Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-31 @ 5:50 AM
Study NCT ID:
NCT01475305
Status:
TERMINATED
Last Update Posted:
2017-07-21
First Post:
2011-10-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intranasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jafrih@medimmune.com', 'phone': '301-398-4431', 'title': 'Hasan Jafri, Medical Director', 'organization': 'Medimmune, LLC'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated before an adequate number of subjects were enrolled.'}}, 'adverseEventsModule': {'timeFrame': 'From Day -2 to Day 360', 'description': 'Safety population included all participants who received any amount of investigational product.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Skeletal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypopnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Rash follicular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Plaque Assay Culture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.'}, {'id': 'OG001', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '0.00', 'ciUpperLimit': '2.05', 'estimateComment': 'Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 4 to Day 15', 'description': 'RSV infection is defined as positive plaque assay culture sample for greater than or equal to (\\>=) 1 day through 12 days post-RSV challenge. A sample was determined positive if log10 plaque-forming units per milliliter \\[pfu/mL\\] greater than or equal lower limit of quantitation (LLOQ; 1.69 log10 pfu/mL) and 2 of the 3 replicates must have greater than (\\>) 0 pfu/mL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for RSV Incidence included all participants who received both the investigational product and RSV challenge.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.'}, {'id': 'OG001', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'title': 'RSV infection by quantitative real-time RT-PCR', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}, {'title': 'RSV infection by DFA', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'RSV infection by Any Method', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.16', 'ciUpperLimit': '6.24', 'estimateComment': 'Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.', 'groupDescription': 'RSV infection by quantitative real-time RT-PCR', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '0.00', 'ciUpperLimit': '2.05', 'estimateComment': 'Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.', 'groupDescription': 'RSV infection by DFA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.16', 'ciUpperLimit': '6.24', 'estimateComment': 'Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.', 'groupDescription': 'RSV infection by Any Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 4 to Day 15', 'description': 'RSV infection defined as positive quantitative real-time RT-PCR (RSV-A only) sample for \\>= 2 consecutive days through 12 days post-RSV challenge. A sample was determined positive if log10 copies/ml \\>= limit of quantitation (LLOQ; 2.80 log10 copies/mL). RSV infection defined as positive DFA sample for \\>= 2 consecutive days through 12 days post-RSV challenge. RSV infection by any method included positive plaque assay culture sample for \\>=1 day through 12 days post-RSV challenge, or positive quantitative real-time RT-PCR (RSV-A only) sample for \\>= 2 consecutive days through 12 days post-RSV challenge, or positive DFA sample for \\>=2 consecutive days through 12 days post-RSV challenge.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for RSV Incidence included all participants who received both the investigational product and RSV challenge.'}, {'type': 'SECONDARY', 'title': 'Mean Viral Load AUC0-t by Plaque Assay Culture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.'}, {'id': 'OG001', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.165', 'spread': '3.305', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 5 through Day 31', 'description': 'RSV infection by plaque assay culture defined as positive sample for \\>= 1 day through 12 days post-RSV challenge.', 'unitOfMeasure': 'log10 pfu*day/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for RSV Plaque Assay Culture Virology included all participants who received both investigational product and RSV challenge and were positive for RSV by plaque assay culture (defined as positive sample for \\>=1 day through 12 days post-RSV challenge).'}, {'type': 'SECONDARY', 'title': 'Mean Viral Load AUC0-t by Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.'}, {'id': 'OG001', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.04', 'spread': '7.000', 'groupId': 'OG000'}, {'value': '65.708', 'spread': '1.488', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 5 through Day 31', 'description': 'RSV infection by plaque assay culture defined as positive sample for \\>= 2 consecutive days through 12 days post-RSV challenge.', 'unitOfMeasure': 'log10 copies*day/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for RSV Quantitative Real-Time RT-PCR Virology included all participants who received both the investigational product and RSV challenge and were positive for RSV-A by quantitative real-time RT-PCR (defined as positive samples for \\>= 2 consecutive days through 12 days post-RSV challenge).'