Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-02-20 @ 10:10 PM
Study NCT ID:
NCT02649192
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2016-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D007252', 'term': 'Influenza Vaccines'}, {'id': 'C007792', 'term': 'Fumigant 93'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D008508', 'term': 'Medication Errors'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019300', 'term': 'Medical Errors'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@stjude.org', 'phone': '866-278-5833', 'title': 'Nehali Patel, MD', 'organization': "St. Jude Children's Research Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '56 days after the final participant was dosed on Day 0.', 'eventGroups': [{'id': 'EG000', 'title': 'A&D-S1', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo - S1', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'A&D - S2', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 6, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo - S2', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 6, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'A&D - S3', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo - S3', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 3, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Facial trauma/fractured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left forearm bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Positive Responses in Virus-specific Antibody in Sera', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'A&D - S1', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season'}, {'id': 'OG001', 'title': 'Placebo - S1', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season'}, {'id': 'OG002', 'title': 'A&D - S2', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season'}, {'id': 'OG003', 'title': 'Placebo - S2', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season'}, {'id': 'OG004', 'title': 'A&D - S3', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season'}, {'id': 'OG005', 'title': 'Placebo - S3', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '100', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 56 after vaccination', 'description': 'The percentage of 2X increases or conversion from undetectable to detectable response in virus-specific antibody toward any vaccine component after 2 immunizations in intervention and control groups will be reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "All enrolled subjects who satisfied the inclusion/exclusion criteria were included in the analysis. For the four participants who didn't complete the study, results after one immunization were used."}, {'type': 'PRIMARY', 'title': 'Isotype Ratios on Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'A&D-S1', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season'}, {'id': 'OG001', 'title': 'Placebo - S1', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season'}, {'id': 'OG002', 'title': 'A&D - S2', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season'}, {'id': 'OG003', 'title': 'Placebo - S2', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season'}, {'id': 'OG004', 'title': 'A&D - S3', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season'}, {'id': 'OG005', 'title': 'Placebo - S3', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season'}], 'classes': [{'title': 'IgA/IgG1', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.67'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.22', 'upperLimit': '0.5'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.004', 'upperLimit': '0.63'}, {'value': '0.27', 'groupId': 'OG003', 'lowerLimit': '0.13', 'upperLimit': '0.47'}, {'value': '0.21', 'groupId': 'OG004', 'lowerLimit': '0.13', 'upperLimit': '0.65'}, {'value': '0.28', 'groupId': 'OG005', 'lowerLimit': '0.12', 'upperLimit': '0.87'}]}]}, {'title': 'IgA/IgG2', 'categories': [{'measurements': [{'value': '0.71', 'groupId': 'OG000', 'lowerLimit': '0.24', 'upperLimit': '0.85'}, {'value': '0.69', 'groupId': 'OG001', 'lowerLimit': '0.49', 'upperLimit': '1.93'}, {'value': '0.96', 'groupId': 'OG002', 'lowerLimit': '0.004', 'upperLimit': '6.3'}, {'value': '1.13', 'groupId': 'OG003', 'lowerLimit': '0.58', 'upperLimit': '4.45'}, {'value': '0.65', 'groupId': 'OG004', 'lowerLimit': '0.19', 'upperLimit': '2.03'}, {'value': '0.75', 'groupId': 'OG005', 'lowerLimit': '0.22', 'upperLimit': '2.39'}]}]}, {'title': 'IgA/IgG3', 'categories': [{'measurements': [{'value': '2.73', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '7.75'}, {'value': '3.03', 'groupId': 'OG001', 'lowerLimit': '1.55', 'upperLimit': '7.44'}, {'value': '1.44', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '6.97'}, {'value': '1.68', 'groupId': 'OG003', 'lowerLimit': '0.29', 'upperLimit': '5.13'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '0.89', 'upperLimit': '12.5'}, {'value': '3.02', 'groupId': 'OG005', 'lowerLimit': '0.41', 'upperLimit': '12.3'}]}]}, {'title': 'IgA/IgM', 