Trial · NCT00121108
MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States
NCT00121108, Phase 3, Completed, MedImmune LLC; results first posted 2022-01-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States. Trials, record NCT00121108. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00121108
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States
- NCT number
- NCT00121108
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,127 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Healthy
- Interventions
- Motavizumab, Placebo
- First posted
- 2005-07-21
- Last updated
- 2022-01-05
- Results first posted
- 2022-01-05
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization | From study Day 0 through study Day 150 | An RSV hospitalization is defined as either 1) a respiratory hospitalization with a positive central real-time reverse transcription polymerase chain reaction (RT-PCR) RSV test collected within 3 days of hospitalization or 2) new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From study Day 0 through study Day 150 | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. |
| Secondary | Number of Participants With RSV Outpatient Medically Attended Lower Respiratory Illness (MA LRI) | From study Day 0 through study Day 150 | The RSV outpatient MA LRI was defined as an outpatient medically attended event designated as a lower respiratory illness with a positive RT-PCR RSV test. An LRI event is one that has a medical diagnosis of bronchiolitis or pneumonia. In the absence of such a medical diagnosis, the occurrence of LRI events was determined by the principal investigator after review of the medical record and considering the presence of cough, retractions, rhonchi, wheezing, crackles, or rales, associated with symptoms (by history or clinical findings) of coryza, fever, or apnoea. |
| Secondary | Number of Participants With Medically Attended-Otitis Media (MA-OM) Events | From study Day 0 through study Day 150 | Otitis media (OM) was recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not recorded as a new OM event. |
| Secondary | Number of Participants With Frequency of MA-OM Events | From study Day 0 through study Day 150 | Otitis media was recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute TM perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not recorded as a new OM event. Number of participants with frequency of MA-OM events (either 0, 1, 2, 3, or greater than \[\>\] 3) are reported. |
| Secondary | Number of Participants With Medically Attended Wheezing Episodes | From first year through 3 years | Wheezing events were included in the analysis of medically-attended wheezing, if the medical care provider documented wheezing in the medical record or records as a discharge diagnosis any of asthma, bronchiolitis, wheezing, or reactive airway disease. A new wheezing episode was recorded as one that occurred \>2 weeks after the diagnosis of the previous episode and the medical opinion was that the wheezing does not represent a persistence of the previous episode. Number of participants with greater than or equal to (\>=) 1 MA wheezing events and \>= 3 MA wheezing events occurring from first through 3 years of age are reported. |
| Secondary | Number of Participants With Serious Early Childhood Wheezing Episodes | From first year through 3 years | Serious early childhood wheezing (SECW) was defined as: three or more medically attended wheezing events over a 12 month period occurring any time from the first through the third birthday, or a need for one or more courses of systemic steroids for a treatment of a medically attended wheezing event from the first through the third birthday, or a need for asthma-controller medication over a 12 month period for at least 3 consecutive months (\>= 90 days) or 5 cumulative months (\>= 150 days) any time from the first through the third birthday, or at least one inpatient wheezing event from the first through the third birthday. |
| Secondary | Number of Participants With Frequency of Medically Attended Wheezing Events | Study Day 0 through 3 years | Wheezing events were included in the analysis of medically-attended wheezing, if the medical care provider documented wheezing in the medical record or records as a discharge diagnosis any of asthma, bronchiolitis, wheezing, or reactive airway disease. A new wheezing episode was recorded as one that occurred \>2 weeks after the diagnosis of the previous episode and the medical opinion is that the wheezing does not represent a persistence of the previous episode. Number of participants with frequency of MA wheezing events (either 0, 1, 2, 3, 4, or greater than or equal to \[\>=\] 5) are reported. |
| Secondary | Mean Trough Serum Concentrations of Motavizumab | Day 0 (pre Dose 1) and Day 120 (Pre Dose 5) | The mean trough serum concentrations of motavizumab are reported. |
| Secondary | Number of Participants With Positive Anti-Motavizumab Antibodies After Full Dose | Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5) | The number of participants with positive serum antidrug antibodies (ADAs) to motavizumab after full dose are reported. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization | From study Day 0 through study Day 150 | The ITT population included all participants in the treatment group according to their randomized treatment group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From study Day 0 through study Day 150 | Safety population included all the participants who received any study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With RSV Outpatient Medically Attended Lower Respiratory Illness (MA LRI) | From study Day 0 through study Day 150 | The ITT population included all participants in the treatment group according to their randomized treatment group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Medically Attended-Otitis Media (MA-OM) Events | From study Day 0 through study Day 150 | The ITT population included all participants in the treatment group according to their randomized treatment group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Frequency of MA-OM Events | From study Day 0 through study Day 150 | The ITT population included all participants in the treatment group according to their randomized treatment group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Medically Attended Wheezing Episodes | From first year through 3 years | The ITT population included all participants in the treatment group according to their randomized treatment group. Here, number analyzed signified, only those participants who were analyzed from first year through 3 years. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Early Childhood Wheezing Episodes | From first year through 3 years | The ITT population included all participants in the treatment group according to their randomized treatment group. Here, number analyzed signified, only those participants who were analyzed from first year through 3 years. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Frequency of Medically Attended Wheezing Events | Study Day 0 through 3 years | The ITT population included all participants in the treatment group according to their randomized treatment group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Trough Serum Concentrations of Motavizumab | Day 0 (pre Dose 1) and Day 120 (Pre Dose 5) | Pharmacokinetics (PK) population included all participants (in seasons 1 through 3) who received at least 4 doses of motavizumab and had a post-baseline PK measurement available. Here, number analyzed signified only those participants who had adequate PK samples at the specified time points. | μg/mL | MEAN |
| SECONDARY | Number of Participants With Positive Anti-Motavizumab Antibodies After Full Dose | Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5) | Evaluable population for full dose included all participants (in season 1 through 3) who received 4 doses of motavizumab prior to ADA sample collection, and had Day 120 ADA data available. Here, number analyzed signified only those participants who had adequate ADA samples at the specified time points. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization | Placebo | 80 | Participants | ||
| Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization | Motavizumab | 21 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Placebo | TEAEs | 686 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Motavizumab | TEAEs | 1361 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Placebo | TESAEs | 148 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Motavizumab | TESAEs | 212 | Participants | |
| Number of Participants With RSV Outpatient Medically Attended Lower Respiratory Illness (MA LRI) | Placebo | 71 | Participants | ||
| Number of Participants With RSV Outpatient Medically Attended Lower Respiratory Illness (MA LRI) | Motavizumab | 41 | Participants | ||
| Number of Participants With Medically Attended-Otitis Media (MA-OM) Events | Placebo | 275 | Participants | ||
| Number of Participants With Medically Attended-Otitis Media (MA-OM) Events | Motavizumab | 532 | Participants |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 710 | |
| Overall Study | STARTED | Motavizumab | 1,417 | |
| Overall Study | COMPLETED | Placebo | 589 | |
| Overall Study | COMPLETED | Motavizumab | 1,192 | |
| Overall Study | NOT COMPLETED | Placebo | 121 | |
| Overall Study | NOT COMPLETED | Motavizumab | 225 |
Source ClinicalTrials.gov
Adverse events284
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 | Dacryostenosis congenital | Congenital, familial and genetic disorders | PLACEBO | 4 | 708 | 4 |
| other | Dacryostenosis congenital | Congenital, familial and genetic disorders | MOTAVIZUMAB | 23 | 1,414 | 24 |
| other | Cerumen impaction | Ear and labyrinth disorders | PLACEBO | 39 | 708 | 40 |
| other | Cerumen impaction | Ear and labyrinth disorders | MOTAVIZUMAB | 81 | 1,414 | 94 |
| other | Ear pain | Ear and labyrinth disorders | PLACEBO | 8 | 708 | 8 |
| other | Ear pain | Ear and labyrinth disorders | MOTAVIZUMAB | 24 | 1,414 | 24 |
| other | Conjunctivitis | Eye disorders | PLACEBO | 136 | 708 | 152 |
| other | Conjunctivitis | Eye disorders | MOTAVIZUMAB | 271 | 1,414 | 303 |
| other | Eye discharge | Eye disorders | PLACEBO | 12 | 708 | 12 |
| other | Eye discharge | Eye disorders | MOTAVIZUMAB | 21 | 1,414 | 21 |
1 to 10 of 284Source ClinicalTrials.gov
See all 284 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PLACEBO | 5 | 708 |
| Total, all-cause mortality | MOTAVIZUMAB | 8 | 1,414 |
| Total, other adverse events | PLACEBO | 682 | 708 |
| Total, other adverse events | MOTAVIZUMAB | 1,345 | 1,414 |
| Total, serious adverse events | PLACEBO | 148 | 708 |
| Total, serious adverse events | MOTAVIZUMAB | 212 | 1,414 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26511956 | 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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Motavizumab vs Placebo: Number of Participants With RSV Outpatient Medically Attended Lower Respiratory Illness (MA LRI) | Trial comparisons |
| Motavizumab vs Placebo: Number of Participants With Medically Attended-Otitis Media (MA-OM) Events | Trial comparisons |
| Motavizumab vs Placebo: Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization | Trial comparisons |
| MOTAVIZUMAB vs PLACEBO: deaths from any cause | Trial comparisons |
| MOTAVIZUMAB vs PLACEBO: 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/NCT00121108
GET https://conductscience.org/api/trials/v1/NCT00121108/results?page=2