}, {'type': 'SECONDARY', 'title': 'Mean Nasal RSV Peak as Measured by Plaque Assay Culture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.'}, {'id': 'OG001', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.150', 'spread': '0.521', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 5 through Day 31', 'description': 'RSV infection by plaque assay culture defined as positive sample for \\>= 1 day through 12 days post-RSV challenge. log10 pfu/mL = log10 plaque-forming unit per milliliter.', 'unitOfMeasure': 'log10 pfu/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for RSV Plaque Assay Culture Virology included all participants who received both investigational product and RSV challenge and were positive for RSV by plaque assay culture (defined as positive sample for \\>= 1 day through 12 days post-RSV challenge).'}, {'type': 'SECONDARY', 'title': 'Mean Nasal RSV Peak as Measured by Quantitative Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.'}, {'id': 'OG001', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.700', 'spread': '0.453', 'groupId': 'OG000'}, {'value': '4.260', 'spread': '0.863', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 5 through Day 31', 'description': 'RSV infection by plaque assay culture defined as positive sample for \\>= 2 consecutive days through 12 days post-RSV challenge.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for RSV Quantitative Real-Time RT-PCR Virology included all participants who received both the investigational product and RSV challenge and were positive for RSV-A by quantitative real-time RT-PCR (defined as positive samples for \\>= 2 consecutive days through 12 days post-RSV challenge).'}, {'type': 'SECONDARY', 'title': 'Duration of Respiratory Syncytial Virus (RSV) Viral Shedding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.'}, {'id': 'OG001', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'spread': '0.0', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '10'}, {'value': '6.5', 'spread': '4.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '11'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 5 through Day 31', 'description': 'Duration of viral shedding defined as the number of days from the first sample positive by any assay (that is, plaque assay culture, quantitative real-time (RT-PCR), or direct fluorescent Antibody (DFA) to the last sample positive by any assay.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for RSV Incidence by any Viral Assay included all participants who received both the investigational product and RSV challenge and were positive for RSV by plaque assay culture, quantitative real-time RT-PCR, or DFA.'}, {'type': 'SECONDARY', 'title': 'Mean Serum MEDI-557 Concentration Through Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'title': 'Day 1 (pre-dose) (n=3)', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': '1 hr Post-dose (n=3)', 'categories': [{'measurements': [{'value': '498.730', 'spread': '6.615', 'groupId': 'OG000'}]}]}, {'title': '4 hr Post-dose (n=3)', 'categories': [{'measurements': [{'value': '462.937', 'spread': '40.212', 'groupId': 'OG000'}]}]}, {'title': '8 hr Post-dose (n=3)', 'categories': [{'measurements': [{'value': '458.413', 'spread': '40.613', 'groupId': 'OG000'}]}]}, {'title': 'Day 2 (n=3)', 'categories': [{'measurements': [{'value': '407.627', 'spread': '13.420', 'groupId': 'OG000'}]}]}, {'title': 'Day 3 (n=3)', 'categories': [{'measurements': [{'value': '343.283', 'spread': '48.078', 'groupId': 'OG000'}]}]}, {'title': 'Day 5 (n=3)', 'categories': [{'measurements': [{'value': '298.020', 'spread': '48.966', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 (n=3)', 'categories': [{'measurements': [{'value': '287.917', 'spread': '39.276', 'groupId': 'OG000'}]}]}, {'title': 'Day 9 (n=3)', 'categories': [{'measurements': [{'value': '293.897', 'spread': '33.128', 'groupId': 'OG000'}]}]}, {'title': 'Day 11(n=3)', 'categories': [{'measurements': [{'value': '265.107', 'spread': '24.076', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (n=3)', 'categories': [{'measurements': [{'value': '252.327', 'spread': '16.091', 'groupId': 'OG000'}]}]}, {'title': 'Day 31 (n=3)', 'categories': [{'measurements': [{'value': '252.177', 'spread': '23.225', 'groupId': 'OG000'}]}]}, {'title': 'Day 61 (n=2)', 'categories': [{'measurements': [{'value': '180.505', 'spread': '6.442', 'groupId': 'OG000'}]}]}, {'title': 'Day 91 (n=3)', 'categories': [{'measurements': [{'value': '131.053', 'spread': '4.571', 'groupId': 'OG000'}]}]}, {'title': 'Day 120 (n=3)', 'categories': [{'measurements': [{'value': '106.040', 'spread': '10.023', 'groupId': 'OG000'}]}]}, {'title': 'Day 150 (n=3)', 'categories': [{'measurements': [{'value': '75.583', 'spread': '11.258', 'groupId': 'OG000'}]}]}, {'title': 'Day 180 (n=3)', 'categories': [{'measurements': [{'value': '65.443', 'spread': '5.897', 'groupId': 'OG000'}]}]}, {'title': 'Day 240 (n=2)', 'categories': [{'measurements': [{'value': '43.875', 'spread': '6.428', 'groupId': 'OG000'}]}]}, {'title': 'Day 300 (n=3)', 'categories': [{'measurements': [{'value': '31.353', 'spread': '5.731', 'groupId': 'OG000'}]}]}, {'title': 'Day 360 (n=3)', 'categories': [{'measurements': [{'value': '20.343', 'spread': '4.138', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360', 