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Trial record 6 of 6 for:    MEDI8897 | RSV Infection

Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China (CHIMES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05110261
Recruitment Status : Recruiting
First Posted : November 5, 2021
Last Update Posted : August 5, 2022
Sponsor:
Collaborator:
IQVIA RDS (Shanghai) Co., Ltd.
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The purpose of this study is to evaluate the Safety and Efficacy of Nirsevimab, in Healthy Preterm and Term Infants in China

Condition or disease Intervention/treatment Phase
Lower Respiratory Tract Infection Drug: Nirsevimab Drug: Placebo Phase 3

Detailed Description:
This is a Phase 3 randomized, double-blind, placebo-controlled, single-dose study to determine if nirsevimab will prevent medically attended RSV-confirmed LRTI in healthy preterm and term infants entering their first RSV season. The population to be enrolled is healthy preterm and term infants > 29 weeks 0 days GA entering their first RSV season, who would not receive RSV prophylaxis based on the American Academy of Pediatrics (AAP) or other local or national guidelines. Approximately 800 subjects will be randomized 2:1 to receive a single IM dose of nirsevimab 50 mg (if weight < 5 kg) or 100 mg (if weight ≥ 5 kg) (N = 530) or placebo (N = 270). Randomization will be stratified by subject age at the time of randomization (≤ 3 months, > 3 to ≤ 6 months, > 6 months), and by GA (< 35 weeks GA, ≥ 35 weeks GA). Enrollment of infants > 6 months of age will be limited to approximately 100. All subjects will be followed through 1 year after dose administration. An independent data monitoring committee will review safety data regularly and make recommendations regarding further study conduct. Around 40 investigational study centres participate in the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Nirsevimab, a Monoclonal Antibody With Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm and Term Infants in China
Actual Study Start Date : November 24, 2021
Estimated Primary Completion Date : May 23, 2025
Estimated Study Completion Date : December 19, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arm Intervention/treatment
Experimental: Nirsevimab
Subjects will be randomized 2:1 to receive a single IM dose of nirsevimab or placebo.
Drug: Nirsevimab
Drug: injection, 100 mg/mL, a single fixed IM dose of 50 mg (if weight < 5 kg) or 100 mg (if weight ≥ 5 kg)on day 1 only.
Other Name: MEDI8897

Placebo Comparator: Placebo
Subjects will be randomized 2:1 to receive a single IM dose of nirsevimab or placebo.
Drug: Placebo
Commercially available 0.9% (w/v) saline (sterile for human use) fixed IM dose of 0.5 mL (if weight <5 kg) or 1.0 mL (if weight >=5 kg)




Primary Outcome Measures :
  1. Incidence of medically attended LRTI due to RT-PCR-confirmed RSV [ Time Frame: Day 1 to Day 151 ]
    The incidence of medically attended RSV LRTI (inpatient and outpatient) through 150 days post dose (ie, during a typical 5-month RSV season) for all infants, based on RSV test results (performed centrally using RT-PCR) and objective protocol-defined LRTI criteria, is the primary endpoint and will be presented by treatment groups. For subjects with multiple events, only the first occurrence will be used in the analysis. RSV LRTI that occurs through 150 days post dose will contribute to the primary efficacy analysis.


Secondary Outcome Measures :
  1. Incidence of RSV Hospitalization RT PCR-confirmed RSV [ Time Frame: Day 1 to Day 151 ]
    To assess the efficacy of nirsevimab in reducing hospitalizations due to protocol-defined LRTI caused by RT-PCR-confirmed RSV, compared to placebo

  2. Safety and tolerability [ Time Frame: Day 1 to Day 361 ]

    Safety and tolerability of Nirsevimab as assessed by the occurrence of all treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE) Safety of Nirsevimab will primarily be assessed and measured by the occurrence of all treatment-emergent AEs and SAEs.

    Other safety assessments will include the occurrence of Adverse Event of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs).


  3. Summary of nirsevimab serum concentrations [ Time Frame: Day 1, Day 15, Day 151 & Day 361 ]
    To evaluate serum concentrations of nirsevimab.

