Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-03-01 @ 9:02 AM
Study NCT ID:
NCT02559505
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2015-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Influenza Immunity 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jennifer_Nayak@URMC.Rochester.edu', 'phone': '5852767404', 'title': 'Dr. Jennifer Nayak', 'organization': 'University Of Rochester'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 18 months', 'eventGroups': [{'id': 'EG000', 'title': '6-12 Months: Vaccinated', 'description': 'Children 6 - 12 months of age vaccinated with seasonal IIV\n\nSeasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '3-12 Months: Acute', 'description': 'Children 3-12 months of age presenting with natural influenza infection\n\nNatural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection\n\nSeasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '13-35 Months: Vaccinated', 'description': 'Children 13-35 months of age vaccinated with seasonal IIV\n\nSeasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '13-35 Months: Acute', 'description': 'Children 13-35 months of age presenting with natural influenza infection\n\nNatural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection\n\nSeasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '3-5 Years: Vaccinated', 'description': 'Children 3-5 years of age vaccinated with seasonal IIV\n\nSeasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '3-5 Years: Acute', 'description': 'Children 3-5 years of age presenting with natural influenza infection\n\nNatural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection\n\nSeasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': '6-8 Years: Vaccinated', 'description': 'Children 6-8 years of age vaccinated with seasonal IIV\n\nSeasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': '6-8 Years: Acute', 'description': 'Children 6-8 years of age presenting with natural influenza infection\n\nNatural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection\n\nSeasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acute Infected', 'description': 'Children enrolled on presentation to their primary care provider with a natural influenza infection'}, {'id': 'OG001', 'title': 'Vaccinated', 'description': 'Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age'}], 'classes': [{'title': 'Nucleoprotein', 'categories': [{'measurements': [{'value': '.010', 'spread': '0.0023', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.0018', 'groupId': 'OG001'}]}]}, {'title': 'H3 protein', 'categories': [{'measurements': [{'value': '0.009', 'spread': '0.0019', 'groupId': 'OG000'}, {'value': '0.002', 'spread': '0.0015', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2 (day 8-14 post enrollment)', 'description': '% H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining', 'unitOfMeasure': 'percentage of T cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 acute participants were infected with influenza strains that were not H3 and therefore were not included in the data analyzed for the primary outcome. Only vaccinated participants that age matched to the acute subjects were analyzed, resulting in 16 acutely infected and 28 vaccinated subjects included in the data analysis.'}, {'type': 'PRIMARY', 'title': 'Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acute Infected', 'description': 'Children enrolled on presentation to their primary care provider with a natural influenza infection.'}, {'id': 'OG001', 'title': 'Vaccinated', 'description': 'Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age.'}], 'classes': [{'title': 'Nucleoprotein', 'categories': [{'measurements': [{'value': '0.012', 'spread': '0.0025', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.0017', 'groupId': 'OG001'}]}]}, {'title': 'H3 Protein', 'categories': [{'measurements': [{'value': '0.006', 'spread': '0.0021', 'groupId': 'OG000'}, {'value': '0.004', 'spread': '0.0014', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.408', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 3 (day 20-28 post enrollment)', 'description': '% H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining', 'unitOfMeasure': 'Percentage of T cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 acute participants were infected with influenza strains that were not H3 and therefore were not included in the data analyzed for the primary outcome. Only vaccinated participants that age matched to the acute subjects were analyzed, resulting in 16 acutely infected and 28 vaccinated subjects included in the data analysis.'