'categories': [{'measurements': [{'value': '2.48', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '2.8'}, {'value': '1.37', 'groupId': 'OG001', 'lowerLimit': '0.83', 'upperLimit': '2.89'}, {'value': '1.21', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '3.06'}, {'value': '1.21', 'groupId': 'OG003', 'lowerLimit': '0.45', 'upperLimit': '2.88'}, {'value': '0.86', 'groupId': 'OG004', 'lowerLimit': '0.23', 'upperLimit': '1.9'}, {'value': '1', 'groupId': 'OG005', 'lowerLimit': '0.14', 'upperLimit': '3.26'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2015-16 season', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.49', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2016-17 season', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.50', 'groupIds': ['OG004', 'OG005'], 'groupDescription': 'Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2017-18 season', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2015-16 season', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.76', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2016-17 season', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.65', 'groupIds': ['OG004', 'OG005'], 'groupDescription': 'Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2017-18 season', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2015-16 season', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.76', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2016-17 season', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.54', 'groupIds': ['OG004', 'OG005'], 'groupDescription': 'Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2017-18 season', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2015-16 season', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.95', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2016-17 season', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.34', 'groupIds': ['OG004', 'OG005'], 'groupDescription': 'Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2017-18 season', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 56 after vaccination', 'description': 'Isotype ratios will be summarized with descriptive statistics.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with complete isotype data at day 56. Subjects with an undetermined assay result were not included in analyses. In some cases, the limit of detection (LOD) for the assay was reached and that LOD value was used in calculations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seroconversion at Day 56 After Vaccination, Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'A&D-S1', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season'}, {'id': 'OG001', 'title': 'Placebo - S1', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season'}, {'id': 'OG002', 'title': 'A&D - S2', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season'}, {'id': 'OG003', 'title': 'Placebo - S2', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season'}, {'id': 'OG004', 'title': 'A&D - S3', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season'}, {'id': 'OG005', 'title': 'Placebo - S3', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season'}], 'classes': [{'title': 'H1N1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '71.4', 'groupId': 'OG002', 'lowerLimit': '47.8', 'upperLimit': '88.7'}, {'value': '95.0', 'groupId': 'OG003', 'lowerLimit': '75.1', 'upperLimit': '99.9'}, {'value': '72.7', 'groupId': 'OG004', 'lowerLimit': '39.0', 'upperLimit': '94.0'}, {'value': '85.7', 'groupId': 'OG005', 'lowerLimit': '57.2', 'upperLimit': '98.2'}]}]}, {'title': 'H3N2', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '85.3'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '71.4', 'groupId': 'OG002', 'lowerLimit': '47.8', 'upperLimit': '88.7'}, {'value': '80.0', 'groupId': 'OG003', 'lowerLimit': '56.3', 'upperLimit': '94.3'}, {'value': '72.7', 'groupId': 'OG004', 'lowerLimit': '39.0', 'upperLimit': '94.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '23.0', 'upperLimit': '77.0'}]}]}, {'title': 'B/Phuket', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '28.6', 'groupId': 'OG002', 'lowerLimit': '11.3', 'upperLimit': '52.2'}, {'value': '55.0', 'groupId': 'OG003', 'lowerLimit': '31.5', 'upperLimit': '76.9'}, {'value': '45.5', 'groupId': 'OG004', 'lowerLimit': '16.7', 'upperLimit': '76.6'}, {'value': '28.6', 'groupId': 'OG005', 'lowerLimit': '8.4', 'upperLimit': '58.1'}]}]}, {'title': 'B/Brisbane', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '28.6', 'groupId': 'OG002', 'lowerLimit': '11.3', 'upperLimit': '52.2'}, {'value': '55.0', 'groupId': 'OG003', 'lowerLimit': '31.5', 'upperLimit': '76.9'}, {'value': '27.3', 'groupId': 'OG004', 'lowerLimit': '6.0', 'upperLimit': '61.0'}, {'value': '35.7', 'groupId': 'OG005', 'lowerLimit': '12.8', 'upperLimit': '64.