Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-03-28 @ 11:30 AM
Study NCT ID:
NCT00112112
Status:
COMPLETED
Last Update Posted:
2017-08-14
First Post:
2005-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study to Evaluate FluMist in Immunocompromised Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613429', 'term': 'FluMist'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'malloryr@medimmune.com', 'phone': '301-398-0000', 'title': 'Raburn Mallory', '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.The principal investigators (PIs) also agree for data to be presented first as a joint, multi-center publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).', 'otherNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.', 'otherNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Animal scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oral intake reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypoaesthesia facial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Skin chapped', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Had Reactogenicity Events (REs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-42 days after study vaccination', 'description': 'Reactogenicity events (REs) are predefined solicited adverse events (AEs) that can potentially occur after vaccine administration. The REs for this study included fever, runny nose/nasal congestion, sore throat, cough, vomiting, headache, muscle aches, chills, tiredness, and irritability.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received any study vaccine and had any follow-up for REs and/or AEs. One participant in FluMist group did not have any RE data and was excluded from the RE analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Had Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-180 days after study vaccination', 'description': 'An SAE is any AE that results in any of the following outcomes: •Death • Life-threatening • Inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity • Congenital anomaly/birth defect (in the offspring of a study participant) • An important medical event that may may jeopardize the study participant and may require medical or surgical intervention to prevent one of the outcomes listed above.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received any study vaccine and had any follow-up for REs and/or AEs.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Had Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-42 days after study vaccination', 'description': 'An AE is any untoward medical occurrence in a patient or clinical investigations study participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received any study vaccine and had any follow-up for REs and/or AEs.'}, {'type': 'PRIMARY', 'title': 'Number of Significant New Medical Conditions (SNMCs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '43-180 days after study vaccination', 'description': 'A significant new medical condition is defined as a new diagnosis of a chronic medical condition that does not meet the criteria of a SAE.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received any study vaccine and had any follow-up for REs and/or AEs.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Shedding Vaccine-like Virus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-5 days after study vaccination', 'description': 'Number of participants with nasal swab samples that contained vaccine-like virus are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received any study vaccine and had any follow-up for REs and/or AEs.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Shedding Vaccine-like Virus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7-10 days after study vaccination', 'description': 'Number of participants with nasal swab samples that contained vaccine-like virus are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received any study vaccine and had any follow-up for REs and/or AEs.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Shedding Vaccine-like Virus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14-28 days after study vaccination', 'description': 'Number of participants with nasal swab samples that contained vaccine-like virus are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received any study vaccine and had any follow-up for REs and/or AEs.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Shedding Vaccine-like Virus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '35-42 days after study vaccination', 'description': 'Number of participants with nasal swab samples that contained vaccine-like virus are reported. Sample was collected at this time point only if health assessment indicated presence of a respiratory illness, including otitis media.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received any study vaccine and had any follow-up for REs and/or AEs.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Shedding Vaccine-like Virus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'participants w/unsched. illness visits', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Unscheduled visits occurring during 0-42 days after study vaccination', 'description': 'Number of participants with nasal swab samples that contained vaccine-like virus are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'participants w/unsched. illness visits', 'denomUnitsSelected': 'participants w/unsched. illness visits', 'populationDescription': 'Participants who received any study vaccine and had any follow-up for REs and/or AEs.'}, {'type': 'SECONDARY', 'title': 'T- and B-lymphocyte Subsets by Flow Cytometry - Cluster of Differentiation (CD) 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '8.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.', 'unitOfMeasure': 'percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '83.6', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '89.1', 'spread': '10.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.', 'unitOfMeasure': 'percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '46.7', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.', 'unitOfMeasure': 'percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '38.8', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.', 'unitOfMeasure': 'percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '8.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.', 'unitOfMeasure': 'percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '82.0', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '89.9', 'spread': '11.