}, {'type': 'PRIMARY', 'title': 'Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acute Infected', 'description': 'Children enrolled on presentation to their primary care provider with a natural influenza infection'}, {'id': 'OG001', 'title': 'Vaccinated', 'description': 'Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age'}], 'classes': [{'title': 'Nucleoprotein', 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0030', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.0018', 'groupId': 'OG001'}]}]}, {'title': 'H3 Protein', 'categories': [{'measurements': [{'value': '0.007', 'spread': '0.0022', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.0015', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.991', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.334', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 4 (day of vaccination year 2)', 'description': '% H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining', 'unitOfMeasure': 'Percentage of T cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 acute participants were infected with influenza strains that were not H3 and therefore were not included in the data analyzed for the primary outcome. Only vaccinated participants that age matched to the acute subjects were analyzed, resulting in 16 acutely infected and 28 vaccinated subjects included in the data analysis.'}, {'type': 'PRIMARY', 'title': 'Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acute Infected', 'description': 'Children enrolled on presentation to their primary care provider with a natural influenza infection'}, {'id': 'OG001', 'title': 'Vaccinated', 'description': 'Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age'}], 'classes': [{'title': 'Nucleoprotein', 'categories': [{'measurements': [{'value': '0.010', 'spread': '0.0031', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.0018', 'groupId': 'OG001'}]}]}, {'title': 'H3 Protein', 'categories': [{'measurements': [{'value': '0.008', 'spread': '0.0026', 'groupId': 'OG000'}, {'value': '0.004', 'spread': '0.0015', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.226', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 5 (day 8-14 post-vaccination year 2)', 'description': '% H3 protein- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining', 'unitOfMeasure': 'Percentage of T cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 acute participants were infected with influenza strains that were not H3 and therefore were not included in the data analyzed for the primary outcome. Only vaccinated participants that age matched to the acute subjects were analyzed, resulting in 16 acutely infected and 28 vaccinated subjects included in the data analysis.'}, {'type': 'PRIMARY', 'title': 'Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acute Infected', 'description': 'Children enrolled on presentation to their primary care provider with a natural influenza infection.'}, {'id': 'OG001', 'title': 'Vaccinated', 'description': 'Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age'}], 'classes': [{'title': 'Nucleoprotein', 'categories': [{'measurements': [{'value': '0.014', 'spread': '0.0029', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.0019', 'groupId': 'OG001'}]}]}, {'title': 'H3 Protein', 'categories': [{'measurements': [{'value': '0.008', 'spread': '0.0024', 'groupId': 'OG000'}, {'value': '0.007', 'spread': '0.0015', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.680', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 6 (day 20-28 post-vaccination year 2)', 'description': '% H3 Protein- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining', 'unitOfMeasure': 'Percentage of T cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 acute participants were infected with influenza strains that were not H3 and therefore were not included in the data analyzed for the primary outcome. Only vaccinated participants that age matched to the acute subjects were analyzed, resulting in 16 acutely infected and 28 vaccinated subjects included in the data analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccinated Age Subset (6-12 mo)', 'description': 'Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 - 12 months.'}, {'id': 'OG001', 'title': 'Vaccinated Age Subset (13-35 mo)', 'description': 'Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 13 - 35 months.'}, {'id': 'OG002', 'title': 'Vaccinated Age Subset (3-5 yr)', 'description': 'Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 3 - 5 years.'}, {'id': 'OG003', 'title': 'Vaccinated Age Subset (6-8 yr)', 'description': 'Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 - 8 years.'}], 'classes': [{'title': 'HAB', 'categories': [{'measurements': [{'value': '0.00112', 'spread': '0.00290', 'groupId': 'OG000'}, {'value': '0.00497', 'spread': '0.00966', 'groupId': 'OG001'}, {'value': '0.00622', 'spread': '0.01098', 'groupId': 'OG002'}, {'value': '0.01713', 'spread': '0.02657', 'groupId': 'OG003'}]}]}, {'title': 'H3', 'categories': [{'measurements': [{'value': '0.0006729', 'spread': '0.0017802', 'groupId': 'OG000'}, {'value': '0.0002589', 'spread': '0.005017', 'groupId': 'OG001'}, {'value': '0.0053456', 'spread': '0.0101449', 'groupId': 'OG002'}, {'value': '0.001674', 'spread': '0.008319', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to day 24 study year 1', 'description': 'CD4 T cell quantity and specificity will be measured using intracellular cytokine staining. We report here the mean change in percent of cells reactive to the influenza HA protein and H3 protein.', 'unitOfMeasure': 'Mean Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical analysis was completed on all patients who attended all six clinical visits in addition to those who had 3 or more visits that had withdrawn later.