'description': 'MEDI-557 serum concentrations were summarized by each sampling point \\[LLOQ for MEDI-557 concentration assay was 1.56 microgram per millilitre (μg/mL) for serum\\].', 'unitOfMeasure': 'microgram per milliliter (ug/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for PK included all participants who received a full dose of investigational product and had \\>= 1 post-baseline measurement for PK. Here n = participants evaluable for specified categories, for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Maximum Serum Concentration (Cmax) of MEDI-557', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '504.0433', 'spread': '6.6189', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360', 'description': 'The Cmax is the maximum observed serum concentration of MEDI-557.', 'unitOfMeasure': 'microgram per milliliter (mcg/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for PK included all participants who received a full dose of investigational product and had \\>= 1 post-baseline measurement for PK.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Serum Concentration (Tmax) of MEDI-557', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.162', 'spread': '0.068', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360', 'description': 'The Tmax is defined as actual sampling time to reach maximum observed MEDI-557 concentration.', 'unitOfMeasure': 'Day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for PK included all participants who received a full dose of investigational product and had \\>= 1 post-baseline measurement for PK.'}, {'type': 'SECONDARY', 'title': 'Serum Half Life (t1/2) of MEDI-557', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.0029426', 'spread': '93.8412056', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360', 'description': 'Serum decay half-life is the time measured for the serum concentration to decrease by one half.', 'unitOfMeasure': 'Day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for PK included all participants who received a full dose of investigational product and had \\>= 1 post-baseline measurement for PK.'}, {'type': 'SECONDARY', 'title': "Area Under the Serum Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557", 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '34484.8642', 'spread': '1114.4471', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360', 'description': "The AUC(0-t) is the area under the serum concentration-time curve from time zero to any time 't'.", 'unitOfMeasure': 'day*microgram per milliliter (d*mcg/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for PK included all participants who received a full dose of investigational product and had \\>= 1 post-baseline measurement for PK.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of MEDI-557', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '37266.5740', 'spread': '1764.7070', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360', 'description': 'The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.', 'unitOfMeasure': 'd*mcg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for PK included all participants who received a full dose of investigational product and had \\>= 1 post-baseline measurement for PK.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution at Steady-State (Vss) of MEDI-557', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '6644.3433', 'spread': '606.4269', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC\\[0-infinity\\])\\*(AUMC\\[0-infinity\\])/AUC\\[0-infinity\\]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the serum concentration-time curve from time zero to infinite time.', 'unitOfMeasure': 'milliliter (ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for PK included all participants who received a full dose of investigational product and had \\>= 1 post-baseline measurement for PK.'}, {'type': 'SECONDARY', 'title': 'Mean Clearance of MEDI-557', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.3831', 'spread': '4.6158', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360', 'description': 'Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the serum Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC\\[0-infinity\\]).', 'unitOfMeasure': 'milliliter per day (ml/d)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for PK included all participants who received a full dose of investigational product and had \\>= 1 post-baseline measurement for PK.'}, {'type': 'SECONDARY', 'title': 'Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'title': 'Day 1 (pre-dose)', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '166.613', 'spread': '8.257', 'groupId': 'OG000'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '192.827', 'spread': '160.257', 'groupId': 'OG000'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '189.767', 'spread': '87.745', 'groupId': 'OG000'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '227.980', 'spread': '189.806', 'groupId': 'OG000'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '308.153', 'spread': '173.823', 'groupId': 'OG000'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '201.647', 'spread': '105.288', 'groupId': 'OG000'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '132.407', 'spread': '134.702', 'groupId': 