Adults 0 Months to 12 Months, any sex, with RSV Illness in ≤12 Months of Participants. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 0Primary· Day 0
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children less than or equal to (\<=12) months of age who are hospitalized with lower respiratory tract illness.
Group
Value
95% CI
Placebo
8.13
± 0.73
Motavizumab 30 mg/kg
8.05
± 1.22
Motavizumab 100 mg/kg
8.15
± 0.86
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1Primary· Day 1
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Group
Value
95% CI
Placebo
7.61
± 0.86
Motavizumab 30 mg/kg
7.54
± 1.26
Motavizumab 100 mg/kg
7.40
± 1.26
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2Primary· Day 2
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Group
Value
95% CI
Placebo
6.95
± 1.21
Motavizumab 30 mg/kg
6.68
± 1.21
Motavizumab 100 mg/kg
6.59
± 1.35
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3Primary· Day 3
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Group
Value
95% CI
Placebo
6.12
± 1.15
Motavizumab 30 mg/kg
6.11
± 1.26
Motavizumab 100 mg/kg
5.95
± 1.46
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4Primary· Day 4
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Group
Value
95% CI
Placebo
6.00
± 0.58
Motavizumab 30 mg/kg
5.76
± 0.82
Motavizumab 100 mg/kg
5.41
± 1.44
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5Primary· Day 5
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Group
Value
95% CI
Placebo
5.52
± 0.68
Motavizumab 30 mg/kg
5.26
± 1.20
Motavizumab 100 mg/kg
5.31
± 1.94
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6Primary· Day 6
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Group
Value
95% CI
Placebo
5.63
± 0.91
Motavizumab 30 mg/kg
5.25
± 1.58
Motavizumab 100 mg/kg
5.60
± 2.08
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7Primary· Day 7
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Group
Value
95% CI
Placebo
4.86
± 1.45
Motavizumab 30 mg/kg
4.73
± 1.27
Motavizumab 100 mg/kg
4.52
± 1.70
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30Primary· Day 30
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Group
Value
95% CI
Placebo
3.03
± 1.11
Motavizumab 30 mg/kg
3.05
± 1.33
Motavizumab 100 mg/kg
2.96
± 1.08
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90Primary· Day 90
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Group
Value
95% CI
Placebo
2.66
± 0.70
Motavizumab 30 mg/kg
2.55
± 0.29
Motavizumab 100 mg/kg
2.50
± 0.00
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180Primary· Day 180
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Group
Value
95% CI
Placebo
2.68
± 0.95
Motavizumab 30 mg/kg
2.52
± 0.09
Motavizumab 100 mg/kg
2.50
± 0.00
Motavizumab Concentration in Nasal Wash Aspirates at Day 0Primary· Day 0
Motavizumab concentration in nasal wash aspirates is reported.
Group
Value
95% CI
Motavizumab 30 mg/kg
0.93
± 5.72
Motavizumab 100 mg/kg
0.00
± 0.00
Adverse events — posted to ClinicalTrials.gov
Time frame: From the start of study drug (Day 0) through Day 90.
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of this study is to describe the effect of a single dose of medication compared to placebo in the upper respiratory tract in previously healthy children less than or equal to 12 months of age who are hospitalized with lower respiratory tract illness.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT00435227 — A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV)
· Phase 2
· terminated
NCT00121108 — MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infan
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MedImmune LLC
Last refreshed: 27 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00421304.