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference in Seroconversion R', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '0', 'estimateComment': 'Treatment group minus placebo', 'groupDescription': 'H1N1', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Treatment Difference in Seroconversion R', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.6', 'ciLowerLimit': '-51.7', 'ciUpperLimit': '6.2', 'estimateComment': 'Treatment group minus placebo', 'groupDescription': 'H1N1', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Treatment Difference in Seroconversion R', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.0', 'ciLowerLimit': '-49.4', 'ciUpperLimit': '26.5', 'estimateComment': 'Treatment group minus placebo', 'groupDescription': 'H1N1', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference in Seroconversion R', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.0', 'ciLowerLimit': '-70.1', 'ciUpperLimit': '56.1', 'estimateComment': 'Treatment group minus placebo', 'groupDescription': 'H3N2', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Treatment Difference in Seroconversion R', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.6', 'ciLowerLimit': '-38.8', 'ciUpperLimit': '20.6', 'estimateComment': 'Treatment group minus placebo', 'groupDescription': 'H3N2', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Treatment Difference in Seroconversion R', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.7', 'ciLowerLimit': '-17.5', 'ciUpperLimit': '57.9', 'estimateComment': 'Treatment group minus placebo', 'groupDescription': 'H3N2', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference in Seroconversion R', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '0', 'estimateComment': 'Treatment group minus placebo', 'groupDescription': 'B/Phuket', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Treatment Difference in Seroconversion R', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.4', 'ciLowerLimit': '-54.1', 'ciUpperLimit': '5.8', 'estimateComment': 'Treatment group minus placebo', 'groupDescription': 'B/Phuket', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Treatment Difference in Seroconversion R', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.9', 'ciLowerLimit': '-23.1', 'ciUpperLimit': '53.3', 'estimateComment': 'Treatment group minus placebo', 'groupDescription': 'B/Phuket', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference in Seroconversion R', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '0', 'estimateComment': 'Treatment group minus placebo', 'groupDescription': 'B/Brisbane', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Treatment Difference in Seroconversion R', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.4', 'ciLowerLimit': '-54.1', 'ciUpperLimit': '5.8', 'estimateComment': 'Treatment group minus placebo', 'groupDescription': 'B/Brisbane', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Treatment Difference in Seroconversion R', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.4', 'ciLowerLimit': '-45.4', 'ciUpperLimit': '30.5', 'estimateComment': 'Treatment group minus placebo', 'groupDescription': 'B/Brisbane', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 56 after vaccination', 'description': 'Secondary analyses will examine sero-conversion based on antibody functions (HAI or neutralization) defined as antibody titers of \\<1:40 converting to ≥1:40, or a four-fold increase in titer for participants with a starting titer of ≥1:40. Sero-conversion rate (expressed as percentage) will be estimated with 95% confidence interval. The rate difference will be described with point estimate and 95% confidence interval.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with complete HAI data at day 56. Subjects without a day 56 sample were not included in analyses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seroconversion at Day 56 After Vaccination, by Vitamin A Levels at Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'A&D-S1 VAS', 'description': 'Sub-group of subjects from the A\\&D-S1 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2015-16 season'}, {'id': 'OG001', 'title': 'Placebo-S1 VAS', 'description': 'Sub-group of subjects from the Placebo-S1 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus matched placebo in 2015-16 season'}, {'id': 'OG002', 'title': 'A&D-S2 VAS', 'description': 'Sub-group of subjects from the A\\&D-S2 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2016-17 season'}, {'id': 'OG003', 'title': 'Placebo-S2 VAS', 'description': 'Sub-group of subjects from the Placebo-S2 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus matched placebo in 2016-17 season'}, {'id': 'OG004', 'title': 'A&D-S3 VAS', 'description': 'Sub-group of subjects from the A\\&D-S3 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2017-18 season'}, {'id': 'OG005', 'title': 'Placebo-S3 VAS', 'description': 'Sub-group of subjects from the Placebo-S3 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus matched placebo in 2017-18 season'}, {'id': 'OG006', 'title': 'A&D-S1 Non-VAS', 'description': 'Sub-group of subjects from the A\\&D-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2015-16 season'}, {'id': 'OG007', 'title': 