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.', 'unitOfMeasure': 'percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '48.2', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '46.5', 'spread': '11.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.', 'unitOfMeasure': 'percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '27.9', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '39.6', 'spread': '10.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.', 'unitOfMeasure': 'percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Interferon (INF)-Gamma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '17.0', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '25.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation spots-forming cells per 10\\^5 T cells is reported.', 'unitOfMeasure': 'cells per 10^5 T cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'INF-Gamma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '43.7', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '7.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation spots-forming cells per 10\\^5 T cells is reported.', 'unitOfMeasure': 'cells per 10^5 T cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'INF-Gamma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'spread': '38.7', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '27.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean and standard deviation spots-forming cells per 10\\^5 T cells is reported.', 'unitOfMeasure': 'cells per 10^5 T cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Interleukin (IL)-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation spots-forming cells per 10\\^5 T cells is reported.', 'unitOfMeasure': 'cells per 10^5 T cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'IL-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation spots-forming cells per 10\\^5 T cells is reported.', 'unitOfMeasure': 'cells per 10^5 T cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'IL-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '6.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean and standard deviation spots-forming cells per 10\\^5 T cells is reported.', 'unitOfMeasure': 'cells per 10^5 T cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Human Leukocyte Antigen (HLA) Matched Tetramers CD8+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.045', 'spread': '6.452', 'groupId': 'OG000'}, {'value': '12.778', 'spread': '6.579', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.', 'unitOfMeasure': 'Percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'HLA Matched Tetramers CD8+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.048', 'spread': '6.701', 'groupId': 'OG000'}, {'value': '8.632', 'spread': '4.126', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7-10 days after study vaccination', 'description': 'The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.', 'unitOfMeasure': 'Percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'HLA Matched Tetramers CD8+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.997', 'spread': '3.143', 'groupId': 'OG000'}, {'value': '12.922', 'spread': '8.607', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '35-42 days after study vaccination', 'description': 'The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.', 'unitOfMeasure': 'Percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H1N1 Hemagglutination Inhibition (HAI) Titers From Baseline to Day 35-42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination', 'description': 'Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers \\>= 4 from baseline are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H3N2 HAI Titers From Baseline to Day 35-42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination', 'description': 'Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers \\>= 4 from baseline are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza B HAI Titers From Baseline to Day 35-42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination', 'description': 'Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers \\>= 4 from baseline are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H1N1 Microneutralization Titers From Baseline to Day 35-42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination', 'description': 'Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers \\>= 4 from baseline are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H3N2 Microneutralization Titers From Baseline to Day 35-42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination', 'description': 'Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers \\>= 4 from baseline are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced a >= 4-fold Rise in Influenza B Microneutralization Titers From Baseline to Day 35-42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination', 'description': 'Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers \\>= 4 from baseline are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H1N1 Immunoglobulin A (IgA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H1N1 IgA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-5 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H1N1 IgA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H1N1 IgA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14-28 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H1N1 IgA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H3N2 IgA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H3N2 IgA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-5 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H3N2 IgA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H3N2 IgA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14-28 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H3N2 IgA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza B IgA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza B IgA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-5 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza B IgA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza B IgA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14-28 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza B IgA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of CD56 lymphocyte subsets is reported.', 'unitOfMeasure': 'percent of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation results of CD56 lymphocyte subsets is reported.', 'unitOfMeasure': 'percent of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.91', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '4.19', 'spread': '1.