A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab

NCT06042049 | Completed Phase 3 Results

• 2 other identifiers: D5290C000092025-000021-13
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged ≤12 months. Study details include

• The study duration is approximately 21 months with a 2-month enrollment period.
• Study intervention is 2 doses administered 5- 6 months apart.
• The study has 5 or 6 site visits and several telephone contacts with a 2 or 4 week interval.

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs), and New-onset Chronic Diseases (NOCDs)

  An AE was development of any untoward medical occurrence in a participant or clinical study participant administered medicinal product and which did not necessarily have causal relationship with this treatment. TEAEs were AEs whose onset occurred after receiving nirsevimab through 360 days post second dose. An SAE was any AE that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly or birth defect or was an important medical event that might jeopardize the participant or may require medical treatment to prevent 1 of the outcomes listed above. AESIs were based on assessment by investigators following the administration of nirsevimab. An NOCD was a newly diagnosed medical condition of chronic, ongoing nature post administration of study drug.

  From the first dose administration (Day 1) through 360 days post 2nd dose, study Day 511

Secondary Outcomes (3)

• Serum Concentrations of Nirsevimab

  Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dose

• Number of Participants With Anti-drug Antibody (ADA) Response to Nirsevimab

  Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dose

• Serum Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibody (nAb) Levels

  Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dose

Study Arms (1)

MEDI8897

EXPERIMENTAL

Anti-RSV monoclonal antibody

Drug: Nirsevimab

Interventions

Nirsevimab DRUG

Participants in the first year of life will receive the 1st dose of nirsevimab as a single, fixed intramuscular (IM) dose of 50 mg if body weight is \<5 kg or 100 mg if body weight is ≥5 kg. A 2nd fixed IM dose of 50 mg if body weight is \<5 kg or 100 mg if body weight is ≥5 kg will be administered 5 to 6 months following the 1st dose.

Also known as: MEDI8897

MEDI8897

Eligibility Criteria

• Age: 0 Years - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent and any locally required authorization obtained from the participant's parent(s)/legally authorized representative(s) before performing any protocol-related procedures, including screening evaluations
• Japanese infants of ≤12 months of age eligible to receive palivizumab in accordance with national or local guidelines and those who must meet at least one of the following conditions at the time of informed consent.
• Immunodeficiency
• Chronic Lung Disease
• Congenital Heart Disease
• Down syndrome
• Born pre-term ≤28 wks Gestation age and aged ≤12 months, or born pre-term \>28 wks and ≤35 wks Gestation age and aged ≤6 months
• The participant's parent(s)/legally authorized representative(s) can understand and comply with the requirements of the protocol including follow-up visits as judged by the investigator.
• The participant is available to complete the follow-up period for approximately 19 months, which will be approximately 1 year after receipt of 2nd dose of nirsevimab

You may not qualify if:

• Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure (CPAP), or other mechanical respiratory or cardiac support at the time of enrollment
• A current, active RSV infection at the time of screening and investigational product administration
• Any fever (≥100.4°F \[≥38.0°C\], regardless of route) or acute illness at the time of prior to investigational product administration
• Any serious concurrent medical condition (except those resulting in an immune deficiency condition), including:
• Known renal impairment
• Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
• Any seizure disorder or evolving or unstable neurological condition
• Anticipated cardiac surgery within 5-6 months after enrollment
• Prior history of a suspected or actual acute life-threatening event
• Receipt or intended use of palivizumab in the current enrollment season
• Any known allergy or history of allergic reaction to any component of nirsevimab
• Any known allergy or history of allergic reaction to immunoglobulin products, blood products, or other foreign proteins
• Concurrent enrollment in another interventional study, or prior receipt of any investigational agent
• Anticipated survival of less than 1 year at the time of informed consent
• Any condition that, in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of study results

Sponsors & Collaborators

• AstraZeneca: lead
• IQVIA Pty Ltd: collaborator

Study Sites (9)

Research Site

Bunkyō City, 113-8519, Japan

Location

Research Site

Fuchu-shi, 183-8561, Japan

Location

Research Site

Fukuoka, 813-0017, Japan

Location

Research Site

Kitakyusyu-shi, 806-8501, Japan

Location

Research Site

Kōtoku, 135-8577, Japan

Location

Research Site

Kurume-shi, 830-0011, Japan

Location

Research Site

Nagasaki, 852-8501, Japan

Location

Research Site

Saitama-shi, 336-8522, Japan

Location

Research Site

Yokohama, 232 8555, Japan

Location

Related Links

• D5290C00009\_Redacted\_CSP
• D5290C00009\_Redacted\_SAP.
• D5290C00009\_Redacted\_CSR\_synopsis

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

nirsevimab

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

8772409479

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: No masking is used. All involved know the identity of the intervention assignment.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: September 18, 2023
• Study Start: July 27, 2023
• Primary Completion: July 24, 2025
• Study Completion: July 24, 2025
• Last Updated: April 16, 2026
• Results First Posted: April 16, 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

JP (9)