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccinated Age Subset (6-12 mo)', 'description': 'Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 - 12 months.'}, {'id': 'OG001', 'title': 'Vaccinated Age Subset (13-35 mo)', 'description': 'Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 13 - 35 months.'}, {'id': 'OG002', 'title': 'Vaccinated Age Subset (3-5 yr)', 'description': 'Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 3 - 5 years.'}, {'id': 'OG003', 'title': 'Vaccinated Age Subset (6-8 yr)', 'description': 'Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 - 8 years.'}], 'classes': [{'title': 'HAB', 'categories': [{'measurements': [{'value': '0.00552', 'spread': '0.01436', 'groupId': 'OG000'}, {'value': '0.00331', 'spread': '0.01216', 'groupId': 'OG001'}, {'value': '0.00003', 'spread': '0.01096', 'groupId': 'OG002'}, {'value': '0.005698', 'spread': '0.01729', 'groupId': 'OG003'}]}]}, {'title': 'H3', 'categories': [{'measurements': [{'value': '0.00350', 'spread': '0.00372', 'groupId': 'OG000'}, {'value': '0.00177', 'spread': '0.00371', 'groupId': 'OG001'}, {'value': '0.00188', 'spread': '0.00650', 'groupId': 'OG002'}, {'value': '-0.0017093', 'spread': '0.01015', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to day 24 study year 2', 'description': 'CD4 T cell quantity and specificity will be measured using intracellular cytokine staining. We report here the mean change in percent of cells reactive to the influenza HA protein and H3 protein.', 'unitOfMeasure': 'Mean Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical analysis was completed on all patients who attended all six clinical visits in addition to those who had 3 or more visits that had withdrawn later.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline to Day 10 and Day 24 in PBMC Gene Expression', 'timeFrame': 'Days 10 and 24 post vaccination', 'description': 'Changes in PBMC gene expression patterns due to prior influenza exposure will be assessed using RNA-seq analysis', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acute', 'description': 'Children enrolled on presentation to their primary care provider with a natural influenza infection.'}, {'id': 'FG001', 'title': 'Vaccinated', 'description': 'Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '132', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': '6-12 Months of Age: Vaccinated', 'description': 'Children 6 - 12 months of age vaccinated with seasonal IIV\n\nSeasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age'}, {'id': 'BG001', 'title': '3-12 Months of Age: Acute', 'description': 'Children 3-12 months of age presenting with natural influenza infection\n\nNatural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection\n\nSeasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age'}, {'id': 'BG002', 'title': '13-35 Months of Age: Vaccinated', 'description': 'Children 13-35 months of age vaccinated with seasonal IIV\n\nSeasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age'}, {'id': 'BG003', 'title': '13-35 Months of Age: Acute', 'description': 'Children 13-35 months of age presenting with natural influenza infection\n\nNatural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection\n\nSeasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age'}, {'id': 'BG004', 'title': '3-5 Years of Age: Vaccinated', 'description': 'Children 3-5 years of age vaccinated with seasonal IIV\n\nSeasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age'}, {'id': 'BG005', 'title': '3-5 Years of Age: Acute', 'description': 'Children 3-5 years of age presenting with natural influenza infection\n\nNatural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection\n\nSeasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age'}, {'id': 'BG006', 'title': '6-8 Years of Age: Vaccinated', 'description': 'Children 6-8 years of age vaccinated with seasonal IIV\n\nSeasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age'}, {'id': 'BG007', 'title': '6-8 Years of Age: Acute', 'description': 'Children 6-8 years of age presenting with natural influenza infection\n\nNatural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection\n\nSeasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '132', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '64', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '68', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '117', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', '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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', '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': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Asian', '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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', '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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '39', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '62', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '25', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '132', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-21', 'size': 852775, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-08T13:26', 