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of white blood cells subsets is reported.', 'unitOfMeasure': 'cells per 10^3/UL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.05', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '3.24', 'spread': '1.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation results of white blood cells subsets is reported.', 'unitOfMeasure': 'cells per 10^3/UL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '27.56', 'spread': '9.25', 'groupId': 'OG000'}, {'value': '17.62', 'spread': '7.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of lymphocytes subsets is reported.', 'unitOfMeasure': 'Percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '23.13', 'spread': '8.23', 'groupId': 'OG000'}, {'value': '22.58', 'spread': '11.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation results of lymphocytes subsets is reported.', 'unitOfMeasure': 'Percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '0.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of absolute lymphocytes subsets is reported.', 'unitOfMeasure': 'Cells per 10^3/UL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.98', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation results of absolute lymphocytes subsets is reported.', 'unitOfMeasure': 'Cells per 10^3/UL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '2728.6', 'spread': '1162.9', 'groupId': 'OG000'}, {'value': '3300.0', 'spread': '1534.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of absolute neutrophils subsets is reported.', 'unitOfMeasure': 'Cells per 10^3/UL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H1N1 Immunoglobulin G (IgG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '672.4', 'spread': '492.8', 'groupId': 'OG000'}, {'value': '954.7', 'spread': '1245.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgG from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H1N1 IgG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '844.0', 'spread': '645.7', 'groupId': 'OG000'}, {'value': '924.3', 'spread': '1207.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgG from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H3N2 IgG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '1842.4', 'spread': '1989.1', 'groupId': 'OG000'}, {'value': '799.1', 'spread': '426.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgG from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H3N2 IgG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '1671.9', 'spread': '1646.6', 'groupId': 'OG000'}, {'value': '742.9', 'spread': '432.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgG from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza B IgG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '638.6', 'spread': '334.5', 'groupId': 'OG000'}, {'value': '599.1', 'spread': '344.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgG from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza B IgG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '1020.3', 'spread': '715.6', 'groupId': 'OG000'}, {'value': '620.2', 'spread': '472.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgG from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H1N1 Immunoglobulin M (IgM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '160.4', 'spread': '105.4', 'groupId': 'OG000'}, {'value': '150.1', 'spread': '107.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgM from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H1N1 IgM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '134.8', 'spread': '100.7', 'groupId': 'OG000'}, {'value': '171.3', 'spread': '106.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgM from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H3N2 IgM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '134.7', 'spread': '100.4', 'groupId': 'OG000'}, {'value': '153.1', 'spread': '109.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgM from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza A/H3N2 IgM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '136.9', 'spread': '103.1', 'groupId': 'OG000'}, {'value': '189.9', 'spread': '98.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgM from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza B IgM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '72.2', 'spread': '66.7', 'groupId': 'OG000'}, {'value': '69.3', 'spread': '61.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgM from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}, {'type': 'SECONDARY', 'title': 'Influenza B IgM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}], 'classes': [{'categories': [{'measurements': [{'value': '68.4', 'spread': '55.3', 'groupId': 'OG000'}, {'value': '82.0', 'spread': '69.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgM from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}, {'id': 'FG001', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 20 participants, 10 in the FluMist group and 10 in the placebo group, were enrolled in the study between 08Aug2005 and 31Mar2008 at 4 sites in the USA.', 'preAssignmentDetails': 'A total of 20 participants were randomized in a 1:1 ratio to the FluMist or placebo group. Participants were enrolled on a staggered schedule to assess safety. Four participants were enrolled and treated in 2005, 8 in 2006, and 8 in 2007; each subset was assessed for vaccine-related serious adverse events prior to enrollment of the next subset.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).'}, {'id': 'BG001', 'title': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10\\^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '12.2', 'spread': '3.9', 'groupId': 'BG001'}, {'value': '12.2', 'spread': '3.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2008-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-29', 'studyFirstSubmitDate': '2005-05-27', 'resultsFirstSubmitDate': '2012-02-27', 'studyFirstSubmitQcDate': '2005-05-27', 'lastUpdatePostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-07-31', 'studyFirstPostDateStruct': {'date': '2005-05-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Had Reactogenicity Events (REs)', 'timeFrame': '0-42 days after study vaccination', 'description': 'Reactogenicity events (REs) are predefined solicited adverse events (AEs) that can potentially occur after vaccine administration. The REs for this study included fever, runny nose/nasal congestion, sore throat, cough, vomiting, headache, muscle aches, chills, tiredness, and irritability.'