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This was a non-interventional, prospective, multi-center study with no control group designed to assess the effectiveness of palivizumab in a population of infants at high-risk of serious Respiratory Syncytial Virus (RSV) illness (infants born ≤ 35 weeks of gestation and infants ≤24 months with Bronchopulmonary Dysplasia (BPD) or Congenital Heart Disease (CHD)). Participants received immunoprophylaxis during the RSV season, defined as October 2014 through April 2015, in routine clinical settings throughout the Russian Federation.
Participants received intramuscular injections of palivizumab according to physicians' prescription and the local label. The local label recommended 1 month injection intervals between 5 sequential injections at a dose of 15 mg/kg. Participants could have received from 3 to 5 monthly injections of palivizumab during the 2014 - 2015 RSV season and the duration of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infants at high-risk of serious RSV illness | Infants who received immunoprophylaxis during the RSV season |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test | Hospitalizations for LRTI with positive RSV diagnostic tests were documented at study visits. | Approximately 7 months |
| Proportion of Infants Who Died From a Confirmed Respiratory Syncytial Virus (RSV) Infection | Deaths caused by RSV during the study were to be confirmed by autopsy or clinical history and positive virologic diagnostic tests. | Approximately 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test | The duration of hospitalizations due to LRTI which were accompanied by a positive RSV diagnostic test was documented. | Approximately 7 months |
| Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants |
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Inclusion Criteria:
Planned prescription of palivizumab for immunoprophylaxis during RSV season or participants for whom palivizumab was prescribed and who received the first dose of palivizumab no later than 60 days before enrollment in the study
Infants at high risk of severe RSV infection defined as fulfilling at least one of the following:
Written authorization to use individual data signed by parents or child representative
Exclusion Criteria:
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Infants at high-risk of serious Respiratory Syncytial Virus (RSV) illness (infants born ≤ 35 weeks of gestation and infants ≤24 months with Bronchopulmonary Dysplasia (BPD) or Congenital Heart Disease (CHD)) who received immunoprophylaxis during the RSV season defined as October 2014 through April 2015 in routine clinical settings in the Russian Federation.
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| Name | Affiliation | Role |
|---|---|---|
| Andrey Strugovschikov, MD | AbbVie | Study Director |
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| Label | URL |
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| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Infants at High-risk of Serious RSV Illness | Infants who received immunoprophylaxis during the RSV season |
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| Overall Study |
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The number of hospitalized participants admitted to the Intensive Care Unit was documented. |
| Approximately 7 months |
| Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU) | The median length of stay of hospitalized participants in the Intensive Care Unit was calculated. | Approximately 7 months |
| Proportion of Participants Who Received Supplemental Oxygen While Hospitalized | The proportion of participants who received supplemental oxygen while hospitalized was documented. | Approximately 7 months |
| Proportion of Participants Who Received Mechanical Ventilation While Hospitalized | The proportion of participants who received mechanical ventilation while hospitalized was documented. | Approximately 7 months |
| Proportion of Participants With Missed Doses of Palivizumab | The proportion of participants with missed or delayed doses of palivizumab was documented. | Approximately 7 months |
| Proportion of Participants With Co-morbidities During Hospitalizations | The proportion of participants with co-morbidities during hospitalizations was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10). | Approximately 7 months |
| Median Duration of Mechanical Ventilation Administration During Hospitalizations | The median duration of mechanical ventilation administration during hospitalizations was calculated. | Approximately 7 months |
| Median Duration of Oxygen Administration During Hospitalizations | The median duration of mechanical oxygen administration during hospitalizations was calculated. | Approximately 7 months |
| Proportion of Participants With a Particular Co-morbidity | The proportion of participants with co-morbidities was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10). | Approximately 7 months |
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Infants who received immunoprophylaxis during the RSV season
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| ID | Title | Description |
|---|---|---|
| BG000 | Infants at High-risk of Serious RSV Illness | Infants who received immunoprophylaxis during the RSV season |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test | Hospitalizations for LRTI with positive RSV diagnostic tests were documented at study visits. | Infants who received immunoprophylaxis during the RSV season | Posted | Number | participants | Approximately 7 months |
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| Primary | Proportion of Infants Who Died From a Confirmed Respiratory Syncytial Virus (RSV) Infection | Deaths caused by RSV during the study were to be confirmed by autopsy or clinical history and positive virologic diagnostic tests. | Infants who received immunoprophylaxis during the RSV season | Posted | Number | participants | Approximately 7 months |
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| Secondary | Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test | The duration of hospitalizations due to LRTI which were accompanied by a positive RSV diagnostic test was documented. | Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test | Posted | Median | Full Range | days | Approximately 7 months |
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| Secondary | Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants | The number of hospitalized participants admitted to the Intensive Care Unit was documented. | Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test | Posted | Number | participants | Approximately 7 months |
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| Secondary | Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU) | The median length of stay of hospitalized participants in the Intensive Care Unit was calculated. | Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test | Posted | Median | Full Range | days | Approximately 7 months |
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| Secondary | Proportion of Participants Who Received Supplemental Oxygen While Hospitalized | The proportion of participants who received supplemental oxygen while hospitalized was documented. | Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test | Posted | Number | participants | Approximately 7 months |
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| Secondary | Proportion of Participants Who Received Mechanical Ventilation While Hospitalized | The proportion of participants who received mechanical ventilation while hospitalized was documented. | Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test | Posted | Number | participants | Approximately 7 months |
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| Secondary | Proportion of Participants With Missed Doses of Palivizumab | The proportion of participants with missed or delayed doses of palivizumab was documented. | Infants who received immunoprophylaxis during the RSV season | Posted | Number | participants | Approximately 7 months |
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| Secondary | Proportion of Participants With Co-morbidities During Hospitalizations | The proportion of participants with co-morbidities during hospitalizations was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10). | Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test | Posted | Number | participants | Approximately 7 months |
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| Secondary | Median Duration of Mechanical Ventilation Administration During Hospitalizations | The median duration of mechanical ventilation administration during hospitalizations was calculated. | Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test | Posted | Median | Full Range | days | Approximately 7 months |
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| Secondary | Median Duration of Oxygen Administration During Hospitalizations | The median duration of mechanical oxygen administration during hospitalizations was calculated. | Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test | Posted | Median | Full Range | days | Approximately 7 months |
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| Secondary | Proportion of Participants With a Particular Co-morbidity | The proportion of participants with co-morbidities was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10). | Infants who received immunoprophylaxis during the RSV season | Posted | Number | participants | Approximately 7 months |
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Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks.
Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
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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) |
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| EG000 | Infants at High-risk of Serious RSV Illness | Infants who received immunoprophylaxis during the RSV season | 17 | 359 | 0 | 359 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Respiratory tract infection viral | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Otitis media acute | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Meningitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Brain oedema | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Hydrocephalus | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Periventricular leukomalacia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
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| Haemorrhagic disorder | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
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| Myocarditis | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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| Connective tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
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| Global Medical Services | AbbVie | 800-633-9110 |
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| History of bronchopulmonary dysplasia |
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| History of congenital heart disease |
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