'Placebo-S1 Non-VAS', 'description': 'Sub-group of subjects from the Placebo-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2015-16 season'}, {'id': 'OG008', 'title': 'A&D-S2 Non-VAS', 'description': 'Sub-group of subjects from the A\\&D-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2016-17 season'}, {'id': 'OG009', 'title': 'Placebo-S2 Non-VAS', 'description': 'Sub-group of subjects from the Placebo-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2016-17 season'}, {'id': 'OG010', 'title': 'A&D-S3 Non-VAS', 'description': 'Sub-group of subjects from the A\\&D-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2017-18 season'}, {'id': 'OG011', 'title': 'Placebo-S3 Non-VAS', 'description': 'Sub-group of subjects from the Placebo-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2017-18 season'}], 'classes': [{'title': 'H1N1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '81.8', 'groupId': 'OG002', 'lowerLimit': '48.2', 'upperLimit': '97.7'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '71.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '59.0', 'upperLimit': '100'}, {'value': '87.5', 'groupId': 'OG005', 'lowerLimit': '47.3', 'upperLimit': '99.7'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG007', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '60.0', 'groupId': 'OG008', 'lowerLimit': '26.2', 'upperLimit': '87.8'}, {'value': '88.9', 'groupId': 'OG009', 'lowerLimit': '51.8', 'upperLimit': '99.7'}, {'value': '25.0', 'groupId': 'OG010', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '83.3', 'groupId': 'OG011', 'lowerLimit': '35.9', 'upperLimit': '99.6'}]}]}, {'title': 'H3N2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '84.2'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '15.8', 'upperLimit': '100'}, {'value': '72.7', 'groupId': 'OG002', 'lowerLimit': '39.0', 'upperLimit': '94.0'}, {'value': '90.9', 'groupId': 'OG003', 'lowerLimit': '58.7', 'upperLimit': '99.8'}, {'value': '71.4', 'groupId': 'OG004', 'lowerLimit': '29.0', 'upperLimit': '96.3'}, {'value': '37.5', 'groupId': 'OG005', 'lowerLimit': '8.5', 'upperLimit': '75.5'}, {'value': '66.7', 'groupId': 'OG006', 'lowerLimit': '9.4', 'upperLimit': '99.2'}, {'value': '0', 'groupId': 'OG007', 'lowerLimit': '0', 'upperLimit': '84.2'}, {'value': '70.0', 'groupId': 'OG008', 'lowerLimit': '34.8', 'upperLimit': '93.3'}, {'value': '66.7', 'groupId': 'OG009', 'lowerLimit': '29.9', 'upperLimit': '92.5'}, {'value': '75.0', 'groupId': 'OG010', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '66.7', 'groupId': 'OG011', 'lowerLimit': '22.3', 'upperLimit': '95.7'}]}]}, {'title': 'B/Phuket', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '45.5', 'groupId': 'OG002', 'lowerLimit': '16.7', 'upperLimit': '76.6'}, {'value': '72.7', 'groupId': 'OG003', 'lowerLimit': '39.0', 'upperLimit': '94.0'}, {'value': '42.9', 'groupId': 'OG004', 'lowerLimit': '9.9', 'upperLimit': '81.6'}, {'value': '25.0', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '65.1'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG007', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '10.0', 'groupId': 'OG008', 'lowerLimit': '0.3', 'upperLimit': '44.5'}, {'value': '33.3', 'groupId': 'OG009', 'lowerLimit': '7.5', 'upperLimit': '70.1'}, {'value': '50.0', 'groupId': 'OG010', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '33.3', 'groupId': 'OG011', 'lowerLimit': '4.3', 'upperLimit': '77.7'}]}]}, {'title': 'B/Brisbane', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '36.4', 'groupId': 'OG002', 'lowerLimit': '10.9', 'upperLimit': '69.2'}, {'value': '63.6', 'groupId': 'OG003', 'lowerLimit': '30.8', 'upperLimit': '89.1'}, {'value': '42.9', 'groupId': 'OG004', 'lowerLimit': '9.9', 'upperLimit': '81.6'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '15.7', 'upperLimit': '84.3'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG007', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '20.0', 'groupId': 'OG008', 'lowerLimit': '2.5', 'upperLimit': '55.6'}, {'value': '44.4', 'groupId': 'OG009', 'lowerLimit': '13.7', 'upperLimit': '78.8'}, {'value': '0.0', 'groupId': 'OG010', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '16.7', 'groupId': 'OG011', 'lowerLimit': '0.4', 'upperLimit': '64.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 56 after vaccination', 'description': 'Secondary analyses will examine sero-conversion based on antibody functions (HAI or neutralization) defined as antibody titers of \\<1:40 converting to ≥1:40, or a four-fold increase in titer for participants with a starting titer of ≥1:40. Sero-conversion rate (expressed as percentage) will be estimated with 95% confidence interval for participants sufficient and insufficient in vitamin A at screening.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with complete HAI data at day 56. Subjects without a day 56 sample were not included in analyses.'