'OG000'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '220.953', 'spread': '58.505', 'groupId': 'OG000'}]}]}, {'title': 'Day 12', 'categories': [{'measurements': [{'value': '262.800', 'spread': '310.692', 'groupId': 'OG000'}]}]}, {'title': 'Day 13', 'categories': [{'measurements': [{'value': '89.867', 'spread': '72.249', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '184.747', 'spread': '260.718', 'groupId': 'OG000'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '243.567', 'spread': '251.884', 'groupId': 'OG000'}]}]}, {'title': 'Day 31', 'categories': [{'measurements': [{'value': '62.707', 'spread': '62.348', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31', 'description': 'MEDI-557 nasal wash concentrations were summarized by each sampling point \\[LLOQ for MEDI-557 concentration assay was 20.00 nanogram per millilitre (ng/mL) for nasal wash\\].', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for PK included all participants who received a full dose of investigational product and had \\>= 1 post-baseline measurement for PK.'}, {'type': 'SECONDARY', 'title': 'Maximum Nasal Wash Concentration (Cmax) of MEDI-557', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '377.9800', 'spread': '212.2542', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31', 'description': 'The Cmax is the maximum observed nasal wash concentration of MEDI-557.', 'unitOfMeasure': 'nanogram per milliliter (ng/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for PK included all participants who received a full dose of investigational product and had \\>= 1 post-baseline measurement for PK.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Nasal Wash Concentration (Tmax) of MEDI-557', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.051', 'spread': '2.113', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31', 'description': 'The Tmax is defined as actual sampling time to reach maximum observed MEDI-557 concentration.', 'unitOfMeasure': 'Day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for PK included all participants who received a full dose of investigational product and had \\>= 1 post-baseline measurement for PK.'}, {'type': 'SECONDARY', 'title': "Area Under the Nasal Wash Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557", 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '4541.3636', 'spread': '3905.7874', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31', 'description': "The AUC(0-t) is the area under the nasal wash concentration-time curve from time zero to any time 't'.", 'unitOfMeasure': 'day*nanogram per milliliter (d*ng/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for PK included all participants who received a full dose of investigational product and had \\>= 1 post-baseline measurement for PK.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Positive Anti-MEDI-557 Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.'}, {'id': 'OG001', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'title': 'Day 1 (pre-dose) (n=4,3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 31 (n=4,3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 91 (n=4,3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 150 (n=3,3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 180 (n=4,3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 240 (n=3,2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 300 (n=4,3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 360 (n=4,3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (pre-dose); Day 31, 91, 150, 180, 240, 300 and 360 post-dose', 'description': 'Anti-drug antibodies in the participants blood sample were detected using a validated immunoassay. Antidrug antibodies to MEDI-557 were defined as a detectable antibody titer with a dilution value of 1:30 or greater.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for ADA included all participants who received any amount of investigational product and had \\>= 1 post-baseline measurement for ADA. Here, "n" is number of participants analysed at specific time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.'}, {'id': 'OG001', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 (immediately following administration of study drug) to Day 360', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was 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. Treatment-emergent were events between first dose of study drug and Day 360 that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received any amount of investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Vital Signs Abnormalities Reported as Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.'}, {'id': 'OG001', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 through Day 31', 'description': 'Vital signs included temperature, respiration rate, heart rate, blood pressure. Abnormal vital sign parameters included Cardiac Disorders (Bradycardia), Respiratory, Thoracic and Mediastinal Disorders (Tachypnoea, Hyperventilation, Hypopnoea). Participants with abnormalities in these vital Signs investigations recorded as AEs were reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received any amount of investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.'