'hasProtocol': True}, {'date': '2015-09-04', 'size': 299595, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-07-02T10:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-05', 'studyFirstSubmitDate': '2015-09-18', 'resultsFirstSubmitDate': '2021-08-05', 'studyFirstSubmitQcDate': '2015-09-22', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-05', 'studyFirstPostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline to Day 10 and Day 24 in PBMC Gene Expression', 'timeFrame': 'Days 10 and 24 post vaccination', 'description': 'Changes in PBMC gene expression patterns due to prior influenza exposure will be assessed using RNA-seq analysis'}], 'primaryOutcomes': [{'measure': 'Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects', 'timeFrame': 'Visit 2 (day 8-14 post enrollment)', 'description': '% H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining'}, {'measure': 'Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects', 'timeFrame': 'Visit 3 (day 20-28 post enrollment)', 'description': '% H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining'}, {'measure': 'Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects', 'timeFrame': 'Visit 4 (day of vaccination year 2)', 'description': '% H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining'}, {'measure': 'Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects', 'timeFrame': 'Visit 5 (day 8-14 post-vaccination year 2)', 'description': '% H3 protein- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining'}, {'measure': 'Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects', 'timeFrame': 'Visit 6 (day 20-28 post-vaccination year 2)', 'description': '% H3 Protein- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining'}], 'secondaryOutcomes': [{'measure': 'Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets', 'timeFrame': 'Baseline to day 24 study year 1', 'description': 'CD4 T cell quantity and specificity will be measured using intracellular cytokine staining. We report here the mean change in percent of cells reactive to the influenza HA protein and H3 protein.'}, {'measure': 'Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets', 'timeFrame': 'Baseline to day 24 study year 2', 'description': 'CD4 T cell quantity and specificity will be measured using intracellular cytokine staining. We report here the mean change in percent of cells reactive to the influenza HA protein and H3 protein.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['natural influenza infection', 'live attenuated influenza vaccination (LAIV)', 'inactivated influenza vaccination (IIV)', 'infants', 'children'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '33074330', 'type': 'DERIVED', 'citation': 'Shannon I, White CL, Yang H, Nayak JL. Differences in Influenza-Specific CD4 T-Cell Mediated Immunity Following Acute Infection Versus Inactivated Vaccination in Children. J Infect Dis. 2021 Jun 15;223(12):2164-2173. doi: 10.1093/infdis/jiaa664.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates how different methods of early exposure to influenza (natural infection, live attenuated influenza vaccination, inactivated influenza vaccination) initially stimulate immunity and poise the immune system to respond to a future challenge with the inactivated influenza vaccine.', 'detailedDescription': "The proposed research addresses the fact that, despite high childhood morbidity from influenza and broad recommendations for vaccination, very little is known about how anti-influenza immunity is shaped by the method of initial exposure. The objective of this research is to understand how CD4 T cell and B cell responses are altered by the method of initial influenza priming, with the long-term goal of determining how a child's initial influenza encounter poises the immune system to respond to subsequent influenza challenges. The investigators central hypothesis is that differences in the mode of influenza antigen exposure in early childhood will generate long lasting, detectable changes in memory CD4 T cell and B cell specificity and function that influence the response to future influenza vaccinations and infections. This hypothesis will be tested by comparing 1) CD4 T cell and 2) antibody responses in cohorts of children initially exposed to influenza through either natural infection or inactivated or live attenuated vaccination. A combination of multiparameter assays will be used to determine the phenotype and functional potential of hemagglutinin (HA)- and nucleoprotein (NP)-specific CD4 T cells. The breadth and avidity of the neutralizing and non-neutralizing antibody responses and its distribution against head and stalk epitopes will also be evaluated. By determining how initial priming shapes the specificity and functional potential of the anti-influenza CD4 T cell and antibody responses, the investigators will gain the knowledge necessary to optimize current influenza vaccination strategies and develop novel influenza vaccines able to provide highly efficacious universal protection against both seasonal and potentially pandemic viral strains."