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MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American Infants in the Southwestern United States during their first RSV season.
MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American infants during their first RSV season.
Participants were randomized in a 2:1 ratio to receive either 15 mg/kg motavizumab or placebo by intramuscular (IM) injection every 30 days during the RSV season for a maximum of 5 injections.
During their first RSV season, participants were evaluated monthly just prior to each injection of study drug for adverse events (AEs) (including medically attended otitis media), with a final post-dosing follow up evaluation at Study Day 150. During Seasons 1, 2, and 3, blood was to be collected prior to the first and last dose of study drug for serum chemistry evaluations, motavizumab serum concentrations, and anti-motavizumab antibodies. Efficacy and safety outcomes were examined through Study Day 150 and wheezing outcomes were evaluated from the time of randomization until the third birthday.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive IM dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the the RSV season. |
|
| Motavizumab | Active Comparator | Participants will receive IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motavizumab | Biological | Intramuscular dose of motavizumab 15 mg/kg will be administered every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization | 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. | From study Day 0 through study Day 150 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MedImmune, LLC MedImmune, LLC | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chinle | Arizona | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26511956 | Derived | O'Brien KL, Chandran A, Weatherholtz R, Jafri HS, Griffin MP, Bellamy T, Millar EV, Jensen KM, Harris BS, Reid R, Moulton LH, Losonsky GA, Karron RA, Santosham M; Respiratory Syncytial Virus (RSV) Prevention study group. Efficacy of motavizumab for the prevention of respiratory syncytial virus disease in healthy Native American infants: a phase 3 randomised double-blind placebo-controlled trial. Lancet Infect Dis. 2015 Dec;15(12):1398-408. doi: 10.1016/S1473-3099(15)00247-9. Epub 2015 Nov 4. |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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The study was conducted from 15 Nov 2004 to 27 Dec 2010 in the United States of America.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season. |
| FG001 | Motavizumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Other | Intramuscular dose of placebo matched to motavizumab will be administered every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the the RSV season. |
|
| From study Day 0 through study Day 150 |
| Number of Participants With RSV Outpatient Medically Attended Lower Respiratory Illness (MA LRI) | 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. | From study Day 0 through study Day 150 |
| Number of Participants With Medically Attended-Otitis Media (MA-OM) Events | 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. | From study Day 0 through study Day 150 |
| Number of Participants With Frequency of MA-OM Events | 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. | From study Day 0 through study Day 150 |
| Number of Participants With Medically Attended Wheezing Episodes | 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. | From first year through 3 years |
| Number of Participants With Serious Early Childhood Wheezing Episodes | 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. | From first year through 3 years |
| Number of Participants With Frequency of Medically Attended Wheezing Events | 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. | Study Day 0 through 3 years |
| Mean Trough Serum Concentrations of Motavizumab | The mean trough serum concentrations of motavizumab are reported. | Day 0 (pre Dose 1) and Day 120 (Pre Dose 5) |
| Number of Participants With Positive Anti-Motavizumab Antibodies After Full Dose | The number of participants with positive serum antidrug antibodies (ADAs) to motavizumab after full dose are reported. | Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5) |
| Number of Participants With Positive Anti-Motavizumab Antibodies After Any Dose | The number of participants with positive serum ADA to motavizumab after any dose are reported. | Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5) |
| Cibecue |
| Arizona |
| United States |
| Research Site | Fort Definace | Arizona | United States |
| Research Site | San Carlos | Arizona | United States |
| Research Site | Tuba City | Arizona | United States |
| Research Site | Whiteriver | Arizona | United States |
| Research Site | Winslow | Arizona | United States |
| Research Site | Baltimore | Maryland | 21205 | United States |
| Research Site | Bloomfield | New Mexico | United States |
| Research Site | Crownpoint | New Mexico | United States |
| Research Site | Gallup | New Mexico | United States |
| Research Site | Shiprock | New Mexico | United States |
Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season. |
| COMPLETED |
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| NOT COMPLETED |
|
|
The Intent to treat (ITT) population included all participants in the treatment group according to their randomized treatment group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season. |
| BG001 | Motavizumab | Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season. |
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization | 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. | The ITT population included all participants in the treatment group according to their randomized treatment group. | Posted | Count of Participants | Participants | From study Day 0 through study Day 150 |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. 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. | Safety population included all the participants who received any study drug. | Posted | Count of Participants | Participants | From study Day 0 through study Day 150 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With RSV Outpatient Medically Attended Lower Respiratory Illness (MA LRI) | 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. | The ITT population included all participants in the treatment group according to their randomized treatment group. | Posted | Count of Participants | Participants | From study Day 0 through study Day 150 |
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| Secondary | Number of Participants With Medically Attended-Otitis Media (MA-OM) Events | 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. | The ITT population included all participants in the treatment group according to their randomized treatment group. | Posted | Count of Participants | Participants | From study Day 0 through study Day 150 |