}, {'id': 'OG001', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'title': 'Hematology', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Coagulation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serum chemistry', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Urinalysis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac enzymes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 through Day 91', 'description': 'Laboratory investigations included hematology, coagulation, serum chemistry and urinalysis parameters. Participants with abnormalities in these laboratory investigations recorded as AEs were reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received any amount of investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Meaningful Changes From Baseline in Spirometry Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.'}, {'id': 'OG001', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1, 2, 3 (Baseline), 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 31', 'description': 'Spirometry is a standardized assessment to evaluate lung function. Baseline values for spirometry is defined as the last measure prior to viral challenge. Spirometry assessments included percent predicted forced expiratory volume in 1 second (FEV1), FEV1/forced vital capacity (FVC), and forced expiratory flow (FEF) 25%-75% values.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received any amount of investigational product.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.'}, {'id': 'FG001', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'End of Quarantine, Day 15', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 90 participants were screened, out of these, 7 participants were randomized and completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.'}, {'id': 'BG001', 'title': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.5', 'spread': '4.4', 'groupId': 'BG000'}, {'value': '28.0', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '26.0', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent-to-treat (ITT) population included all participants who were randomized into the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'The study was terminated as it was determined to not be feasible to complete enrollment and the study within the required timeline and budget.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2012-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-20', 'studyFirstSubmitDate': '2011-10-14', 'resultsFirstSubmitDate': '2017-04-05', 'studyFirstSubmitQcDate': '2011-11-16', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-20', 'studyFirstPostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Plaque Assay Culture', 'timeFrame': 'From Day 4 to Day 15', 'description': 'RSV infection is defined as positive plaque assay culture sample for greater than or equal to (\\>=) 1 day through 12 days post-RSV challenge. A sample was determined positive if log10 plaque-forming units per milliliter \\[pfu/mL\\] greater than or equal lower limit of quantitation (LLOQ; 1.69 log10 pfu/mL) and 2 of the 3 replicates must have greater than (\\>) 0 pfu/mL.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method', 'timeFrame': 'From Day 4 to Day 15', 'description': 'RSV infection defined as positive quantitative real-time RT-PCR (RSV-A only) sample for \\>= 2 consecutive days through 12 days post-RSV challenge. A sample was determined positive if log10 copies/ml \\>= limit of quantitation (LLOQ; 2.80 log10 copies/mL). RSV infection defined as positive DFA sample for \\>= 2 consecutive days through 12 days post-RSV challenge. RSV infection by any method included positive plaque assay culture sample for \\>=1 day through 12 days post-RSV challenge, or positive quantitative real-time RT-PCR (RSV-A only) sample for \\>= 2 consecutive days through 12 days post-RSV challenge, or positive DFA sample for \\>=2 consecutive days through 12 days post-RSV challenge.'}, {'measure': 'Mean Viral Load AUC0-t by Plaque Assay Culture', 'timeFrame': 'From Day 5 through Day 31', 'description': 'RSV infection by plaque assay culture defined as positive sample for \\>= 1 day through 12 days post-RSV challenge.'}, {'measure': 'Mean Viral Load AUC0-t by Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)', 'timeFrame': 'From Day 5 through Day 31', 'description': 'RSV infection by plaque assay culture defined as positive sample for \\>= 2 consecutive days through 12 days post-RSV challenge.'}, {'measure': 'Mean Nasal RSV Peak as Measured by Plaque Assay Culture', 'timeFrame': 'From Day 5 through Day 31', 'description': 'RSV infection by plaque assay culture defined as positive sample for \\>= 1 day through 12 days post-RSV challenge. log10 pfu/mL = log10 plaque-forming unit per milliliter.'}, {'measure': 'Mean Nasal RSV Peak as Measured by Quantitative Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)', 'timeFrame': 'From Day 5 through Day 31', 'description': 'RSV infection by plaque assay culture defined as positive sample for \\>= 2 consecutive days through 12 days post-RSV challenge.'}, {'measure': 'Duration of Respiratory Syncytial Virus (RSV) Viral Shedding', 'timeFrame': 'From Day 5 through Day 31', 'description': 'Duration of viral shedding defined as the number of days from the first sample positive by any assay (that is, plaque assay culture, quantitative real-time (RT-PCR), or direct fluorescent Antibody (DFA) to the last sample positive by any assay.'