Trial · NCT00129766
Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children
NCT00129766, Phase 3, Completed, MedImmune LLC; results first posted 2013-08-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children. Trials, record NCT00129766. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00129766
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children
- NCT number
- NCT00129766
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 6,635 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- motavizumab (MEDI-524), palivizumab
- First posted
- 2005-08-12
- Last updated
- 2013-08-28
- Results first posted
- 2013-08-28
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of RSV Hospitalization (Includes Deaths by RSV) | Days 0 - 150 | RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence). |
| Primary | Number of Participants Reporting Any Adverse Events (AEs) | Days 0 - 150 | Number of participants reporting one or more AEs |
| Primary | Number of Participants Reporting Any Related AEs | Days 0 - 150 | Number of participants reporting one or more AEs considered related to study drug by the investigator |
| Primary | Number of Participants Reporting Any Serious Adverse Events (SAEs) | Days 0 - 150 | Number of participants reporting one or more SAEs |
| Primary | Number of Participants Reporting Any Related SAEs | Days 0 - 150 | Number of participants reporting one or more SAEs considered related to study drug by the investigator |
| Primary | Number of Participants Reporting AEs by Highest Severity Grade | Days 0 - 150 | Adverse events events were graded by severity; Level 1, 2, 3, or 4 |
| Primary | Number of Participants Who Discontinued Study Drug Due to AEs | Days 0 - 150 | |
| Primary | Number of Participants Who Died | Days 0 - 150 | |
| Primary | Number of Participants Reporting Changes in Vital Signs From Baseline | Days 0 - 150 | Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs |
| Secondary | The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI) | Day 0 - 150 | LRI was defined as an event of bronchiolitis or pneumonia or the occurance of a lower tract infectious illness as determined by the PI based on medical history, signs, and symptoms. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of RSV Hospitalization (Includes Deaths by RSV) | Days 0 - 150 | The Intent-to-Treat (ITT) Population included all patients randomized into the study. | Participants | NUMBER |
| PRIMARY | Number of Participants Reporting Any Adverse Events (AEs) | Days 0 - 150 | The Safety Population included all patients who received any study drug and had any safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Participants Reporting Any Related AEs | Days 0 - 150 | The Safety Population included all patients who received any study drug and had any safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Participants Reporting Any Serious Adverse Events (SAEs) | Days 0 - 150 | The Safety Population included all patients who received any study drug and had any safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Participants Reporting Any Related SAEs | Days 0 - 150 | The Safety Population included all patients who received any study drug and had any safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Participants Reporting AEs by Highest Severity Grade | Days 0 - 150 | The Safety Population included all patients who received any study drug and had any safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Participants Who Discontinued Study Drug Due to AEs | Days 0 - 150 | The Safety Population included all patients who received any study drug and had any safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Participants Who Died | Days 0 - 150 | The Safety Population included all patients who received any study drug and had any safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Participants Reporting Changes in Vital Signs From Baseline | Days 0 - 150 | The Safety Population included all patients who received any study drug and had any safety follow-up. | participants | NUMBER |
| SECONDARY | The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI) | Day 0 - 150 | The Intent-to-Treat (ITT) Population included all patients randomized into the study. | Participant | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group71
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of RSV Hospitalization (Includes Deaths by RSV) | Palivizumab | 62 | Participants | ||
| Incidence of RSV Hospitalization (Includes Deaths by RSV) | Motavizumab | 46 | Participants | ||
| Number of Participants Reporting Any Adverse Events (AEs) | Palivizumab | 2837 | participants | ||
| Number of Participants Reporting Any Adverse Events (AEs) | Motavizumab | 2839 | participants | ||
| Number of Participants Reporting Any Related AEs | Palivizumab | 258 | participants | ||
| Number of Participants Reporting Any Related AEs | Motavizumab | 298 | participants | ||
| Number of Participants Reporting Any Serious Adverse Events (SAEs) | Palivizumab | 506 | participants | ||
| Number of Participants Reporting Any Serious Adverse Events (SAEs) | Motavizumab | 485 | participants | ||
| Number of Participants Reporting Any Related SAEs | Palivizumab | 8 | participants | ||
| Number of Participants Reporting Any Related SAEs | Motavizumab | 9 | participants |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Palivizumab | 3,306 | |
| Overall Study | STARTED | Motavizumab | 3,329 | |
| Overall Study | COMPLETED | Palivizumab | 3,246 | |
| Overall Study | COMPLETED | Motavizumab | 3,270 | |
| Overall Study | NOT COMPLETED | Palivizumab | 60 | |
| Overall Study | NOT COMPLETED | Motavizumab | 59 |
Source ClinicalTrials.gov
Adverse events688
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 | Palivizumab | 73 | 3,298 | 75 |
| other | ANAEMIA | Blood and lymphatic system disorders | Motavizumab | 66 | 3,315 | 67 |
| other | DACRYOSTENOSIS CONGENITAL | Congenital, familial and genetic disorders | Palivizumab | 33 | 3,298 | 34 |
| other | DACRYOSTENOSIS CONGENITAL | Congenital, familial and genetic disorders | Motavizumab | 35 | 3,315 | 37 |
| other | CONJUNCTIVITIS | Eye disorders | Palivizumab | 251 | 3,298 | 285 |
| other | CONJUNCTIVITIS | Eye disorders | Motavizumab | 246 | 3,315 | 271 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Palivizumab | 70 | 3,298 | 73 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Motavizumab | 54 | 3,315 | 55 |
| other | CONSTIPATION | Gastrointestinal disorders | Palivizumab | 227 | 3,298 | 262 |
| other | CONSTIPATION | Gastrointestinal disorders | Motavizumab | 234 | 3,315 | 265 |
1 to 10 of 688Source ClinicalTrials.gov
See all 688 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Palivizumab | ||
| Total, all-cause mortality | Motavizumab | ||
| Total, other adverse events | Palivizumab | 2,777 | 3,298 |
| Total, other adverse events | Motavizumab | 2,784 | 3,315 |
| Total, serious adverse events | Palivizumab | 506 | 3,298 |
| Total, serious adverse events | Motavizumab | 485 | 3,315 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20008423 | RESULT |
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 comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Palivizumab vs Motavizumab: Number of Participants Reporting Any Related AEs | Trial comparisons |
| Palivizumab vs Motavizumab: Number of Participants Reporting Any Related SAEs | Trial comparisons |
| Palivizumab vs Motavizumab: Number of Participants Reporting Any Adverse Events (AEs) | Trial comparisons |
| Palivizumab vs Motavizumab: Number of Participants Who Discontinued Study Drug Due to AEs | Trial comparisons |
| Palivizumab vs Motavizumab: Number of Participants Reporting Any Serious Adverse Events (SAEs) | Trial comparisons |
| Palivizumab vs Motavizumab: Number of Participants Who Died | Trial comparisons |
| Palivizumab vs Motavizumab: Incidence of RSV Hospitalization (Includes Deaths by RSV) | Trial comparisons |
| Palivizumab vs Motavizumab: The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups | Trial comparisons |
| Palivizumab vs Motavizumab: serious adverse events | Trial comparisons |
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/NCT00129766
GET https://conductscience.org/api/trials/v1/NCT00129766/results?page=2