}, {'measure': 'Number of Participants Who Had Serious Adverse Events (SAEs)', 'timeFrame': '0-180 days after study vaccination', 'description': 'An SAE is any AE that results in any of the following outcomes: •Death • Life-threatening • Inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity • Congenital anomaly/birth defect (in the offspring of a study participant) • An important medical event that may may jeopardize the study participant and may require medical or surgical intervention to prevent one of the outcomes listed above.'}, {'measure': 'Number of Participants Who Had Adverse Events (AEs)', 'timeFrame': '0-42 days after study vaccination', 'description': 'An AE is any untoward medical occurrence in a patient or clinical investigations study participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.'}, {'measure': 'Number of Significant New Medical Conditions (SNMCs)', 'timeFrame': '43-180 days after study vaccination', 'description': 'A significant new medical condition is defined as a new diagnosis of a chronic medical condition that does not meet the criteria of a SAE.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Shedding Vaccine-like Virus', 'timeFrame': '3-5 days after study vaccination', 'description': 'Number of participants with nasal swab samples that contained vaccine-like virus are reported.'}, {'measure': 'Number of Participants Shedding Vaccine-like Virus', 'timeFrame': '7-10 days after study vaccination', 'description': 'Number of participants with nasal swab samples that contained vaccine-like virus are reported.'}, {'measure': 'Number of Participants Shedding Vaccine-like Virus', 'timeFrame': '14-28 days after study vaccination', 'description': 'Number of participants with nasal swab samples that contained vaccine-like virus are reported.'}, {'measure': 'Number of Participants Shedding Vaccine-like Virus', 'timeFrame': '35-42 days after study vaccination', 'description': 'Number of participants with nasal swab samples that contained vaccine-like virus are reported. Sample was collected at this time point only if health assessment indicated presence of a respiratory illness, including otitis media.'}, {'measure': 'Number of Participants Shedding Vaccine-like Virus', 'timeFrame': 'Unscheduled visits occurring during 0-42 days after study vaccination', 'description': 'Number of participants with nasal swab samples that contained vaccine-like virus are reported.'}, {'measure': 'T- and B-lymphocyte Subsets by Flow Cytometry - Cluster of Differentiation (CD) 19', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.'}, {'measure': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD3', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.'}, {'measure': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD4', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.'}, {'measure': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD8', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.'}, {'measure': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD19', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.'}, {'measure': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD3', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.'}, {'measure': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD4', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.'}, {'measure': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD8', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.'}, {'measure': 'Interferon (INF)-Gamma', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation spots-forming cells per 10\\^5 T cells is reported.'}, {'measure': 'INF-Gamma', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation spots-forming cells per 10\\^5 T cells is reported.'}, {'measure': 'INF-Gamma', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean and standard deviation spots-forming cells per 10\\^5 T cells is reported.'}, {'measure': 'Interleukin (IL)-4', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation spots-forming cells per 10\\^5 T cells is reported.'}, {'measure': 'IL-4', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation spots-forming cells per 10\\^5 T cells is reported.'}, {'measure': 'IL-4', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean and standard deviation spots-forming cells per 10\\^5 T cells is reported.'}, {'measure': 'Human Leukocyte Antigen (HLA) Matched Tetramers CD8+', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.'}, {'measure': 'HLA Matched Tetramers CD8+', 'timeFrame': '7-10 days after study vaccination', 'description': 'The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.'}, {'measure': 'HLA Matched Tetramers CD8+', 'timeFrame': '35-42 days after study vaccination', 'description': 'The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.'}, {'measure': 'Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H1N1 Hemagglutination Inhibition (HAI) Titers From Baseline to Day 35-42', 'timeFrame': 'Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination', 'description': 'Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers \\>= 4 from baseline are reported.'}, {'measure': 'Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H3N2 HAI Titers From Baseline to Day 35-42', 'timeFrame': 'Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination', 'description': 'Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers \\>= 4 from baseline are reported.'}, {'measure': 'Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza B HAI Titers From Baseline to Day 35-42', 'timeFrame': 'Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination', 'description': 'Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers \\>= 4 from baseline are reported.'}, {'measure': 'Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H1N1 Microneutralization Titers From Baseline to Day 35-42', 'timeFrame': 'Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination', 'description': 'Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers \\>= 4 from baseline are reported.'