
  • Sanmenxia Central Hospital
  • Xinxiang First People's Hospital
  • Henan (Zhengzhou) Children's Hospital
  • Renmin Hospital of Wuhan University
  • The Central Hospital of Wuhan
  • The First People'S Hospital of Changde City
  • The Maternal and Child Health Hospital of Hunan Province
  • Xiangya Hospital Central South University
  • The Third Xiangya Hospital of Central South University
  • The Second Hospital University of South China
  • Loudi Central Hospital
  • The First Affiliated Hospital of Shaoyang University
  • Jiangxi Maternal and Child Health Hospital
  • Children's Hospital Affiliated to Shandong University
  • The affiliated children'shospital fudan university
  • Linfen Central Hospital
  • Linfen People's Hospital
  • Yuncheng Central Hospital
  • Chengdu Women's and Children's Central Hospital
  • West China Second University Hospital, Sichuan University
  • Children's Hospital of Chongqing Medical University
  • Mianyang Peoples Hospital
  • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine/Hangzhou First People's Hospital
  • Ningbo Women&Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TNM001

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Incidence of medically attended LRTI due to RT-PCR confirmed RSV

Secondary Outcome Measures

Incidence of hospitalization due to RT-PCR confirmed RSV LRTI
Occurrence of adverse events (AEs)
Change in body temperature (celsius)
Change in blood pressure (mmHg)
Change in heart rate (beats per minute)
Change in respiratory rate (breaths per min)
Number of subjects with clinical significant abnormality in physical examinations
Serum concentration of single dose TNM001 at pre-specified timepoints
Serum level of neutralizing antibody to RSV
Positive rate of anti-drug antibody (ADA) to TNM001 in serum