}, {'measure': 'Mean Serum MEDI-557 Concentration Through Day 360', 'timeFrame': 'Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360', 'description': 'MEDI-557 serum concentrations were summarized by each sampling point \\[LLOQ for MEDI-557 concentration assay was 1.56 microgram per millilitre (μg/mL) for serum\\].'}, {'measure': 'Maximum Serum Concentration (Cmax) of MEDI-557', 'timeFrame': 'Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360', 'description': 'The Cmax is the maximum observed serum concentration of MEDI-557.'}, {'measure': 'Time to Reach Maximum Serum Concentration (Tmax) of MEDI-557', 'timeFrame': 'Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360', 'description': 'The Tmax is defined as actual sampling time to reach maximum observed MEDI-557 concentration.'}, {'measure': 'Serum Half Life (t1/2) of MEDI-557', 'timeFrame': 'Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360', 'description': 'Serum decay half-life is the time measured for the serum concentration to decrease by one half.'}, {'measure': "Area Under the Serum Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557", 'timeFrame': 'Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360', 'description': "The AUC(0-t) is the area under the serum concentration-time curve from time zero to any time 't'."}, {'measure': 'Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of MEDI-557', 'timeFrame': 'Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360', 'description': 'The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.'}, {'measure': 'Volume of Distribution at Steady-State (Vss) of MEDI-557', 'timeFrame': 'Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC\\[0-infinity\\])\\*(AUMC\\[0-infinity\\])/AUC\\[0-infinity\\]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the serum concentration-time curve from time zero to infinite time.'}, {'measure': 'Mean Clearance of MEDI-557', 'timeFrame': 'Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360', 'description': 'Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the serum Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC\\[0-infinity\\]).'}, {'measure': 'Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points', 'timeFrame': 'Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31', 'description': 'MEDI-557 nasal wash concentrations were summarized by each sampling point \\[LLOQ for MEDI-557 concentration assay was 20.00 nanogram per millilitre (ng/mL) for nasal wash\\].'}, {'measure': 'Maximum Nasal Wash Concentration (Cmax) of MEDI-557', 'timeFrame': 'Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31', 'description': 'The Cmax is the maximum observed nasal wash concentration of MEDI-557.'}, {'measure': 'Time to Reach Maximum Nasal Wash Concentration (Tmax) of MEDI-557', 'timeFrame': 'Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31', 'description': 'The Tmax is defined as actual sampling time to reach maximum observed MEDI-557 concentration.'}, {'measure': "Area Under the Nasal Wash Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557", 'timeFrame': 'Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31', 'description': "The AUC(0-t) is the area under the nasal wash concentration-time curve from time zero to any time 't'."}, {'measure': 'Percentage of Participants With Positive Anti-MEDI-557 Antibodies', 'timeFrame': 'Day 1 (pre-dose); Day 31, 91, 150, 180, 240, 300 and 360 post-dose', 'description': 'Anti-drug antibodies in the participants blood sample were detected using a validated immunoassay. Antidrug antibodies to MEDI-557 were defined as a detectable antibody titer with a dilution value of 1:30 or greater.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From Day 1 (immediately following administration of study drug) to Day 360', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was 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. Treatment-emergent were events between first dose of study drug and Day 360 that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With Vital Signs Abnormalities Reported as Adverse Events (AEs)', 'timeFrame': 'From Day 1 through Day 31', 'description': 'Vital signs included temperature, respiration rate, heart rate, blood pressure. Abnormal vital sign parameters included Cardiac Disorders (Bradycardia), Respiratory, Thoracic and Mediastinal Disorders (Tachypnoea, Hyperventilation, Hypopnoea). Participants with abnormalities in these vital Signs investigations recorded as AEs were reported.'}, {'measure': 'Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs)', 'timeFrame': 'From Day 1 through Day 91', 'description': 'Laboratory investigations included hematology, coagulation, serum chemistry and urinalysis parameters. Participants with abnormalities in these laboratory investigations recorded as AEs were reported.'}, {'measure': 'Number of Participants With Clinically Meaningful Changes From Baseline in Spirometry Values', 'timeFrame': 'Days 1, 2, 3 (Baseline), 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 31', 'description': 'Spirometry is a standardized assessment to evaluate lung function. Baseline values for spirometry is defined as the last measure prior to viral challenge. Spirometry assessments included percent predicted forced expiratory volume in 1 second (FEV1), FEV1/forced vital capacity (FVC), and forced expiratory flow (FEF) 25%-75% values.