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '3 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\n\n * Between 6 and 12 months to participate in the vaccination arm of cohort 1 (cohort 1A)\n * Between 3 and 12 months to participate in the natural infection arm of cohort 1 (cohort 1B)\n * Between 13 and 35 months of age to participate in either the vaccination or natural infection arm of cohort 2\n * Between 36 months and 5 years of age to participate in either the vaccination or natural infection arm of cohort 3\n * Between 6 years and 8 years of age to participate in either the vaccination or natural infection arm of cohort 4\n* Gestational age of ≥37 weeks at birth\n* Parent/guardian can provide informed consent\n* Available for the duration of the study\n* History of previous IIV administration ONLY for participation in the vaccination arm of cohorts 2, 3, or 4\n* Acute illness documented to be due to influenza virus ONLY for participation in the natural infection arms of cohorts 1-4\n\nExclusion Criteria:\n\n* Immunosuppression as a result of an underlying illness or condition (including HIV or a primary immunodeficiency syndrome)\n* Active neoplastic disease\n* Use of potentially immunosuppressive medications currently or within the past year (including chemotherapeutic agents) or chronic (\\>2 weeks) use of oral or inhaled steroid therapy\n* A diagnosis of asthma requiring chronic controller medication\n* Previous administration of influenza vaccine in the current influenza season ONLY for subjects receiving an influenza vaccination\n* Receipt of immunoglobulin or another blood product within the year prior to study enrollment\n* An acute illness within the previous 3 days or temperature \\>38o on screening EXCEPT for participation in the natural infection arms of cohorts 1-4\n* A contraindication to influenza vaccination EXCEPT infants between 3 and 5 months presenting with natural influenza infection whose only contraindication is their current age'}, 'identificationModule': {'nctId': 'NCT02559505', 'briefTitle': 'Influenza Immunity in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Understanding How the Initial Encounter With Influenza Virus Poises Children for Protective Immunity', 'orgStudyIdInfo': {'id': 'RSRB00058437'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '6-12 months Seasonal IIV', 'description': 'Children 6 - 12 months of age vaccinated with seasonal IIV', 'interventionNames': ['Biological: Seasonal IIV 0.25 mL dose']}, {'type': 'EXPERIMENTAL', 'label': '3-12 months natural infection', 'description': 'Children 3-12 months of age presenting with natural influenza infection', 'interventionNames': ['Other: Natural influenza infection', 'Biological: Seasonal IIV 0.5 mL dose']}, {'type': 'EXPERIMENTAL', 'label': '13-35 months Seasonal IIV', 'description': 'Children 13-35 months of age vaccinated with seasonal IIV', 'interventionNames': ['Biological: Seasonal IIV 0.25 mL dose']}, {'type': 'EXPERIMENTAL', 'label': '13-35 months natural infection', 'description': 'Children 13-35 months of age presenting with natural influenza infection', 'interventionNames': ['Other: Natural influenza infection', 'Biological: Seasonal IIV 0.5 mL dose']}, {'type': 'EXPERIMENTAL', 'label': '3-5 years Seasonal IIV', 'description': 'Children 3-5 years of age vaccinated with seasonal IIV', 'interventionNames': ['Biological: Seasonal IIV 0.5 mL dose']}, {'type': 'EXPERIMENTAL', 'label': '3-5 years natural infection', 'description': 'Children 3-5 years of age presenting with natural influenza infection', 'interventionNames': ['Other: Natural influenza infection', 'Biological: Seasonal IIV 0.5 mL dose']}, {'type': 'EXPERIMENTAL', 'label': '6-8 years Seasonal IIV', 'description': 'Children 6-8 years of age vaccinated with seasonal IIV', 'interventionNames': ['Biological: Seasonal IIV 0.5 mL dose']}, {'type': 'EXPERIMENTAL', 'label': '6-8 years natural infection', 'description': 'Children 6-8 years of age presenting with natural influenza infection', 'interventionNames': ['Other: Natural influenza infection', 'Biological: Seasonal IIV 0.5 mL dose']}], 'interventions': [{'name': 'Seasonal IIV 0.25 mL dose', 'type': 'BIOLOGICAL', 'otherNames': ['Inactivated influenza vaccine'], 'description': 'Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age', 'armGroupLabels': ['13-35 months Seasonal IIV', '6-12 months Seasonal IIV']}, {'name': 'Natural influenza infection', 'type': 'OTHER', 'description': 'Children enrolled on presentation to their primary care provider with a natural influenza infection', 'armGroupLabels': ['13-35 months natural infection', '3-12 months natural infection', '3-5 years natural infection', '6-8 years natural infection']}, {'name': 'Seasonal IIV 0.5 mL dose', 'type': 'BIOLOGICAL', 'otherNames': ['inactivated influenza vaccine'], 'description': 'Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age', 'armGroupLabels': ['13-35 months natural infection', '3-12 months natural infection', '3-5 years Seasonal IIV', '3-5 years natural infection', '6-8 years Seasonal IIV', '6-8 years natural infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Jennifer L Nayak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jennifer Nayak', 'investigatorAffiliation': 'University of Rochester'}}}}