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The primary objective of this study was to determine the effect on immune reactivity to motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524) administered for a second season in children.
This was a Phase 1/2, randomized, double-blind study in which motavizumab (MEDI-524) or palivizumab was administered to children who previously participated in MI-CP104. Children who received at least 3 doses of motavizumab in MI-CP104 were eligible for enrollment. Subjects were randomized 1:1 to receive motavizumab or palivizumab at 15 mg/kg by IM injection every 30 days for a total of 4-5 injections during the 2004-05 RSV season subsequent to the season in which they were participants of MI-CP104. All subjects were evaluated prior to and 30 minutes after each injection of study drug with 2 follow-up evaluations, one at 30 days and the other at 90-120 days after the last dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| motavizumab (MEDI-524) 15 mg/kg | Experimental | A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled. |
|
| palivizumab 15 mg/kg | Active Comparator | A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| motavizumab (MEDI-524) | Biological | Patients will receive 15 mg/kg MEDI-524 administered IM every 30 days for a total of 4-5 injections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Exhibiting Anti-motavizumab Antibodies | Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose. | Day 0 through 120 days post final dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Adverse Events (AEs) | Assessments of adverse events (including SAEs) were made by clinical investigators according to the protocol. | Day 0 through 30 days post final dose |
| Number of Subjects Reporting Serious Adverse Events (SAEs) |
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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 |
|---|---|---|---|---|---|---|
| Pontificia Universidade Catolica Do Rio Grande | Porto Alegre | 90610-000 | Brazil | |||
| Hospital Das Clinicas Da Faculdade |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19258920 | Result | Abarca K, Jung E, Fernandez P, Zhao L, Harris B, Connor EM, Losonsky GA; Motavizumab Study Group. Safety, tolerability, pharmacokinetics, and immunogenicity of motavizumab, a humanized, enhanced-potency monoclonal antibody for the prevention of respiratory syncytial virus infection in at-risk children. Pediatr Infect Dis J. 2009 Apr;28(4):267-72. doi: 10.1097/INF.0b013e31818ffd03. |
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Motavizumab or palivizumab was administered to children, using a 1:1 randomization, at 15 mg/kg of study drug by IM injection every 30 days, for a total of 4-5 doses (determined by when in the RSV season a child was enrolled) during the 2005-2006 RSV season.
Children who received at least 3 doses of motavizumab in Study MI-CP104 during the 2004-2005 RSV season were eligible for enrollment in this study. It was anticipated that approximately 150 children would be enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Motavizumab (MEDI-524) 15 mg/kg | A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled. |
| FG001 | Palivizumab 15 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| palivizumab 15 mg/kg | Biological | Patients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections. |
|
|
Assessments of SAEs were made by clinical investigators according to the protocol. |
| Day 0 through 30 days post final dose |
| Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations | Serum chemistry and hematology parameters were measured at baseline, on Days 25-30 and 120, 30 days post the final dose, and at premature discontinuation. | Day 0 through 30 days post final dose |
| Motavizumab Serum Concentrations at Each Data Collection Visit | Mean serum concentration. | Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose |
| Ribeirão Preto |
| 14049-900 |
| Brazil |
| Hospital Clinico De La Pointificia Universidad | Santiago | Chile |
| Hospital Clinico de la Universidad de Chile | Santiago | Chile |
| Hospital Dr. Sotero Del Rio | Santiago | Chile |
| Hospital San Jose | Santiago | Chile |
A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Motavizumab (MEDI-524) 15 mg/kg | A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled. |
| BG001 | Palivizumab 15 mg/kg | A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled. |
| 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 | Number | 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 Subjects Exhibiting Anti-motavizumab Antibodies | Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose. | All subjects who received any study drug were included in all summaries of immunogenicity. Day 0 n=66 mota, n=70 pali; Day 25-30 n=65 mota, n=69 pali; Day 120 n=64 mota, n=67 pali; 30 days post final dose n=65 mota, n=67 pali; 90-120 days post final dose n=64 mota, n=67 pali; at any time n=66 mota, n=70 pali. | Posted | Number | participants | Day 0 through 120 days post final dose |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Adverse Events (AEs) | Assessments of adverse events (including SAEs) were made by clinical investigators according to the protocol. | All subjects who received any study drug were included in all summaries of safety. | Posted | Number | participants | Day 0 through 30 days post final dose |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | Assessments of SAEs were made by clinical investigators according to the protocol. | All subjects who received any study drug were included in all summaries of safety. | Posted | Number | participants | Day 0 through 30 days post final dose |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations | Serum chemistry and hematology parameters were measured at baseline, on Days 25-30 and 120, 30 days post the final dose, and at premature discontinuation. | All subjects who received any study drug were included in all summaries of safety. | Posted | Number | participants | Day 0 through 30 days post final dose |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Motavizumab Serum Concentrations at Each Data Collection Visit | Mean serum concentration. | All subjects who received any study drug were included in all summaries. Day 0 n= 66; Day 25-30 n=65; Day 120 n=63; 30 days post final dose n=63; 90-120 days post final dose n=62 | Posted | Mean | Standard Deviation | ug/mL | Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose |
|
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Day 0 through 30 days post final dose.
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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 | Motavizumab (MEDI-524) 15 mg/kg | A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled. | 4 | 66 | 56 | 66 | ||
| EG001 | Palivizumab 15 mg/kg | A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled. | 1 | 70 | 62 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BRONCHITIS | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| PNEUMONITIS CHEMICAL | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| THERMAL BURN | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| BLOOD UREA INCREASED | Investigations | 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 |
| |
| CONJUNCTIVITIS | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| DERMATITIS ATOPIC | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| DERMATITIS DIAPER | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| EOSINOPHILIA | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| IMMUNISATION REACTION | Immune system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| INJECTION SITE ERYTHEMA | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| LARYNGITIS | 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 |
| |
| OTITIS MEDIA ACUTE | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| PRURIGO | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| TONSILLITIS | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| VARICELLA | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| WHEEZING | Respiratory, thoracic and mediastinal 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 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 | |
|---|---|---|---|---|
| M. Pamela Griffin, MD/ Clinical Development | MedImmune | 301-398-0000 | clinicaltrialenquiries@medimmune.com |
| ID | Term |
|---|---|
| C506968 | motavizumab |
| D000069455 | Palivizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Male |
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| White/Non-Hispanic |
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| Other |
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| Day 120 |
|
| 30 Days Post Final Dose |
|
| 90-120 Days Post Final Dose |
|
| At any time |
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