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| Secondary | Number of Participants With Frequency of MA-OM Events | 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. | The ITT population included all participants in the treatment group according to their randomized treatment group. | Posted | Count of Participants | Participants | From study Day 0 through study Day 150 |
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| Secondary | Number of Participants With Medically Attended Wheezing Episodes | 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. | 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. | Posted | Count of Participants | Participants | From first year through 3 years |
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| Secondary | Number of Participants With Serious Early Childhood Wheezing Episodes | 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. | 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. | Posted | Count of Participants | Participants | From first year through 3 years |
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| Secondary | Number of Participants With Frequency of Medically Attended Wheezing Events | 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. | The ITT population included all participants in the treatment group according to their randomized treatment group. | Posted | Count of Participants | Participants | Study Day 0 through 3 years |
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| Secondary | Mean Trough Serum Concentrations of Motavizumab | The mean trough serum concentrations of motavizumab are reported. | 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. | Posted | Mean | Standard Deviation | μg/mL | Day 0 (pre Dose 1) and Day 120 (Pre Dose 5) |
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| Secondary | Number of Participants With Positive Anti-Motavizumab Antibodies After Full Dose | The number of participants with positive serum antidrug antibodies (ADAs) to motavizumab after full dose are reported. | 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. | Posted | Count of Participants | Participants | Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5) |
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| Secondary | Number of Participants With Positive Anti-Motavizumab Antibodies After Any Dose | The number of participants with positive serum ADA to motavizumab after any dose are reported. | Evaluable population for any dose included all participants (in season 1 through 3) who received at least 1 dose 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 timepoints. | Posted | Count of Participants | Participants | Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5) |
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From study Day 0 through study Day 150
Safety population included all the participants who received any study drug.
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| 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 intramuscular (IM) dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the respiratory syncytial virus (RSV) season. | 5 | 708 | 148 | 708 | 682 | 708 |
| EG001 | MOTAVIZUMAB | Participants received IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season. | 8 | 1,414 | 212 | 1,414 | 1,345 | 1,414 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Benign familial neonatal convulsions | Congenital, familial and genetic disorders | MedDRA 11.1 | Systematic Assessment |
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| Combined immunodeficiency | Congenital, familial and genetic disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fallot's tetralogy | Congenital, familial and genetic disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Microvillous inclusion disease | Congenital, familial and genetic disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fever neonatal | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia neonatal | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bacterial pyelonephritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Lobar pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Lower respiratory tract infection viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Meningitis candida | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Meningitis pneumococcal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Perineal abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Pneumonia haemophilus | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Pneumonia influenzal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Pneumonia pneumococcal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Pneumonia viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Respiratory syncytial virus infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Urinary tract infection bacterial | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Viral pharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Postoperative fever | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Skull fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Bacterial test | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Blood culture positive | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Laboratory test interference | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Medical observation | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| Failure to thrive | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| Craniosynostosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Synostosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypoxic encephalopathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Subdural hygroma | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Victim of child abuse | Social circumstances | MedDRA 11.1 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dacryostenosis congenital | Congenital, familial and genetic disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Candida nappy rash | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Skin candida | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Viral 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 |
| |
| Cardiac murmur | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue 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 |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Seborrhoea | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
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 is 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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| White Mountain Apache |
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| San Carlos Apache |
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| Zuni |
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| Hopi |
|
| Other - Not specified |
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