Respiratory Syncytial Virus InfectionsPhase 3JUBILUSNCT06042049
A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab
A Phase 3 study testing Nirsevimab in people with Respiratory Syncytial Virus Infections, run by AstraZeneca at 9 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years to 1 year
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- Nirsevimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 9 sitesJapan
- Study dates
- 27 Jul 2023to 24 Jul 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Research Site
Bunkyō City, 113-8519
Research Site
Fuchu-shi, 183-8561
Research Site
Fukuoka, 813-0017
Research Site
Kitakyusyu-shi, 806-8501
Research Site
Kōtoku, 135-8577
Research Site
Kurume-shi, 830-0011
Research Site
Nagasaki, 852-8501
Research Site
Saitama-shi, 336-8522
Research Site
Yokohama, 232 8555
About this study
Official 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
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
- Being tested
- Nirsevimab
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NirsevimabDrug
Also called MEDI8897
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.
| Study group | Role | What they receive |
|---|---|---|
| MEDI8897 | Experimental | Anti-RSV monoclonal antibody Receives: Drug: Nirsevimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the first dose administration (Day 1) through 360 days post 2nd dose, study Day 511
Secondary outcomes (3)
Serum Concentrations of Nirsevimab
Serum samples were collected at specified timepoints to evaluate concentrations of nirsevimab at selected time points.
Measured: 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
Blood samples were analyzed for the presence of ADAs for nirsevimab using an appropriately validated bioanalytical method.
Measured: 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
Blood samples were collected for the determination anti-RSV nAb in serum using an appropriately validated bioanalytical method.
Measured: Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start27 Jul 2023
- Primary completion24 Jul 2025
- Study completion24 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042049
- Sponsor's protocol ID
- D5290C00009
- Other IDs
- 2025-000021-13, 2025
- Acronym
- JUBILUS
- Status last verified
- Mar 2026
- First submitted
- 13 Jul 2023
- Last updated
- 16 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.