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The study was terminated early due to an inability to enroll the planned number of participants
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This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg intramuscular (IM) dose of motavizumab on viral load and motavizumab levels in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Using 1:1 randomization, 30 mg/kg motavizumab or placebo will be administered as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study has been confirmed.
This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg IM dose of motavizumab on viral load in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Participants were randomly assigned in a 1:1 ratio to 30 mg/kg motavizumab or placebo as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study had been confirmed. Randomization was stratified by age (<6 months and greater than or equal to 6 to less than or equal to 12 months of age) and by site. Enrollment of an initial 100 children (50 per treatment group) will take place at multiple sites beginning in the 2006-2007 RSV season. The study was terminated early due to inability to enroll the planned number of participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motavizumab | Experimental | Participants will receive a single IM dose of 30 mg/kg of motavizumab on Day 0 of the study. |
|
| Placebo | Placebo Comparator | Participants will receive a single IM dose of placebo matched to motavizumab on Day 0 of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motavizumab | Biological | A single IM dose of 30 mg/kg will be administered on Day 0 of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by Reverse Transcriptase-polymerase Chain Reaction (RT-PCR) at Day 0 | The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates. | Day 0 |
| RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 2 | The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates. | Day 2 |
| RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 30 | The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates. | Day 30 |
| RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 90 | The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates. | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Have Progression of RSV Illness That Requires Subsequent Hospitalization | The percentage of participants who have progression of RSV illness that requires subsequent hospitalization is reported. RSV illness symptomps included fever, coryza, cough, and parental opinion of return to normal health and activity. | From Randomiation (Day 0) Up to Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Pamela Griffin, M.D. | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tucson | Arizona | United States | |||
| Research Site |
A total of 12 participants were randomized in the study.
The study was conducted from 20Mar2007 to 31May2008 in the United States of America.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study. |
| FG001 | Motavizumab 30 mg | Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Other | A single IM dose of placebo matched to motavizumab will be administered on Day 0 of the study. |
|
| Respiratory Assessment Change Score (RACS) Derived From Baseline | The RACS assesses changes in wheezing and retractions as measured by the respiratory distress assessment instrument (RDAI) score and changes in respiratory rate. A RDAI score is a measure of the degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. Change in respiratory rate of less than or equal to (<=) 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in respiratory rate. The RACS is calculated as arithmetic sum of RDAI score change and of the standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in RACS represents improvement, whereas an increase signifies deterioration. | Baseline (Day 0); and Days 2, 7, and 30 |
| Change From Baseline in Oxygen Saturation Level | Change from baseline in oxygen saturation level is reported. | Baseline (Day 0), Days 2, 7, and 30 |
| Change in RACS of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization | The RACS assesses changes in wheezing and retractions as measured by the RDAI score and changes in respiratory rate. A RDAI score is a measure of the degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. A change in respiratory rate of <= 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate. The RACS is calculated as the arithmetic sum of the RDAI score change and of the standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in the RACS represents improvement, whereas an increase signifies deterioration. | Baseline (Day 0) to Day 30 |
| Oxygen Saturation Levels in RSV-infected Outpatient Participants Who Subsequently Required Hospitalization | Baseline (Day 0) to Day 30 |
| Heart Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization | Baseline (Day 0) to Day 30 |
| Respiratory Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization | Baseline (Day 0) to Day 30 |
| Number of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical Ventilation | Number of participants who required hospitalization, ICU stay, supplemental oxygen, and mechanical ventilation is reported. | Baseline (Day 0) to Day 90 |
| Duration of Hospitalization, ICU Stay, Supplemental Oxygen Used, and Mechanical Ventilation Required | Baseline (Day 0) to Day 90 |
| Number of Participants Who Progresses From Upper Respiratory Tract Infection to Lower Respiratory Tract Infection (LRI) | A 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 will be determined by the principal investigator after review of the medical record and based on the presence of retractions or lower respiratory tract rhonchi, wheezing, crackles, or rales in children with a positive RSV test. | Baseline (Day 0) to Day 30 |
| Number of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory Medications | Number of LRI infected participants who required hospitalization, ICU stay, supplemental oxygen, mechanical ventilation, and respiratory medications are reported. | Baseline (Day 0) to Day 30 |
| RACS in Participants With LRI | The RACS assesses changes in wheezing and retractions as measured by RDAI score and changes in respiratory rate. A RDAI score is a measure of degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. A change in respiratory rate of <= 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate. The RACS is calculated as the arithmetic sum of the RDAI score change and of the standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in the RACS represents improvement, whereas an increase signifies deterioration. RACS in participants with LRI is reported. | From Baseline (Day 0) to Days 2, 7, and 30 |
| Motavizumab Concentration in Upper Respiratory Tract | Motavizumab concentration in upper respiratory tract (nasal wash aspirates) is reported. | Days 0 (pre-dose), 2, and 30 |
