Trial · NCT00192504
Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection
NCT00192504, Phase 1, Completed, MedImmune LLC; results first posted 2021-10-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection. Trials, record NCT00192504. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00192504
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection
- NCT number
- NCT00192504
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 31 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Respiratory Syncytial Virus Prophylaxis
- Interventions
- Motavizumab, Motavizumab, Motavizumab, Placebo
- First posted
- 2005-09-19
- Last updated
- 2021-10-08
- Results first posted
- 2021-10-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Reporting Adverse Events Through 30 Days After Dosing | From the start of treatment to 30 days after dosing | Safety and tolerability of motavizumab (MEDI-524) was measured by adverse events through 30 days after dosing |
| Primary | Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing | From the start of treatment to 30 days after dosing | Safety and tolerability of motavizumab (MEDI-524) was measured by serious adverse events through 30 days after dosing |
| Primary | The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations | From the start of treatment to 30 days after dosing | Safety and tolerability of motavizumab (MEDI-524) was measured by the occurrence of increased toxicity grade from baseline as determined by laboratory evaluations (complete blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, and urinalysis) at baseline and at each study collection time point following dosing |
| Primary | To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30 | Day 2 and Day 30 | Mean trough serum concentrations of motavizumab (MEDI-524) were collected on Day 2 and on Day 30. Serum concentrations of MEDI-524 were analysed using a qualified enzyme-linked immunosorbent assay (ELISA). |
| Secondary | To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0 | Immediately before dosing on Day 0 | The serum anti-motavizumab antibody titers were measured in subjects on Day 0 (before dosing). Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay. |
| Secondary | To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30 | Day 30 | The serum anti-motavizumab antibody titers were measured in subjects on Day 30. Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Reporting Adverse Events Through 30 Days After Dosing | From the start of treatment to 30 days after dosing | All patients who recieved study drug were included in the analysis of safety. | Participants | NUMBER |
| PRIMARY | Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing | From the start of treatment to 30 days after dosing | participants | NUMBER | |
| SECONDARY | To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0 | Immediately before dosing on Day 0 | All patients who received a full dose of study drug were included in the analysis of immunogenicity. | Participants | NUMBER |
| SECONDARY | To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30 | Day 30 | All patients who received a full dose of study drug were included in the analysis of immunogenicity. One patient in the 3 mg/kg group was not assessed for immunogenicity. | Participants | NUMBER |
| PRIMARY | The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations | From the start of treatment to 30 days after dosing | All patients who recieved study drug were included in the analysis of safety. | Participants | NUMBER |
| PRIMARY | To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30 | Day 2 and Day 30 | All patients who recieved a full dose of study drug were included in the analysis of trough serum concentrations. One patient in the 3 mg/kg group was not assessed for serum trough levels at either Day 2 or Day 30. | Micrograms per mililiter | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Reporting Adverse Events Through 30 Days After Dosing | Motavizumab (MEDI-524), 3 mg/kg | 3 | Participants | ||
| Number of Subjects Reporting Adverse Events Through 30 Days After Dosing | Motavizumab (MEDI-524), 15 mg/kg | 5 | Participants | ||
| Number of Subjects Reporting Adverse Events Through 30 Days After Dosing | Motavizumab (MEDI-524), 30 mg/kg | 3 | Participants | ||
| Number of Subjects Reporting Adverse Events Through 30 Days After Dosing | Placebo | 6 | Participants | ||
| Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing | Motavizumab (MEDI-524), 3 mg/kg | 0 | participants | ||
| Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing | Motavizumab (MEDI-524), 15 mg/kg | 0 | participants | ||
| Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing | Motavizumab (MEDI-524), 30 mg/kg | 1 | participants | ||
| Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing | Placebo | 1 | participants | ||
| To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0 | Motavizumab (MEDI-524), 3 mg/kg | 0 | Participants | ||
| To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0 | Motavizumab (MEDI-524), 15 mg/kg | 0 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Motavizumab (MEDI-524), 3 mg/kg | 5 | |
| Overall Study | STARTED | Motavizumab (MEDI-524), 15 mg/kg | 5 | |
| Overall Study | STARTED | Motavizumab (MEDI-524), 30 mg/kg | 6 | |
| Overall Study | STARTED | Placebo | 15 | |
| Overall Study | COMPLETED | Motavizumab (MEDI-524), 3 mg/kg | 4 | |
| Overall Study | COMPLETED | Motavizumab (MEDI-524), 15 mg/kg | 5 | |
| Overall Study | COMPLETED | Motavizumab (MEDI-524), 30 mg/kg | 5 | |
| Overall Study | COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | Motavizumab (MEDI-524), 3 mg/kg | 1 | |
| Overall Study | NOT COMPLETED | Motavizumab (MEDI-524), 15 mg/kg | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events148
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 | Alanine aminotransferase increased | Investigations | Motavizumab (MEDI-524), 3 mg/kg | 0 | 5 | 0 |
| other | Alanine aminotransferase increased | Investigations | Motavizumab (MEDI-524), 15 mg/kg | 1 | 5 | 1 |
| other | Alanine aminotransferase increased | Investigations | Motavizumab (MEDI-524), 30 mg/kg | 0 | 5 | 0 |
| other | Alanine aminotransferase increased | Investigations | Placebo | 0 | 15 | 0 |
| other | Allergic respiratory symptom | Respiratory, thoracic and mediastinal disorders | Motavizumab (MEDI-524), 3 mg/kg | 0 | 5 | 0 |
| other | Allergic respiratory symptom | Respiratory, thoracic and mediastinal disorders | Motavizumab (MEDI-524), 15 mg/kg | 0 | 5 | 0 |
| other | Allergic respiratory symptom | Respiratory, thoracic and mediastinal disorders | Motavizumab (MEDI-524), 30 mg/kg | 1 | 5 | 1 |
| other | Allergic respiratory symptom | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 15 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Motavizumab (MEDI-524), 3 mg/kg | 0 | 5 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Motavizumab (MEDI-524), 15 mg/kg | 0 | 5 | 0 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Motavizumab (MEDI-524), 3 mg/kg | ||
| Total, all-cause mortality | Motavizumab (MEDI-524), 15 mg/kg | ||
| Total, all-cause mortality | Motavizumab (MEDI-524), 30 mg/kg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Motavizumab (MEDI-524), 3 mg/kg | 3 | 5 |
| Total, other adverse events | Motavizumab (MEDI-524), 15 mg/kg | 5 | 5 |
| Total, other adverse events | Motavizumab (MEDI-524), 30 mg/kg | 3 | 5 |
| Total, other adverse events | Placebo | 6 | 15 |
| Total, serious adverse events | Motavizumab (MEDI-524), 3 mg/kg | 0 | 5 |
| Total, serious adverse events | Motavizumab (MEDI-524), 15 mg/kg | 0 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00192504
GET https://conductscience.org/api/trials/v1/NCT00192504/results?page=2