Full Information

First Posted
September 10, 2023
Last Updated
October 11, 2023
Sponsor
Zhuhai Trinomab Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06083623
Brief Title
A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants
Official Title
A Randomized, Double-blind, Placebo-controlled and Parallel Group Adaptive Phase 2b/3 Trial to Evaluate the Efficacy and Safety of TNM001 Injection for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants Under One Year of Age
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 6, 2023 (Anticipated)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhuhai Trinomab Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TNM001
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
TNM001
Intervention Description
single dose intramuscular injection
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
single dose intramuscular injection
Primary Outcome Measure Information:
Title
Incidence of medically attended LRTI due to RT-PCR confirmed RSV
Time Frame
150 days post dose
Secondary Outcome Measure Information:
Title
Incidence of hospitalization due to RT-PCR confirmed RSV LRTI
Time Frame
150 days post dose
Title
Occurrence of adverse events (AEs)
Time Frame
240 days post dose
Title
Change in body temperature (celsius)
Time Frame
240 days post dose
Title
Change in blood pressure (mmHg)
Time Frame
240 days post dose
Title
Change in heart rate (beats per minute)
Time Frame
240 days post dose
Title
Change in respiratory rate (breaths per min)
Time Frame
240 days post dose
Title
Number of subjects with clinical significant abnormality in physical examinations
Time Frame
240 days post dose
Title
Serum concentration of single dose TNM001 at pre-specified timepoints
Time Frame
240 days post dose
Title
Serum level of neutralizing antibody to RSV
Time Frame
240 days post dose
Title
Positive rate of anti-drug antibody (ADA) to TNM001 in serum
Time Frame
240 days post dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Early and mid-term preterm infants (<35 weeks 0 day GA) and late preterm infants or full-term infants (≥35 weeks 0 day GA) under 1 year of age, with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD)，who are entering their first RSV season at the time of screening. Exclusion Criteria: 1. Any fever (> 38.0°C) or acute illness within 7 days prior to randomization 2. History of RSV infection or active RSV infection prior to, or at the time of, randomization 3. Drug medication prior to randomization or expected to be treated by medicines during the study period. 4. Currently receiving or expected to receive immunosuppressive therapy during the study period. 5. Renal impairment or hepatic dysfunction 6. Nervous system disease or neuromuscular disease 7. Prior history of a suspected or actual acute life-threatening event 8. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded. 9. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period. 10.Receipt of RSV vaccine or mAb
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Wang
Phone
+86 0756 7263999
Email
emma.wang@trinomab.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shiru Zhao
Phone
+86 0756 7263999
Email
zhaoshiru@trinomab.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanmin Liu, MD
Organizational Affiliation
West China Second Hospital, Sichuan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Enmei Liu, MD
Organizational Affiliation
Children's Hospital of Chongqing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ying Wang
Organizational Affiliation
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tongyan Han
Phone
+86 13520695016
Email
tongyanhan@qq.com
Facility Name
Children's Hospital Capital Institute Pediatrics
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Cao
Phone
+86 13910610319
Email
caoling9919@163.com
Facility Name
Jiangjin Central Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Fu
Phone
+86 15123226406
Email
3249776538@qq.com
Facility Name
Xiamen maternal and Child Health Hospital
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tong Shen
Phone
+86 13950155429
Email
1605122429@qq.com
Facility Name
The Third Affiliated Hospital of Guangzhou Medical University
City
Guangdong
State/Province
Guangdong
ZIP/Postal Code
510150
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fan Wu
Phone
+86 18127862115
Email
gdwufan@126.com
Facility Name
Guangdong Maternal and Child Health Care Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
511442
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jieling Wu
Phone
+86 13600456180
Email
jieling3861@163.com
Facility Name
University of Chinese Academy of Sciense Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhui Zhang
Phone
+86 137 9826 5975
Email
zhang.wenhui@hotmail.com
Facility Name
Affiliated Hospital of Guilin Medical University
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
541001
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Peng
Phone
+86 15907738875
Email
630464076@qq.com
Facility Name
LiuZhou People's Hospital
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545006
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingjiang Long
Phone
+86 13627725688
Email
54229359@qq.com
Facility Name
Maternity and Child Health Care of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530002
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jielin Chen
Phone
+86 13517666951
Email
313372046@qq.com
Facility Name
HaiNan Women and Children's Medical Center
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570312
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Xiang
Phone
+86 18608981299
Email
xiangwei8@163.com
Facility Name
Hebei Petro China Central Hospital
City
Langfang
State/Province
Hebei
ZIP/Postal Code
065000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinjian Liu
Phone
+86 13930601503
Email
drliu7285@163.com
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijia Zhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lian Jiang
Phone
+86 13831117651
Email
jianglianerke@163.com
Facility Name
The Second Hospital of HeBei Medical University (HBMU)
City
Shijia Zhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiqing Zhang
Phone
+86 15803210627
Email
777yyy@sina.cn
First Name & Middle Initial & Last Name & Degree
Xiaoning Wang
Phone
+86 13833118294
Email
wangxn9611@163.com
Facility Name
Tangshan Maternal and Child Health Hospitaltangshan Maternal and Child Health Hospital
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuying Wang
Phone
+86 13932537139
Email
1299149713@qq.com
Facility Name
Sanmenxia Central Hospital
City
Sanmenxia
State/Province
Henan
ZIP/Postal Code
472000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunying Ma
Phone
+86 15978336266
Email
1373063423@qq.com
Facility Name
Xinxiang First People's Hospital
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunhui Zhang
Phone
+86 15670505357
Email
2429984525@qq.com
Facility Name
Henan (Zhengzhou) Children's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuhong Jin
Phone
+86 13525552263
Email
doctorjin939@126.com
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baozhen Yao
Phone
+86 13986147892
Email
professoryao@aliyun.com
Facility Name
The Central Hospital of Wuhan
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Jiang
Phone
+86 15927526319
Email
Jhred99@163.com
Facility Name
The First People'S Hospital of Changde City
City
Changde
State/Province
Hunan
ZIP/Postal Code
415000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minghui Wang
Phone
+86 13607367063
Email
Wmh185566@163.com
Facility Name
The Maternal and Child Health Hospital of Hunan Province
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangfeng Yang
Phone
13875962130
Email
136826783@qq.com
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangrong Zheng
Phone
+86 13508484326
Email
zxr_168@126.com
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minghua Yang
Phone
+86 13973135843
Email
yamahua123@163.com
Facility Name
The Second Hospital University of South China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingpeng Hu
Phone
+86 13357248086
Email
pengpeng000923@163.com
Facility Name
Loudi Central Hospital
City
Loudi
State/Province
Hunan
ZIP/Postal Code
417099
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiran Liu
Phone
+86 13973837171
Email
275866565@qq.com
Facility Name
The First Affiliated Hospital of Shaoyang University
City
Shaoyang
State/Province
Hunan
ZIP/Postal Code
422000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinping Peng
Phone
+86 13975951076
Email
13975951076@139.com
Facility Name
Jiangxi Maternal and Child Health Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingxiong Zhu
Phone
+86 15979003000
Email
zhuqingxiong2000@163.com
Facility Name
Children's Hospital Affiliated to Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250022
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuling Han
Phone
+86 13969098010
Email
evelyn.han@163.com
Facility Name
The affiliated children'shospital fudan university
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Libo Wang
Phone
+86 18017590801
Email
wxy1008@126.com
Facility Name
Linfen Central Hospital
City
Linfen
State/Province
Shanxi
ZIP/Postal Code
041000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiangli Xi
Phone
+86 13753758090
Email
592881121@qq.com
Facility Name
Linfen People's Hospital
City
Linfen
State/Province
Shanxi
ZIP/Postal Code
041000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiangchuan Zhu
Phone
+86 13303576606
Email
13303576606@163.com
Facility Name
Yuncheng Central Hospital
City
Yuncheng
State/Province
Shanxi
ZIP/Postal Code
044000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihe Wang
Phone
+86 15503599191
Email
ycszxyyerke@163.com
First Name & Middle Initial & Last Name & Degree
Fengli Zhao
Phone
+86 18235960066
Email
zhaoflhh@163.com
Facility Name
Chengdu Women's and Children's Central Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yulei Yu
Phone
+86 15388101587
Email
48533259@qq.com
Facility Name
West China Second University Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanmin Liu
Phone
+86 18180609009
Email
Hanmin@vip.163.com
First Name & Middle Initial & Last Name & Degree
Qin Qin
Phone
+86 18180603576
Email
908929936@qq.com
Facility Name
Children's Hospital of Chongqing Medical University
City
Chongqing
State/Province
Sichuan
ZIP/Postal Code
404100
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EnMei Liu, MD
Phone
13368070773
Email
emliu186@126.com
Facility Name
Mianyang Peoples Hospital
City
Mianyang
State/Province
Sichuan
ZIP/Postal Code
621000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Li
Phone
+86 13890190821
Email
1692508220@qq.com
Facility Name
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine/Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunming Jiang
Phone
+86 13606610578
Email
cm_jiang@126.com
Facility Name
Ningbo Women&Children's Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315012
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hehe Chen
Phone
+86 13605883884
Email
12974734@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants

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