| Serum Concentration of Motavizumab | Serum concentration of motavizumab is reported. | Days 2, 30, and 90 |
| Numbers of Participants With Positive Anti-Motavizumab Antibodies | The number of participants with positive serum antibodies to motavizumab are reported. | Days 0 (pre-dose) and 90 |
| Serum Cytokine Levels | Serum Cytokine Levels are reported. | Days 0 (pre-dose), 30, and 90 |
| Nasal Wash Cytokine Levels | Nasal wash cytokine levels are reported. | Days 0 (pre-dose), 2, 30, and 90 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. 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. | From the administration of study drug (Day 0) through Day 90 |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Research Site | Jonesboro | Arkansas | United States |
| Research Site | Little Rock | Arkansas | 72202 | United States |
| Research Site | Little Rock | Arkansas | United States |
| Research Site | Orange | California | 92868 | United States |
| Research Site | San Diego | California | 92103 | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Tampa | Florida | 33606 | United States |
| Research Site | Atlanta | Georgia | 30342 | United States |
| Research Site | Augusta | Georgia | 30912 | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Boston | Massachusetts | 02111 | United States |
| Research Site | Detroit | Michigan | 48201 | United States |
| Research Site | Las Vegas | Nevada | 89107 | United States |
| Research Site | Paterson | New Jersey | 07503 | United States |
| Research Site | Brooklyn | New York | 11203-2098 | United States |
| Research Site | Buffalo | New York | 14222-2099 | United States |
| Research Site | The Bronx | New York | United States |
| Research Site | Youngstown | Ohio | 44051 | United States |
| Research Site | Oklahoma City | Oklahoma | 73104 | United States |
| Research Site | Nashville | Tennessee | 37232-2581 | United States |
| Research Site | Dallas | Texas | 75230 | United States |
| Research Site | Dallas | Texas | 75390 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Richmond | Virginia | 23298 | United States |
| West Virginia University Pediactric Center | Charleston | West Virginia | 25302 | United States |
| Research Site | Charleston | West Virginia | 72205 | United States |
| Research Site | Huntington | West Virginia | 25701-3655 | United States |
| Research Site | Morgantown | West Virginia | 26506 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Intent-to-treat (ITT) population included all participants who were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study. |
| BG001 | Motavizumab 30 mg | Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by Reverse Transcriptase-polymerase Chain Reaction (RT-PCR) at Day 0 | The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates. | Intent-to-treat population included all participants who were randomized in the study. Participants who were RSV-positive at Day 0 were analyzed for this outcome. | Posted | Mean | Standard Deviation | log10 copies/mL | Day 0 |
|
|
| ||||||||||||||||||||||||||||
| Primary | RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 2 | The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates. | Intent-to-treat population included all participants who were randomized in the study. Participants who were RSV-positive at Day 2 were analyzed for this outcome. | Posted | Mean | Standard Deviation | log10 copies/mL | Day 2 |
|
| |||||||||||||||||||||||||||||
| Primary | RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 30 | The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates. | Intent-to-treat population included all participants who were randomized in the study. Participants who were RSV-positive at Day 30 were analyzed for this outcome. | Posted | Mean | Standard Deviation | log10 copies/mL | Day 30 |
|
| |||||||||||||||||||||||||||||
| Primary | RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 90 | The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates. | Intent-to-treat population included all participants who were randomized in the study. Participants who were RSV-positive at Day 90 were analyzed for this outcome. | Posted | Mean | Standard Deviation | log10 copies/mL | Day 90 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Have Progression of RSV Illness That Requires Subsequent Hospitalization | The percentage of participants who have progression of RSV illness that requires subsequent hospitalization is reported. RSV illness symptomps included fever, coryza, cough, and parental opinion of return to normal health and activity. | Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. | Posted | Number | Percentage of participants | From Randomiation (Day 0) Up to Day 30 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Respiratory Assessment Change Score (RACS) Derived From Baseline | The RACS assesses changes in wheezing and retractions as measured by the respiratory distress assessment instrument (RDAI) score and changes in respiratory rate. A RDAI score is a measure of the degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. Change in respiratory rate of less than or equal to (<=) 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in respiratory rate. The RACS is calculated as arithmetic sum of RDAI score change and of the standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in RACS represents improvement, whereas an increase signifies deterioration. | Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. | Posted | Mean | Standard Deviation | Units on a score | Baseline (Day 0); and Days 2, 7, and 30 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Oxygen Saturation Level | Change from baseline in oxygen saturation level is reported. | Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. | Posted | Mean | Standard Deviation | Percentage of oxygen saturation | Baseline (Day 0), Days 2, 7, and 30 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in RACS of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization | The RACS assesses changes in wheezing and retractions as measured by the RDAI score and changes in respiratory rate. A RDAI score is a measure of the degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. A change in respiratory rate of <= 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate. The RACS is calculated as the arithmetic sum of the RDAI score change and of the standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in the RACS represents improvement, whereas an increase signifies deterioration. | Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Data were not collected as no participants required hospitalization. | Posted | Baseline (Day 0) to Day 30 |
| |||||||||||||||||||||||||||||||||