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Respiratory Syncytial Virus (RSV)', 'Healthy adults', 'MEDI-557', 'Intranasal challenge', 'Human model'], 'conditions': ['RSV Infection']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the suitability of the challenge model in measuring the efficacy of MEDI-557 compared to placebo in healthy adult participants for the reduction in the incidence of RSV through 12 days post-RSV challenge with the RSV Memphis-37 strain.', 'detailedDescription': 'This is designed to be a double-blind, placebo-controlled, randomized study. Approximately 30 participants will be randomized, dosed and followed. Participants will be randomly assigned to receive a single intravenous (IV) dose of MEDI-557 or placebo. Participants will be inoculated with RSV-A. Participants will be followed for efficacy for 12 days post-RSV challenge. Safety follow-up will be approximately 12 months from randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy as determined by medical history and physical examination.\n2. Age 19 through 38 years at the time of screening.\n3. Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.\n4. Weight less than or equal to (\\<=) 10 kilogram (kg) with body mass index (BMI) less than (\\<) 32 kilogram per meter square (kg/m\\^2).\n5. Normotensive (systolic blood pressure \\[BP\\] \\<150 millimeters of mercury (mmHg) and diastolic BP \\< 90 mmHg).\n6. Females of childbearing age using contraception.\n7. Males who are sexually active with a female partner of childbearing potential, using contraception.\n8. Sero-suitable (that is, low serum RSV neutralizing antibody titre) for RSV infection.\n\nExclusion Criteria:\n\nCurrent medical conditions as follows:\n\n1. Clinical evidence of chronic pulmonary disease or any use of a bronchodilator or other asthma medication.\n2. Current smoker unwilling/unable to desist for the quarantine phase of the study.\n3. History or clinical evidence of recurrent lower respiratory tract infection.\n4. Evidence of infection with hepatitis A, B, or C virus or human immunodeficiency virus (HIV) by serology.\n\n Medical history as follows:\n5. History of immunodeficiency.\n6. History of chronic sinusitis.\n7. History of frequent epistaxis.\n8. History of or current diagnosis of diabetes.\n9. Prior/concomitant therapy including\n\n * Receipt of any systemic chemotherapeutic agent at any time;\n * Receipt of systemic glucocorticoids within 1 month, or any other immunosuppressive drug within 6 months prior to challenge.\n * Receipt of any investigational drug within 6 months prior to dose or concurrent enrolment in another clinical study.\n * Prior participation in a clinical trial of any experimental RSV viral challenge delivered directly to the respiratory tract at any time, or any other respiratory virus challenge within 1 year prior to dose.\n10. Nursing mother.\n11. Alcohol or drug addiction/abuse within the past 2 years.\n12. A positive urine Class A drug or alcohol screen unless there is a medical reason.\n13. History of seasonal hay fever or seasonal allergies.\n14. Employees of the clinical study site or sponsor, any other individuals involved with the conduct of the study, or immediate family members of such individuals.\n15. Health care workers anticipated to have patient contact within 2 weeks after viral challenge.\n16. Participants who, for an additional 2 weeks after discharge from the isolation facility, are likely to have contact with a household member or close contact with someone who is: (a) less than 3 years of age; (b) any person with any known immunodeficiency; (c) any person receiving immunosuppressant medications; (d) any person undergoing or soon to undergo cancer chemotherapy within 28 days of challenge; (e) any person who has diagnosed emphysema or COPD, is elderly residing in a nursing home, or with severe lung disease or medical condition; or (f) any person who has received a transplant (bone marrow or solid organ).\n17. As a result of the medical interview, physical examination, or screening investigations, the investigator(s) considers the participant unfit for the study.'}, 'identificationModule': {'nctId': 'NCT01475305', 'briefTitle': 'Intranasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV)', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 1 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of MEDI-557 in Healthy Adults Intranasally Challenged With Respiratory Syncytial Virus (RSV)', 'orgStudyIdInfo': {'id': 'CD-ID-MEDI-557-1090'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-557', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.', 'interventionNames': ['Drug: MEDI-557']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.', 'armGroupLabels': ['Placebo']}, {'name': 'MEDI-557', 'type': 'DRUG', 'description': 'Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.', 'armGroupLabels': ['MEDI-557']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1 2AX', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Hasan Jafri, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}