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Monoclonal Antibodies

Nirsevimab for Respiratory Syncytial Virus (MUSIC Trial)

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and on days 8 (for japanese participants), 31, 151 and 361
Awards & highlights

MUSIC Trial Summary

This trial is testing a new drug to see if it is safe and effective in young children who have a weakened immune system. About 100 children will be enrolled and followed for 1 year.

Eligible Conditions
  • Respiratory Syncytial Virus (RSV)

MUSIC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and on days 8 (for japanese participants), 31, 151 and 361
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and on days 8 (for japanese participants), 31, 151 and 361 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious AEs (TESAEs), AEs of Special Interest (AESIs), and New Onset Chronic Disease (NOCDs)
Secondary outcome measures
Number of Participants With Anti-Drug Antibody (ADA) Response to Nirsevimab
Number of Participants With Medically Attended (MA) RSV LRTI (Inpatient and Outpatient) and Hospitalizations
Serum Concentrations of Nirsevimab

Side effects data

From 2023 Phase 2 trial • 100 Patients • NCT04484935
35%
Upper respiratory tract infection
25%
Pyrexia
25%
Vomiting
23%
COVID-19
19%
Diarrhoea
15%
Dermatitis diaper
13%
Rhinorrhoea
12%
Nasopharyngitis
12%
Otitis media
12%
Gastroenteritis
10%
Rhinitis
8%
Cough
8%
Gastroenteritis viral
8%
Gastrointestinal viral infection
8%
Pneumonia
8%
Otitis media acute
6%
Anaemia
6%
Nasal congestion
6%
Lower respiratory tract infection
6%
Hand-foot-and-mouth disease
6%
Viral upper respiratory tract infection
6%
Ear infection
6%
Neutropenia
6%
Abdominal pain
4%
Febrile neutropenia
4%
Conjunctivitis
4%
Constipation
4%
Bacteraemia
4%
Nephrotic syndrome
4%
Klebsiella sepsis
4%
Thrombocytopenia
2%
Dry skin
2%
Rash
2%
Device related sepsis
2%
Malnutrition
2%
Giardiasis
2%
Volvulus
2%
Klebsiella bacteraemia
2%
Urethritis
2%
Iatrogenic injury
2%
Tonsillar hypertrophy
2%
Complication associated with device
2%
Hepatic cytolysis
2%
Transplant rejection
2%
Graft versus host disease
2%
Escherichia pyelonephritis
2%
Gastroenteritis Escherichia coli
2%
Lower respiratory tract infection viral
2%
Staphylococcal bacteraemia
2%
Seizure
2%
Adenoidal hypertrophy
2%
Feeding intolerance
2%
Oral herpes
2%
Postoperative wound infection
2%
Intracranial pressure increased
2%
Pneumonia viral
2%
Sickle cell disease
2%
Serratia sepsis
2%
Gastrostomy failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nirsevimab 200 mg
Nirsevimab 50 mg/100 mg

MUSIC Trial Design

1Treatment groups
Experimental Treatment
Group I: NirsevimabExperimental Treatment1 Intervention
1st RSV season: 50mg nirsevimab st RSV season: 100mg nirsevimab nd RSV season: 200mg nirsevimab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nirsevimab
2020
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,606,881 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
107 Previous Clinical Trials
169,968 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible for individuals aged sixty and above to participate in this research?

"This clinical research is seeking participants between infancy and two years of age."

Answered by AI

What are the primary goals of this research endeavor?

"This research project, which is expected to last 360 days past the dose administration period, aims to observe Treatment emergent serious adverse events (TESAEs). Additional objectives include measuring Area under the concentration-time curve [AUC], Apparent clearance, and terminal-phase half-life [t1/2] as well as Maximum observed concentration [Cmax]. All of these parameters help evaluate nirsevimab's PK."

Answered by AI

Has a research initiative of this magnitude ever been undertaken before?

"Nirsevimab, a drug developed by MedImmune LLC and studied in 3013 patients since 2019, is currently the subject of 3 active trials spanning 34 countries and 103 cities. Subsequent to completing Phase 3 clinical approval 4 years ago, numerous other studies have been concluded."

Answered by AI

Has the FDA sanctioned Nirsevimab for medicinal applications?

"Nirsevimab's safety was estimated at a 2 on our scale due to the lack of efficacy-related data surrounding this Phase 2 trial."

Answered by AI

What is the aggregate size of this group participating in the research?

"At the present moment, this medical trial is not open to potential participants. Initially posted on August 19th 2020, it was most recently updated on November 10th 2022. For those looking for other clinical trials, there are currently 33 studies recruiting patients with infections and 3 separate nirsevimab trials searching for enrollments."

Answered by AI

Are there any existing records of Nirsevimab being tested in a research setting?

"At present, Nirsevimab is being studied in three clinical trials; two of which are currently at Phase 3. Despite the primary research sites being located in Gent and Virginia, there exist 366 other locations to participate in the study."

Answered by AI

Are there ample healthcare facilities conducting this research endeavor in the United States?

"Currently, this trial is running out of 9 distinct medical facilities, including those in Syracuse, Chicago and Fort Worth. For individuals who want to take part but don't wish to incur a lot of travel costs or time commitments, it might be best to select the closest site."

Answered by AI

Is there an opportunity for me to participate in this trial?

"This study is recruiting 100 infants and toddlers aged 0-2, affected by Respiratory Syncytial Virus. To qualify for the clinical trial, these individuals must meet certain criteria including being diagnosed with a combined immunodeficiency or Human Immunodeficiency Virus infection, receiving immunosuppressive chemotherapy, systemic high-dose corticosteroid therapy (over 0.5mg/kg every other day), or another form of immunosuppressive treatment; as well as having their parent(s)/legal representative(s) agree to the consent process and follow up visits which will span one year after they receive nirse"

Answered by AI

Are there vacancies in this clinical trial that individuals may participate in?

"The trial is no longer accepting applicants. Originally posted on August 19th 2020 and last updated November 10 2022, other prospective studies that involve infections such as respiratory syncytial virus (RSV) or Nirsevimab have 33 locations actively recruiting participants."

Answered by AI
~21 spots leftby Apr 2025