}, {'type': 'SECONDARY', 'title': 'HAI Titers at Day 56 After Vaccination, Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'A&D-S1', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season'}, {'id': 'OG001', 'title': 'Placebo - S1', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season'}, {'id': 'OG002', 'title': 'A&D - S2', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season'}, {'id': 'OG003', 'title': 'Placebo - S2', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season'}, {'id': 'OG004', 'title': 'A&D - S3', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season'}, {'id': 'OG005', 'title': 'Placebo - S3', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season'}], 'classes': [{'title': 'H1N1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '320'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '640', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '2560'}, {'value': '640', 'groupId': 'OG003', 'lowerLimit': '160', 'upperLimit': '2560'}, {'value': '905', 'groupId': 'OG004', 'lowerLimit': '40', 'upperLimit': '5120'}, {'value': '1280', 'groupId': 'OG005', 'lowerLimit': '80', 'upperLimit': '10240'}]}]}, {'title': 'H3N2', 'categories': [{'measurements': [{'value': '320', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '1280'}, {'value': '480', 'groupId': 'OG001', 'lowerLimit': '160', 'upperLimit': '1280'}, {'value': '1810', 'groupId': 'OG002', 'lowerLimit': '40', 'upperLimit': '20480'}, {'value': '1093', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '5120'}, {'value': '640', 'groupId': 'OG004', 'lowerLimit': '80', 'upperLimit': '2560'}, {'value': '960', 'groupId': 'OG005', 'lowerLimit': '5', 'upperLimit': '5120'}]}]}, {'title': 'B/Phuket', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '80'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '160'}, {'value': '40', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '320'}, {'value': '5', 'groupId': 'OG004', 'lowerLimit': '5', 'upperLimit': '113.14'}, {'value': '5', 'groupId': 'OG005', 'lowerLimit': '5', 'upperLimit': '160'}]}]}, {'title': 'B/Brisbane', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '2560'}, {'value': '40', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '320'}, {'value': '5', 'groupId': 'OG004', 'lowerLimit': '5', 'upperLimit': '452.55'}, {'value': '42.5', 'groupId': 'OG005', 'lowerLimit': '5', 'upperLimit': '640'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 56 after vaccination', 'unitOfMeasure': 'titers', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with complete HAI data at day 56. Subjects without a day 56 sample were not included in analyses.'}, {'type': 'SECONDARY', 'title': 'HAI Titers at Day 56 After Vaccination, by Vitamin A Levels at Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'A&D-S1 VAS', 'description': 'Sub-group of subjects from the A\\&D-S1 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2015-16 season'}, {'id': 'OG001', 'title': 'Placebo-S1 VAS', 'description': 'Sub-group of subjects from the Placebo-S1 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus matched placebo in 2015-16 season'}, {'id': 'OG002', 'title': 'A&D-S2 VAS', 'description': 'Sub-group of subjects from the A\\&D-S2 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2016-17 season'}, {'id': 'OG003', 'title': 'Placebo-S2 VAS', 'description': 'Sub-group of subjects from the Placebo-S2 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus matched placebo in 2016-17 season'}, {'id': 'OG004', 'title': 'A&D-S3 VAS', 'description': 'Sub-group of subjects from the A\\&D-S3 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2017-18 season'}, {'id': 'OG005', 'title': 'Placebo-S3 VAS', 'description': 'Sub-group of subjects from the Placebo-S3 group, vitamin A sufficient (VAS), who received influenza virus vaccine plus matched placebo in 2017-18 season'}, {'id': 'OG006', 'title': 'A&D-S1 Non-VAS', 'description': 'Sub-group of subjects from the A\\&D-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2015-16 season'}, {'id': 'OG007', 'title': 'Placebo-S1 Non-VAS', 'description': 'Sub-group of subjects from the Placebo-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2015-16 season'}, {'id': 'OG008', 'title': 'A&D-S2 Non-VAS', 'description': 'Sub-group of subjects from the A\\&D-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2016-17 season'}, {'id': 'OG009', 'title': 'Placebo-S2 Non-VAS', 'description': 'Sub-group of subjects from the Placebo-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2016-17 season'}, {'id': 'OG010', 'title': 'A&D-S3 Non-VAS', 'description': 'Sub-group of subjects from the A\\&D-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2017-18 season'}, {'id': 'OG011', 'title': 'Placebo-S3 Non-VAS', 'description': 'Sub-group of subjects from the Placebo-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2017-18 season'}], 'classes': [{'title': 'H1N1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '640', 'groupId': 'OG002', 'lowerLimit': '80', 'upperLimit': '1280'}, {'value': '640', 'groupId': 'OG003', 'lowerLimit': '160', 'upperLimit': '2560'}, {'value': '1280', 'groupId': 'OG004', 'lowerLimit': '40', 'upperLimit': '5120'}, {'value': '640', 