| Secondary | Oxygen Saturation Levels in RSV-infected Outpatient Participants Who Subsequently Required Hospitalization | Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Data were not collected as no participants required hospitalization. | Posted | Baseline (Day 0) to Day 30 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Heart Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization | Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Data were not collected as no participants required hospitalization. | Posted | Baseline (Day 0) to Day 30 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Respiratory Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization | Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Data were not collected as no participants required hospitalization. | Posted | Baseline (Day 0) to Day 30 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical Ventilation | Number of participants who required hospitalization, ICU stay, supplemental oxygen, and mechanical ventilation is reported. | Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. | Posted | Count of Participants | Participants | Baseline (Day 0) to Day 90 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Hospitalization, ICU Stay, Supplemental Oxygen Used, and Mechanical Ventilation Required | Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Data were not collected as no participants were hospitalized or received intensive care or supplemental oxygen, or mechanical ventilation. | Posted | Baseline (Day 0) to Day 90 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Progresses From Upper Respiratory Tract Infection to Lower Respiratory Tract Infection (LRI) | A 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 will be determined by the principal investigator after review of the medical record and based on the presence of retractions or lower respiratory tract rhonchi, wheezing, crackles, or rales in children with a positive RSV test. | Safety population included all participants who had received any study drug and had any follow-up. | Posted | Count of Participants | Participants | Baseline (Day 0) to Day 30 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory Medications | Number of LRI infected participants who required hospitalization, ICU stay, supplemental oxygen, mechanical ventilation, and respiratory medications are reported. | Safety population included all participants who had received any study drug and had any follow-up. Participants with LRI were analyzed for this outcome. | Posted | Count of Participants | Participants | Baseline (Day 0) to Day 30 |
|
| ||||||||||||||||||||||||||||||
| Secondary | RACS in Participants With LRI | The RACS assesses changes in wheezing and retractions as measured by RDAI score and changes in respiratory rate. A RDAI score is a measure of degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. A change in respiratory rate of <= 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate. The RACS is calculated as the arithmetic sum of the RDAI score change and of the standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in the RACS represents improvement, whereas an increase signifies deterioration. RACS in participants with LRI is reported. | Safety population included all participants who had received any study drug and had any follow-up. Participants with LRI were analyzed for this outcome. | Posted | Mean | Standard Deviation | Units on a score | From Baseline (Day 0) to Days 2, 7, and 30 |
| ||||||||||||||||||||||||||||||
| Secondary | Motavizumab Concentration in Upper Respiratory Tract | Motavizumab concentration in upper respiratory tract (nasal wash aspirates) is reported. | Evaluable population for pharmacokinetic (PK) included all participants who have received a full dose of study drug. | Posted | Mean | Standard Deviation | ng/mL | Days 0 (pre-dose), 2, and 30 |
|
| |||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Motavizumab | Serum concentration of motavizumab is reported. | Evaluable population for PK included all participants who have received a full dose of study drug. | Posted | Mean | Standard Deviation | mcg/mL | Days 2, 30, and 90 |
|
| |||||||||||||||||||||||||||||
| Secondary | Numbers of Participants With Positive Anti-Motavizumab Antibodies | The number of participants with positive serum antibodies to motavizumab are reported. | Evaluable population for ADA included all participants who have received a full dose of study drug. Participants with adequate ADA samples were analysed for this outcome measure. | Posted | Count of Participants | Participants | Days 0 (pre-dose) and 90 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Serum Cytokine Levels | Serum Cytokine Levels are reported. | Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Participants with adequate cytokine levels at specified time points were analyzed for this outcome. | Posted | Mean | Standard Deviation | Picograms per millilitre (pg/mL) | Days 0 (pre-dose), 30, and 90 |
|
| |||||||||||||||||||||||||||||
| Secondary | Nasal Wash Cytokine Levels | Nasal wash cytokine levels are reported. | Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Participants with adequate nasal wash cytokine levels at specified time points were analyzed for this outcome. | Posted | Mean | Standard Deviation | pg/mL | Days 0 (pre-dose), 2, 30, and 90 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. 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. | Safety population included all participants who had received any study drug and had any follow-up. | Posted | Count of Participants | Participants | From the administration of study drug (Day 0) through Day 90 |
|
From the administration of study drug (Day 0) through Day 90
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study. | 0 | 5 | 2 | 5 | 5 | 5 |
| EG001 | Motavizumab 30 mg | Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study. | 0 | 7 | 0 | 7 | 6 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Lip blister | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Viral skin infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Feeding disorder of infancy or early childhood | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
On 21Feb2008, the study was terminated earlier than planned completion time due to an inability to enroll planned number of participants. Due to low enrollment, the data for outcome measure of "Duration of symptoms of RSV illness" was not collected.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca Clinical study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
| ID | Term |
|---|---|
| C506968 | motavizumab |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Day 0 |
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| Day 2 |
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| Day 30 |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Day 2 |
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| Day 30 |
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| Day 90 |
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| Units | Counts |
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| Participants |
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