  4. Incidence of ADA to nirsevimab in serum [ Time Frame: Day 1, Day 151 & Day 361 ]
    To evaluate ADA responses to nirsevimab in serum.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   0 Years to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy Chinese preterm and term infants in their first year of life and born ≥ 29 weeks 0 days GA (infants who have an underlying illness such as cystic fibrosis or Down syndrome with no other risk factors are eligible)
  2. Infants who are entering their first RSV season at the time of screening
  3. Written informed consent and any locally required authorization obtained from the subject's parent(s)/legal representative(s) prior to performing any protocol-related procedures, including screening evaluations
  4. Subject's parent(s)/legal representative(s) able to understand and comply with the requirements of the protocol including follow-up visits as judged by the Investigator
  5. Subject is available to complete the follow up period, which will be approximately 1 year after receipt of investigational product

Exclusion Criteria:

  1. Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to investigational product administration
  2. Any history of LRTI or active LRTI prior to, or at the time of, randomization
  3. Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
  4. Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt during the study with the exception of: a) multivitamins and iron; b) infrequent use of over-the-counter (OTC) medications for the systemic treatment of common childhood symptoms (eg, pain relievers) that may be permitted according to the judgment of the Investigator
  5. Any current or expected receipt of immunosuppressive agents including steroids (except for the use of topical steroids according to the judgment of the Investigator)
  6. History of receipt of blood products, or immunoglobulin products, or expected receipt through the duration of the study
  7. Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
  8. Known renal impairment
  9. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
  10. History of CLD/bronchopulmonary dysplasia
  11. Clinically significant congenital anomaly of the respiratory tract
  12. CHD, except for children with uncomplicated CHD (eg, patent ductus arteriosus, small septal defect)
  13. Chronic seizure, or evolving or unstable neurologic disorder
  14. Prior history of a suspected or actual acute life-threatening event
  15. Known immunodeficiency, including human immunodeficiency virus (HIV)
  16. Mother with HIV infection (unless the child has been proven to be not infected)
  17. Any known allergy or history of allergic reaction to immunoglobulin products, blood products, or other foreign proteins, or history of allergic reaction
  18. Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination
  19. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, IV immunoglobulin) or anticipated use during the study
  20. Receipt of any investigational product
  21. Concurrent enrollment in another interventional study
  22. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of study results
  23. Children of employees of the Sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05110261


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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China
Research Site Recruiting
Beijing, China, 100191
Research Site Recruiting
Changde, China, 415003
Research Site Recruiting
Changsha, China, 410005
Research Site Not yet recruiting
Changsha, China, 410008
Research Site Recruiting
Changsha, China, 410008
Research Site Not yet recruiting
Chengdu, China, 610000
Research Site Recruiting
Chengdu, China, 610041
Research Site Recruiting
Guangzhou, China, 510120
Research Site Recruiting
Guangzhou, China, 510150
Research Site Recruiting
Guangzhou, China, 510280
Research Site Recruiting
Hangzhou, China, 310006
Research Site Recruiting
Hangzhou, China, 310013
Research Site Recruiting
Jiaxing, China, 314000
Research Site Recruiting
Kunming, China, 650101
Research Site Not yet recruiting
Langfang, China
Research Site Not yet recruiting
Linfen, China, 041099
Research Site Not yet recruiting
Linfen, China, 41081
Research Site Recruiting
Nanjing, China, 210009
Research Site Recruiting
Ningbo, China, 315012
Research Site Not yet recruiting
Sanmenxia, China, 472000
Research Site Recruiting
Sanya City, China, 572000
Research Site Recruiting
Shantou, China, 515041
Research Site Recruiting
Shaoxing, China, 311800
Research Site Not yet recruiting
Shenzhen, China, 518053
Research Site Recruiting
Shenzhen, China, 518106
Research Site Not yet recruiting
Suzhou, China, 215002
Research Site Not yet recruiting
Tangshan, China, 63003
Research Site Recruiting
Tianjin, China, 300074
Research Site Recruiting
Tianjin, China, 300201
Research Site Recruiting
Tonghua, China, 134000
Research Site Recruiting
Wenzhou, China, 325027
Research Site Recruiting
Wuxi, China, 214023
Research Site Not yet recruiting
Xiamen, China, 361003
Research Site Not yet recruiting
Xinxiang, China, 453000
Research Site Not yet recruiting
Zhengzhou, China, 450018
Research Site Recruiting
Zhongshan, China, 528400
Sponsors and Collaborators
AstraZeneca
IQVIA RDS (Shanghai) Co., Ltd.
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05110261    
Other Study ID Numbers: D5290C00006
First Posted: November 5, 2021    Key Record Dates
Last Update Posted: August 5, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Respiratory Syncytial Viral (RSV)
Efficacy
Safety
Nirsevimab
healthy Chinese preterm and term infants
Additional relevant MeSH terms:
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Respiratory Tract Infections
Infections
Respiratory Tract Diseases