'groupId': 'OG005', 'lowerLimit': '80', 'upperLimit': '10240'}, {'value': '5', 'groupId': 'OG006', 'lowerLimit': '5', 'upperLimit': '320'}, {'value': '5', 'groupId': 'OG007', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '640', 'groupId': 'OG008', 'lowerLimit': '5', 'upperLimit': '2560'}, {'value': '640', 'groupId': 'OG009', 'lowerLimit': '160', 'upperLimit': '2560'}, {'value': '640', 'groupId': 'OG010', 'lowerLimit': '640', 'upperLimit': '3620.4'}, {'value': '1920', 'groupId': 'OG011', 'lowerLimit': '1280', 'upperLimit': '2560'}]}]}, {'title': 'H3N2', 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '320'}, {'value': '720', 'groupId': 'OG001', 'lowerLimit': '160', 'upperLimit': '1280'}, {'value': '1810', 'groupId': 'OG002', 'lowerLimit': '160', 'upperLimit': '20480'}, {'value': '1280', 'groupId': 'OG003', 'lowerLimit': '160', 'upperLimit': '5120'}, {'value': '2560', 'groupId': 'OG004', 'lowerLimit': '160', 'upperLimit': '2560'}, {'value': '320', 'groupId': 'OG005', 'lowerLimit': '5', 'upperLimit': '3620.4'}, {'value': '320', 'groupId': 'OG006', 'lowerLimit': '5', 'upperLimit': '1280'}, {'value': '480', 'groupId': 'OG007', 'lowerLimit': '320', 'upperLimit': '640'}, {'value': '1545', 'groupId': 'OG008', 'lowerLimit': '40', 'upperLimit': '2560'}, {'value': '640', 'groupId': 'OG009', 'lowerLimit': '5', 'upperLimit': '2560'}, {'value': '400', 'groupId': 'OG010', 'lowerLimit': '80', 'upperLimit': '1280'}, {'value': '1920', 'groupId': 'OG011', 'lowerLimit': '640', 'upperLimit': '5120'}]}]}, {'title': 'B/Phuket', 'categories': [{'measurements': [{'value': '42.5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '80'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '80'}, {'value': '80', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '320'}, {'value': '5', 'groupId': 'OG004', 'lowerLimit': '5', 'upperLimit': '113.14'}, {'value': '5', 'groupId': 'OG005', 'lowerLimit': '5', 'upperLimit': '160'}, {'value': '5', 'groupId': 'OG006', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG007', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG008', 'lowerLimit': '5', 'upperLimit': '160'}, {'value': '5', 'groupId': 'OG009', 'lowerLimit': '5', 'upperLimit': '80'}, {'value': '42.5', 'groupId': 'OG010', 'lowerLimit': '5', 'upperLimit': '80'}, {'value': '42.5', 'groupId': 'OG011', 'lowerLimit': '5', 'upperLimit': '160'}]}]}, {'title': 'B/Brisbane', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '640'}, {'value': '40', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '320'}, {'value': '80', 'groupId': 'OG004', 'lowerLimit': '5', 'upperLimit': '452.55'}, {'value': '80', 'groupId': 'OG005', 'lowerLimit': '5', 'upperLimit': '640'}, {'value': '5', 'groupId': 'OG006', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG007', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG008', 'lowerLimit': '5', 'upperLimit': '2560'}, {'value': '5', 'groupId': 'OG009', 'lowerLimit': '5', 'upperLimit': '320'}, {'value': '5', 'groupId': 'OG010', 'lowerLimit': '5', 'upperLimit': '226.27'}, {'value': '5', 'groupId': 'OG011', 'lowerLimit': '5', 'upperLimit': '320'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 56 after vaccination', 'unitOfMeasure': 'titers', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with complete HAI data at day 56. Subjects without a day 56 sample were not included in analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'A&D - S1', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season'}, {'id': 'FG001', 'title': 'Placebo - S1', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season'}, {'id': 'FG002', 'title': 'A&D - S2', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season'}, {'id': 'FG003', 'title': 'Placebo - S2', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season'}, {'id': 'FG004', 'title': 'A&D - S3', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season'}, {'id': 'FG005', 'title': 'Placebo - S3', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '14'}]}, {'type': 'Vitamin A Sufficiency (RBP≥22,000 ng/ml)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'Vitamin A Insufficiency (RBP<22,000 ng/m', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '79', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'A&D-S1', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season'}, {'id': 'BG001', 'title': 'Placebo - S1', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season'}, {'id': 'BG002', 'title': 'A&D - S2', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season'}, {'id': 'BG003', 'title': 'Placebo - S2', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season'}, {'id': 'BG004', 'title': 'A&D - S3', 'description': 'Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season'}, {'id': 'BG005', 'title': 'Placebo - S3', 'description': 'Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '79', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '8'}, {'value': '3.5', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '5', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '8'}, {'value': '4', 