}, {'measure': 'Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H3N2 Microneutralization Titers From Baseline to Day 35-42', 'timeFrame': 'Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination', 'description': 'Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers \\>= 4 from baseline are reported.'}, {'measure': 'Number of Participants Who Experienced a >= 4-fold Rise in Influenza B Microneutralization Titers From Baseline to Day 35-42', 'timeFrame': 'Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination', 'description': 'Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers \\>= 4 from baseline are reported.'}, {'measure': 'Influenza A/H1N1 Immunoglobulin A (IgA)', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza A/H1N1 IgA', 'timeFrame': '3-5 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza A/H1N1 IgA', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza A/H1N1 IgA', 'timeFrame': '14-28 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza A/H1N1 IgA', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza A/H3N2 IgA', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza A/H3N2 IgA', 'timeFrame': '3-5 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza A/H3N2 IgA', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza A/H3N2 IgA', 'timeFrame': '14-28 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza A/H3N2 IgA', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza B IgA', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza B IgA', 'timeFrame': '3-5 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza B IgA', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza B IgA', 'timeFrame': '14-28 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza B IgA', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgA from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD56', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of CD56 lymphocyte subsets is reported.'}, {'measure': 'T- and B-lymphocyte Subsets by Flow Cytometry - CD56', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation results of CD56 lymphocyte subsets is reported.'}, {'measure': 'T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of white blood cells subsets is reported.'}, {'measure': 'T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation results of white blood cells subsets is reported.'}, {'measure': 'T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of lymphocytes subsets is reported.'}, {'measure': 'T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation results of lymphocytes subsets is reported.'}, {'measure': 'T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of absolute lymphocytes subsets is reported.'}, {'measure': 'T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes', 'timeFrame': '7-10 days after study vaccination', 'description': 'Mean and standard deviation results of absolute lymphocytes subsets is reported.'}, {'measure': 'T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Neutrophils', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean and standard deviation results of absolute neutrophils subsets is reported.'}, {'measure': 'Influenza A/H1N1 Immunoglobulin G (IgG)', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgG from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza A/H1N1 IgG', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgG from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza A/H3N2 IgG', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgG from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza A/H3N2 IgG', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgG from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza B IgG', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgG from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza B IgG', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgG from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza A/H1N1 Immunoglobulin M (IgM)', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgM from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza A/H1N1 IgM', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgM from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza A/H3N2 IgM', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgM from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza A/H3N2 IgM', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgM from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza B IgM', 'timeFrame': 'pre-dosing (Day 0)', 'description': 'Mean of influenza-specific IgM from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}, {'measure': 'Influenza B IgM', 'timeFrame': '35-42 days after study vaccination', 'description': 'Mean of influenza-specific IgM from nasal swab is reported. Titers of \\< 1 were assigned the value of 0.5.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer, pediatric, influenza, vaccine'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '21496468', 'type': 'RESULT', 'citation': 'Halasa N, Englund JA, Nachman S, Weinberg GA, Huber VC, Allison K, Dubovsky F, Yi T, McCullers JA, Flynn PM. Safety of live attenuated influenza vaccine in mild to moderately immunocompromised children with cancer. Vaccine. 2011 May 31;29(24):4110-5. doi: 10.1016/j.vaccine.2011.03.097. Epub 2011 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to get information about the safety of a flu vaccine spray, called FluMist, in children with cancer. The study is also being done to find out how much and how long the vaccine spray can be found in the nose.', 'detailedDescription': 'This study is a randomized, double-blind Phase 1 study of FluMist vs. placebo in mild to moderately immunocompromised children 5 to 17 years of age with cancer. The primary objective of this study is to describe the safety of FluMist compared with placebo in mild to moderately immunocompromised children with cancer. The secondary objectives of this study are to describe the immune responses following vaccination with FluMist and to determine the incidence and duration of viral replication following vaccination with FluMist.\n\nThe standard 0.5 mL dose of vaccine or placebo was administered intranasally. Patients were evaluated at four visits scheduled between days 3-5, days 7-10, days 14-28, and days 35-42 for viral shedding via nasal swabs. Safety outcomes were collected at study clinic visits or by telephone contact through 42 days post dose. Serious adverse events and significant new medical conditions were collected through 180 days after receipt of investigational product.