Trial · NCT00421304
A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness
NCT00421304, Not applicable, Completed, MedImmune LLC; results first posted 2021-08-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness. Trials, record NCT00421304. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00421304
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness
- NCT number
- NCT00421304
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 118 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- RSV Illness in ≤12 Months of Participants
- Interventions
- Motavizumab, Placebo
- First posted
- 2007-01-11
- Last updated
- 2021-08-27
- Results first posted
- 2021-08-27
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 0 | 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. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1 | 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. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2 | 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. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3 | 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. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4 | 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. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5 | 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. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6 | 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. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7 | 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. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30 | 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. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90 | 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. |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 0 | Day 0 | The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 0 were analyzed for this outcome. | log10 copies/mL | MEAN |
| PRIMARY | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1 | Day 1 | The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 1 were analyzed for this outcome. | log10 copies/mL | MEAN |
| PRIMARY | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2 | Day 2 | The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 2 were analyzed for this outcome. | log10 copies/mL | MEAN |
| PRIMARY | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3 | Day 3 | The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 3 were analyzed for this outcome. | log10 copies/mL | MEAN |
| PRIMARY | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4 | Day 4 | The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples, who tested positive for RSV at Day 4 were analyzed for this outcome. | log10 copies/mL | MEAN |
| PRIMARY | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5 | Day 5 | The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples, who tested positive for RSV at Day 5 were analyzed for this outcome. | log10 copies/mL | MEAN |
| PRIMARY | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6 | Day 6 | The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples, who tested positive for RSV at Day 6 were analyzed for this outcome. | log10 copies/mL | MEAN |
| PRIMARY | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7 | Day 7 | The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 7 were analyzed for this outcome. | log10 copies/mL | MEAN |
| PRIMARY | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30 | Day 30 | The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 30 were analyzed for this outcome. | log10 copies/mL | MEAN |
| PRIMARY | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90 | Day 90 | The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 90 were analyzed for this outcome. | log10 copies/mL | MEAN |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group390
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 0 | Placebo | 8.13 | Standard Deviation 0.73 | log10 copies/mL | |
| 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 0 | Motavizumab 30 mg/kg | 8.05 | Standard Deviation 1.22 | log10 copies/mL | |
| 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 0 | Motavizumab 100 mg/kg | 8.15 | Standard Deviation 0.86 | log10 copies/mL | |
| RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1 | Placebo | 7.61 | Standard Deviation 0.86 | log10 copies/mL | |
| RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1 | Motavizumab 30 mg/kg | 7.54 | Standard Deviation 1.26 | log10 copies/mL | |
| RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1 | Motavizumab 100 mg/kg | 7.40 | Standard Deviation 1.26 | log10 copies/mL | |
| RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2 | Placebo | 6.95 | Standard Deviation 1.21 | log10 copies/mL | |
| RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2 | Motavizumab 30 mg/kg | 6.68 | Standard Deviation 1.21 | log10 copies/mL | |
| RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2 | Motavizumab 100 mg/kg | 6.59 | Standard Deviation 1.35 | log10 copies/mL | |
| RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3 | Placebo | 6.12 | Standard Deviation 1.15 | log10 copies/mL |
1 to 10 of 390Source ClinicalTrials.gov
See all 390 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 40 | |
| Overall Study | STARTED | Motavizumab 30 mg/kg | 39 | |
| Overall Study | STARTED | Motavizumab 100 mg/kg | 39 | |
| Overall Study | COMPLETED | Placebo | 32 | |
| Overall Study | COMPLETED | Motavizumab 30 mg/kg | 35 | |
| Overall Study | COMPLETED | Motavizumab 100 mg/kg | 31 | |
| Overall Study | NOT COMPLETED | Placebo | 8 | |
| Overall Study | NOT COMPLETED | Motavizumab 30 mg/kg | 4 | |
| Overall Study | NOT COMPLETED | Motavizumab 100 mg/kg | 8 |
Source ClinicalTrials.gov
Adverse events123
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 37 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Motavizumab 30 mg/kg | 3 | 38 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Motavizumab 100 mg/kg | 1 | 38 | 1 |
| other | Conjunctivitis | Eye disorders | Placebo | 3 | 37 | 3 |
| other | Conjunctivitis | Eye disorders | Motavizumab 30 mg/kg | 2 | 38 | 2 |
| other | Conjunctivitis | Eye disorders | Motavizumab 100 mg/kg | 3 | 38 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 37 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Motavizumab 30 mg/kg | 2 | 38 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Motavizumab 100 mg/kg | 0 | 38 | 0 |
| other | Constipation | Gastrointestinal disorders | Placebo | 2 | 37 | 2 |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 37 |
| Total, all-cause mortality | Motavizumab 30 mg/kg | 0 | 38 |
| Total, all-cause mortality | Motavizumab 100 mg/kg | 0 | 38 |
| Total, other adverse events | Placebo | 30 | 37 |
| Total, other adverse events | Motavizumab 30 mg/kg | 22 | 38 |
| Total, other adverse events | Motavizumab 100 mg/kg | 24 | 38 |
| Total, serious adverse events | Placebo | 6 | 37 |
| Total, serious adverse events | Motavizumab 30 mg/kg | 6 | 38 |
| Total, serious adverse events | Motavizumab 100 mg/kg | 7 | 38 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24356256 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00421304
GET https://conductscience.org/api/trials/v1/NCT00421304/registered?page=2