'groupId': 'BG003', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '3', 'groupId': 'BG004', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '5', 'groupId': 'BG005', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '5', 'groupId': 'BG006', 'lowerLimit': '2', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '46', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '33', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '78', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Black', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '57', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '22', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '79', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-14', 'size': 711078, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-25T11:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-16', 'studyFirstSubmitDate': '2016-01-06', 'resultsFirstSubmitDate': '2019-06-25', 'studyFirstSubmitQcDate': '2016-01-06', 'lastUpdatePostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-30', 'studyFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Positive Responses in Virus-specific Antibody in Sera', 'timeFrame': 'Day 56 after vaccination', 'description': 'The percentage of 2X increases or conversion from undetectable to detectable response in virus-specific antibody toward any vaccine component after 2 immunizations in intervention and control groups will be reported.'}, {'measure': 'Isotype Ratios on Day 56', 'timeFrame': 'Day 56 after vaccination', 'description': 'Isotype ratios will be summarized with descriptive statistics.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Seroconversion at Day 56 After Vaccination, Overall', 'timeFrame': 'Day 56 after vaccination', 'description': 'Secondary analyses will examine sero-conversion based on antibody functions (HAI or neutralization) defined as antibody titers of \\<1:40 converting to ≥1:40, or a four-fold increase in titer for participants with a starting titer of ≥1:40. Sero-conversion rate (expressed as percentage) will be estimated with 95% confidence interval. The rate difference will be described with point estimate and 95% confidence interval.'}, {'measure': 'Percentage of Participants With Seroconversion at Day 56 After Vaccination, by Vitamin A Levels at Screening', 'timeFrame': 'Day 56 after vaccination', 'description': 'Secondary analyses will examine sero-conversion based on antibody functions (HAI or neutralization) defined as antibody titers of \\<1:40 converting to ≥1:40, or a four-fold increase in titer for participants with a starting titer of ≥1:40. Sero-conversion rate (expressed as percentage) will be estimated with 95% confidence interval for participants sufficient and insufficient in vitamin A at screening.'}, {'measure': 'HAI Titers at Day 56 After Vaccination, Overall', 'timeFrame': 'Day 56 after vaccination'}, {'measure': 'HAI Titers at Day 56 After Vaccination, by Vitamin A Levels at Screening', 'timeFrame': 'Day 56 after vaccination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children', 'Vitamin Supplements', 'Influenza virus vaccine'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}, {'url': 'http://www.stjude.org/protocols', 'label': 'Clinical Trials Open at St. Jude'}]}, 'descriptionModule': {'briefSummary': 'Children are particularly vulnerable to respiratory virus infections, especially influenza. Vitamin A \\& D deficiencies are associated with vulnerability to infectious diseases of the respiratory tract. The central hypothesis of this protocol is that vitamin supplements will enhance antibody responses toward the flu vaccine in children. Children, 2-8 years old, will be randomized to receive influenza virus vaccine with a vitamin A+D supplement or influenza virus vaccine with placebo. Children will be tested for vitamin levels and immune responses before and after influenza virus vaccinations to determine if vitamin supplementation improves the influenza virus vaccine-induced immune response.\n\nPRIMARY OBJECTIVE:\n\n* To assess the vaccine-induced and total antibody (including IgG and IgA) response after influenza virus vaccine administration and IgA/IgG plus IgA/IgM ratios at 28 and 56 days in sera\n\nSECONDARY OBJECTIVE:\n\n* To assess the neutralizing response toward influenza virus vaccine in the sera.', 'detailedDescription': 'Participants will be randomized to receive either an influenza virus vaccine plus Vitamins A \\& D or an influenza virus vaccine plus placebo. They will be stratified based on retinol binding protein (RBP) levels at screening, using a cut-off indicative of Vitamin A insufficiency (≤22,000 ng/ml). Co-enrolled sibling participants will be first stratified by RBP levels, then siblings within the same stratum will be equally assigned to different arms to provide greater assurance of balanced treatment assignment. Children will be tested for vitamin levels and immune responses before and after influenza virus vaccinations to determine if vitamin supplementation improves the influenza virus vaccine-induced antibody immune response.