\n\nImmune responses were measured by detection of influenza-specific antibodies as measured by the standard hemagglutination inhibition (HAI) assay. Influenza-specific serum antibody isotype levels were determined and nasal swab specimens were analyzed for the expression of influenza-specific immunoglobulin A (IgA). Serum was analyzed for its ability to neutralize viral particles from infecting Madin-Darby canine kidney cells (microneutralization). Baseline immunosuppression as measured by expression of T- and B-lymphocyte subsets was compared to immunosuppression at time points after vaccination. The duration of viral replication and the titers of live-attenuated influenza virus shed was evaluated from nasal swab specimens collected at scheduled time points after administration of FluMist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 5 through 17 years of age (not yet reached their 18th birthday) at the time of entry into the study;\n* Patient's parent or legal guardian available by telephone during the course of the study;\n* Written informed consent (assent if applicable) and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the patient's parent or legal guardian;\n* Ability of the patient or patient's parent/guardian to comply with the requirements of the protocol;\n* Currently receiving chemotherapy and/or radiation therapy for the treatment of cancer or have received chemotherapy in the past 12 weeks;\n* If the subject's underlying cancer is a solid tumor, current status must be stable disease, partial response, or complete response to therapy; if the subject's underlying disease is a hematologic malignancy, current status must be in remission;\n* Estimated life expectancy of \\>1 year; and\n* Currently has no worse than mild to moderate immunosuppression (meets none of the exclusion criteria).\n\nExclusion Criteria:\n\n* History of hypersensitivity to any component of FluMist, including egg or egg products, or monosodium glutamate;\n* History of hypersensitivity to gentamicin;\n* Close contact with a severely immunocompromised patient (e.g., a hematopoietic stem cell transplant patient, during those periods in which the immunocompromised patient requires care in a protective environment);\n* History of Guillain-Barré syndrome;\n* History of asthma;\n* Use of aspirin or salicylate-containing products in the 30 days prior to study vaccination or expected receipt within the study duration;\n* Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to enrollment or expected receipt (unless medically indicated) during this study;\n* Currently receiving inhaled steroid therapy;\n* Receipt of immunoglobulin within the past 90 days;\n* Receipt of stem cell transplant;\n* Acute febrile \\[\\>100.0°F (37.8°C) oral\\] illness or acute respiratory illness, e.g., cough or sore throat, within three days prior to enrollment;\n* Administration of any live vaccine within 30 days prior to enrollment or if receipt of another live vaccine is expected within 30 days after the vaccination in this study;\n* Administration of any inactivated vaccine within two weeks prior to enrollment or if receipt of another inactivated vaccine is expected within two weeks after the vaccination in this study;\n* Receipt of an investigational product studied under an investigational new drug (IND) within 10 days prior to study entry or expected receipt of such an investigational product within 10 days after study vaccination (Note: an investigational product not studied under an IND is allowed at the investigator's discretion);\n* Pregnancy or, in biologically capable females (e.g., menses within the last year), not willing to agree to acceptable birth control for three months after study vaccination (for those biologically capable, a urine pregnancy test must be performed on the day of vaccination with a negative result);\n* Female who is breastfeeding or lactating;\n* Any condition or receipt of other medication that, in the opinion of the investigator, might interfere with the evaluation of the vaccine or interpretation of study results;\n* At the study screening visit (within 16 days before study vaccination) a CD4+ T cell percentage of \\<15%;\n* At study entry, an absolute neutrophil count less than or equal to 500 cells/mm3;\n* Receipt of high-dose systemic corticosteroids (≥ 2 mg/kg total of prednisone or equivalent given daily or on alternating days) for ≥ 14 consecutive days within 30 days prior to or following study vaccination"}, 'identificationModule': {'nctId': 'NCT00112112', 'briefTitle': 'Safety Study to Evaluate FluMist in Immunocompromised Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase I Randomized, Double-Blind Trial of the Safety and Immunogenicity of FluMist® A Live, Intranasal Influenza Virus Vaccine vs. Placebo in Immunocompromised Children Ages 5 Through 17 Years of Age', 'orgStudyIdInfo': {'id': 'MI-CP114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FluMist', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains. During the 2005 enrollment period, the three 2004/2005 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/Wyoming/03/2003(H3N2), and B/Jilin/20/2003). During the 2006 and 2007 enrollment periods, the three 2005/2006 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/California/7/2004(H3N2), and B/Jiangsu/10/2003 (B/Shanghai/361/2002-like.', 'interventionNames': ['Biological: FluMist']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'FluMist', 'type': 'BIOLOGICAL', 'description': 'The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains. During the 2005 enrollment period, the three 2004/2005 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/Wyoming/03/2003(H3N2), and B/Jilin/20/2003). During the 2006 and 2007 enrollment periods, the three 2005/2006 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/California/7/2004(H3N2), and B/Jiangsu/10/2003 (B/Shanghai/361/2002-like.\n\nbrief description of the arm. This element may not be necessary if the associated intervention descriptions contain sufficient information to describe the arm.', 'armGroupLabels': ['FluMist']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester School of Medicine & Dentistry', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University Medical Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude's Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Children's Hospital Regional Medical Center", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Raburn Mallory, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}