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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
No Placebo-Only Group

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)

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: NirsevimabExperimental Treatment1 Intervention
1st RSV season: 50mg nirsevimab 1. st RSV season: 100mg nirsevimab 2. 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
4,395 Previous Clinical Trials
289,121,517 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
116 Previous Clinical Trials
174,470 Total Patients Enrolled
~19 spots leftby Nov 2025
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