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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06042049




Registration number
NCT06042049
Ethics application status
Date submitted
13/07/2023
Date registered
18/09/2023

Titles & IDs
Public title
A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab
Scientific title
A Phase III Single-Arm Open-Label Study to Evaluate the Safety PK ADA and Anti RSV nAb Following Administration of 2 Doses of Nirsevimab Given 5 to 6 Months Apart in Infants With CHD, CLD, Immunocompromise, Down Syndrome, or Born Pre-Term in Japan
Secondary ID [1] 0 0
D5290C00009
Universal Trial Number (UTN)
Trial acronym
JUBILUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nirsevimab

Experimental: MEDI8897 - Anti-RSV monoclonal antibody


Treatment: Drugs: Nirsevimab
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of all TEAEs, TESAEs, AESIs, and NOCDs
Timepoint [1] 0 0
360 days after the 2nd or last dose administered in the study
Primary outcome [2] 0 0
Study discontinuations prior to Day 151 post 2nd dose.
Timepoint [2] 0 0
360 days after the 2nd or last dose administered in the study
Secondary outcome [1] 0 0
Pharmacokinetics (PK) - Nirsevimab serum concentrations
Timepoint [1] 0 0
360 days after the 2nd or last dose administered in the study
Secondary outcome [2] 0 0
ADA - Occurrence of ADA to nirsevimab in serum
Timepoint [2] 0 0
360 days after the 2nd or last dose administered in the study
Secondary outcome [3] 0 0
Anti-RSV neutralizing Ab - Anti-RSV neutralizing Ab levels (IU/mL) in serum
Timepoint [3] 0 0
360 days after the 2nd or last dose administered in the study

Eligibility
Key inclusion criteria
1. 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
2. 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.

1. Immunodeficiency
2. Chronic Lung Disease
3. Congenital Heart Disease
4. Down syndrome
5. 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
3. 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.
4. 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
Minimum age
0 Years
Maximum age
1 Year
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure (CPAP), or other mechanical respiratory or cardiac support at the time of enrollment
2. A current, active RSV infection at the time of screening and investigational product administration
3. Any fever (=100.4°F [=38.0°C], regardless of route) or acute illness at the time of prior to investigational product administration
4. Any serious concurrent medical condition (except those resulting in an immune deficiency condition), including:

1. Known renal impairment
2. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
3. Any seizure disorder or evolving or unstable neurological condition
5. Anticipated cardiac surgery within 5-6 months after enrollment
6. Prior history of a suspected or actual acute life-threatening event
7. Receipt or intended use of palivizumab in the current enrollment season
8. Any known allergy or history of allergic reaction to any component of nirsevimab
9. Any known allergy or history of allergic reaction to immunoglobulin products, blood products, or other foreign proteins
10. Concurrent enrollment in another interventional study, or prior receipt of any investigational agent
11. Anticipated survival of less than 1 year at the time of informed consent
12. Any condition that, in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of study results
13. 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/04/2025
Actual
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Japan
State/province [1] 0 0
Bunkyo-ku
Country [2] 0 0
Japan
State/province [2] 0 0
Fuchu-shi
Country [3] 0 0
Japan
State/province [3] 0 0
Fukuoka-shi
Country [4] 0 0
Japan
State/province [4] 0 0
Kitakyusyu-shi
Country [5] 0 0
Japan
State/province [5] 0 0
Koto-ku
Country [6] 0 0
Japan
State/province [6] 0 0
Kurume-shi
Country [7] 0 0
Japan
State/province [7] 0 0
Nagasaki-shi
Country [8] 0 0
Japan
State/province [8] 0 0
Saitama-shi
Country [9] 0 0
Japan
State/province [9] 0 0
Yokohama-shi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Iqvia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06042049