\n\nAll participants will receive two doses of an influenza virus vaccination administered at least 28 days apart. Vitamin levels and antibody responses toward the vaccine will be measured on day 0 (baseline levels obtained where day 0 equals the first influenza virus vaccination administration), day 28, and day 56. Placebo or Vitamins A + D (at the levels of 20,000 IU and 2,000 IU, respectively) will be administered orally on the days of vaccination.\n\nBlood serum samples will be collected from participants on Day 0, prior to receiving influenza virus vaccine on Day 28, and during their Day 56 follow-up visit.\n\nParents will be asked to fill out diary cards to indicate food intake for children during the study period along with an optional food frequency questionnaire given on day 56. Specific measurements on days 28, and 56 will include analyses of vaccine-specific and total IgA, IgG, and IgA/IgG plus IgA/IgM ratios in sera. Functional activities of antibodies toward influenza vaccine will also be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resident of the Memphis area community.\n* Parent or legal guardian willing and able to give informed consent and comply with study requirements.\n\nExclusion Criteria:\n\n* Current use of investigational or immunosuppressive drugs (e.g., steroids) at the time of enrollment.\n* Currently taking a daily (routine) vitamin A, D, or multivitamin. Note: participants who report occasional or sporadic vitamin use will be allowed to enroll.\n* History of lung disease, asthma, immunodeficiency, sickle cell disease, or any other serious underlying condition or disease in the opinion of the principal investigator.\n* Evidence of developmental delay or evolving neurological disorders at screening. Current use of antibiotics or antivirals at enrollment.\n* History of having a severe allergy to eggs or to any inactive ingredient in the influenza virus vaccine\n* History of a life-threatening reaction to influenza vaccinations\n* Currently wheezing at the time of enrollment\n* History of heart, kidney, or lung conditions\n* History of diabetes\n* Use of an anti-influenza medication (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to enrollment\n* Acute febrile \\[\\>100.0°F (37.8°C) oral\\] illness or acute respiratory illness (e.g., cough or sore throat) within 3 days prior to enrollment\n* Previous receipt of current seasonal influenza vaccine'}, 'identificationModule': {'nctId': 'NCT02649192', 'briefTitle': 'Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled Study of Antibody Induction by Vitamin Supplementation at the Time of Influenza Virus Vaccinations in Children', 'orgStudyIdInfo': {'id': 'FLUVIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Influenza Virus Vaccine Plus Vitamins A and D', 'description': 'Participants receive influenza virus vaccine and Vitamins A and D supplement on Day 0 and Day 28.', 'interventionNames': ['Biological: Influenza virus vaccine', 'Dietary Supplement: Vitamins A and D']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Influenza Virus Vaccine Plus Placebo', 'description': 'Participants receive influenza virus vaccine and matched placebo on Day 0 and Day 28.', 'interventionNames': ['Biological: Influenza virus vaccine', 'Other: Placebo']}], 'interventions': [{'name': 'Influenza virus vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone®'], 'description': 'Children will have the first influenza virus vaccine dose (dose 1) administered on day 0 of the trial, and the second dose (dose 2) administered 28 days later.', 'armGroupLabels': ['Influenza Virus Vaccine Plus Placebo', 'Influenza Virus Vaccine Plus Vitamins A and D']}, {'name': 'Vitamins A and D', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nutritional Supplement'], 'description': "The chewable gummy contains either Vitamin A (20,000 International Units) and Vitamin D3 (2,000 International Units), which should be fully chewed under supervision of study staff with documentation in the participant's research record and eMAR (electronic medical administration record). The chewable gummy should be administered prior to receiving influenza virus vaccination.", 'armGroupLabels': ['Influenza Virus Vaccine Plus Vitamins A and D']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Look-alike Medication', 'Matched Placebo'], 'description': "The chewable gummy matched placebo will be formulated with gelatin base and tangerine oil and match the Vitamin A and D in shape, taste, texture, and appearance. Gummies should be fully chewed under supervision of study staff with documentation in the participant's research record and eMAR (electronic medical administration record). The chewable gummy should be administered prior to receiving influenza virus vaccination.", 'armGroupLabels': ['Influenza Virus Vaccine Plus Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Nehali Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}