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

NCT05110261 | Completed Phase 3 DMC

• 2 other identifiers: D5290C000062021-005075-38
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 30

Brief Summary

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

Conditions

Lower Respiratory Tract Infection

Keywords

Respiratory Syncytial Viral (RSV); Efficacy; Safety; Nirsevimab; healthy Chinese preterm and term infants

Outcome Measures

Primary Outcomes (1)

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

  Incidence of all medically attended LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV through 150 days after dosing (ie, during a typical 5-month RSV season)

  Day 1 to Day 151

Secondary Outcomes (5)

• Incidence of LRTI hospitalization due to RT-PCR confirmed RSV

  Day 1 to Day 151

• Incidence of medically attended LRTI (protocol defined) due to RT-PCR-confirmed RSV

  Day 1 to Day 151

• Safety and tolerability

  Day 1 to Day 361

• Summary of nirsevimab serum concentrations

  Day 1, Day 15, Day 151 & Day 361

• Incidence of ADA to nirsevimab in serum

  Day 1, Day 151 & Day 361

Study Arms (2)

Nirsevimab

EXPERIMENTAL

Subjects will be randomized 2:1 to receive a single IM dose of nirsevimab or placebo.

Drug: Nirsevimab

Placebo

PLACEBO COMPARATOR

Subjects will be randomized 2:1 to receive a single IM dose of nirsevimab or placebo.

Drug: Placebo

Interventions

Nirsevimab DRUG

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.

Also known as: MEDI8897

Nirsevimab

Placebo DRUG

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)

Placebo

Eligibility Criteria

• Age: 0 Years - 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)
• Infants who are entering their first RSV season at the time of screening
• 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
• 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
• Subject is available to complete the follow up period, which will be approximately 1 year after receipt of investigational product

You may not qualify if:

• Any fever (≥ 100.4°F \[≥ 38.0°C\], regardless of route) or acute illness within 7 days prior to investigational product administration
• Any history of LRTI or active LRTI prior to, or at the time of, randomization
• Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
• 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
• Any current or expected receipt of immunosuppressive agents including steroids (except for the use of topical steroids according to the judgment of the Investigator)
• History of receipt of blood products, or immunoglobulin products, or expected receipt through the duration of the study
• Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
• Known renal impairment
• Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
• History of CLD/bronchopulmonary dysplasia
• Clinically significant congenital anomaly of the respiratory tract
• CHD, except for children with uncomplicated CHD (eg, patent ductus arteriosus, small septal defect)
• Chronic seizure, or evolving or unstable neurologic disorder
• Prior history of a suspected or actual acute life-threatening event
• Known immunodeficiency, including human immunodeficiency virus (HIV)

Sponsors & Collaborators

• AstraZeneca: lead
• IQVIA RDS Inc.: collaborator

Study Sites (30)

Research Site

Beijing, 100191, China

Location

Research Site

Changde, 415000, China

Location

Research Site

Changsha, 410005, China

Location

Research Site

Changsha, 410008, China

Location

Research Site

Chengdu, 610000, China

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Chengdu, 610041, China

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Guangzhou, 510120, China

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Guangzhou, 510150, China

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Guangzhou, 510280, China

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Hangzhou, 310006, China

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Hangzhou, 310013, China

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Jiaxing, 314000, China

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Kunming, 650101, China

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Langfang, 065000, China

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Linfen, 041099, China

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Linfen, 41081, China

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Nanjing, 210009, China

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Ningbo, 315012, China

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Sanmenxia, 472000, China

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Sanya, 572000, China

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Shantou, 515041, China

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Shaoxing, 311800, China

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Shenzhen, 518106, China

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Suzhou, 215002, China

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Tangshan, 63003, China

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Tianjin, 300201, China

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Wenzhou, 325027, China

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Xinxiang, 453000, China

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Zhengzhou, 450018, China

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Research Site

Zhongshan, 528400, China

Location

MeSH Terms

Interventions

nirsevimab

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 5, 2021
• Study Start: November 24, 2021
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

CN (30)