Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-03 @ 11:55 PM
Study NCT ID:
NCT02915302
Status:
COMPLETED
Last Update Posted:
2022-03-29
First Post:
2016-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy 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': 'RegistryContactUs@sanofipasteur.com', 'phone': '800-633-1610', 'title': 'Medical Director', 'phoneExt': '1#', 'organization': 'Sanofi Pasteur Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 28 post-final vaccination.', 'description': 'All AEs were presented.', 'eventGroups': [{'id': 'EG000', 'title': 'Fluzone Quadrivalent Vaccine, 0.25-mL', 'description': 'Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.', 'otherNumAtRisk': 949, 'deathsNumAtRisk': 949, 'otherNumAffected': 698, 'seriousNumAtRisk': 949, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Fluzone Quadrivalent Vaccine, 0.5-mL', 'description': 'Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.', 'otherNumAtRisk': 992, 'deathsNumAtRisk': 992, 'otherNumAffected': 737, 'seriousNumAtRisk': 992, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 58}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 115}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 109}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 302}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 321}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 210}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 228}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 430}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 473}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 138}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 151}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 164}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 70}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 249}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 267}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 292}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 294}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 431}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 458}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 107}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 74}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}], 'seriousEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Accidental exposure to product by child', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}, {'term': 'Urticaria chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 992, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Fever (Fever Rate) Following Vaccination With Fluzone Quadrivalent Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '930', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone Quadrivalent Vaccine, 0.25-mL', 'description': 'Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.'}, {'id': 'OG001', 'title': 'Fluzone Quadrivalent Vaccine, 0.5-mL', 'description': 'Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.31', 'groupId': 'OG000', 'lowerLimit': '9.31', 'upperLimit': '13.57'}, {'value': '12.15', 'groupId': 'OG001', 'lowerLimit': '10.12', 'upperLimit': '14.42'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Fever Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '-2.13', 'ciUpperLimit': '3.80', 'estimateComment': 'Fever rate: Fluzone Quadrivalent vaccine (0.5-mL vs. 0.25-mL)', 'groupDescription': 'Difference in fever rate was defined as the fever rate following a 0.5-mL dose of Fluzone Quadrivalent vaccine minus the fever rate following a 0.25-mL dose of Fluzone Quadrivalent vaccine.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the difference in fever rate was \\<5%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after any vaccination', 'description': 'Fever rate was defined as percentage of participants with fever (temperature \\>=100.4 degrees Fahrenheit \\[38.0 degrees Celsius\\]) following vaccination with Fluzone Quadrivalent vaccine.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed using the safety analysis set. Here, 'Number of participants analyzed' = those participants with available data for this endpoint."}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '525', 'groupId': 'OG000'}, {'value': '543', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone Quadrivalent Vaccine, 0.25-mL', 'description': 'Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.'}, {'id': 'OG001', 'title': 'Fluzone Quadrivalent Vaccine, 0.5-mL', 'description': 'Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.'}], 'classes': [{'title': 'A/H1N1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '520', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000', 'lowerLimit': '185', 'upperLimit': '247'}, {'value': '310', 'groupId': 'OG001', 'lowerLimit': '271', 'upperLimit': '354'}]}]}, {'title': 'A/H3N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '525', 'groupId': 'OG000'}, {'value': '542', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000', 'lowerLimit': '191', 'upperLimit': '256'}, {'value': '332', 'groupId': 'OG001', 'lowerLimit': '290', 'upperLimit': '380'}]}]}, {'title': 'B Victoria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '520', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '261', 'groupId': 'OG000', 'lowerLimit': '227', 'upperLimit': '299'}, {'value': '348', 'groupId': 'OG001', 'lowerLimit': '304', 'upperLimit': '398'}]}]}, {'title': 'B Yamagata', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}, {'value': '543', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000', 'lowerLimit': '213', 'upperLimit': '277'}, {'value': '349', 'groupId': 'OG001', 'lowerLimit': '307', 'upperLimit': '397'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMTs Ratio (A/H1N1)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '1.19', 'ciUpperLimit': '1.77', 'estimateComment': 'A/H1N1 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)', 'groupDescription': 'For A/H1N1 strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \\>0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMTs Ratio (A/H3N2)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '1.23', 'ciUpperLimit': '1.83', 'estimateComment': 'A/H3N2 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)', 'groupDescription': 'For A/H3N2 strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \\>0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMTs Ratio (B Victoria lineage)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '1.10', 'ciUpperLimit': '1.62', 'estimateComment': 'B Victoria lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)', 'groupDescription': 'For B Victoria lineage strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \\>0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMTs Ratio (B Yamagata lineage)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.44', 'ciLowerLimit': '1.20', 'ciUpperLimit': '1.73', 'estimateComment': 'B Yamagata lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)', 'groupDescription': 'For B Yamagata lineage strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \\>0.667.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '28 days post-final vaccination', 'description': 'Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage.', 'unitOfMeasure': 'Titers (1/dilutions [dil])', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed using Per-protocol (PP) analysis set which included participants who received at least 1 dose of study vaccine and had a valid post-vaccination serologic result for at least 1 strain without any protocol deviations. Here, 'Number Analyzed' = those participants with available data for specified categories."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seroconversion (Seroconversion Rate [SCR]) to Influenza Vaccine Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '525', 'groupId': 'OG000'}, {'value': '543', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone Quadrivalent Vaccine, 0.25-mL', 'description': 'Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.'}, {'id': 'OG001', 'title': 'Fluzone Quadrivalent Vaccine, 0.5-mL', 'description': 'Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.'}], 'classes': [{'title': 'A/H1N1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '470', 'groupId': 'OG000'}, {'value': '483', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000', 'lowerLimit': '75.0', 'upperLimit': '82.5'}, {'value': '84.1', 'groupId': 'OG001', 'lowerLimit': '80.5', 'upperLimit': '87.2'}]}]}, {'title': 'A/H3N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '475', 'groupId': 'OG000'}, {'value': '487', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.9', 'groupId': 'OG000', 'lowerLimit': '78.1', 'upperLimit': '85.3'}, {'value': '86.2', 'groupId': 'OG001', 'lowerLimit': '82.9', 'upperLimit': '89.2'}]}]}, {'title': 'B Victoria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '470', 'groupId': 'OG000'}, {'value': '483', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.2', 'groupId': 'OG000', 'lowerLimit': '83.9', 'upperLimit': '90.1'}, {'value': '88.6', 'groupId': 'OG001', 'lowerLimit': '85.4', 'upperLimit': '91.3'}]}]}, {'title': 'B Yamagata', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'OG000'}, {'value': '488', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000', 'lowerLimit': '84.5', 'upperLimit': '90.6'}, {'value': '91.2', 'groupId': 'OG001', 'lowerLimit': '88.3', 'upperLimit': '93.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in SCR (A/H1N1)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.1', 'ciLowerLimit': '0.189', 'ciUpperLimit': '10.0', 'estimateComment': 'A/H1N1 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)', 'groupDescription': 'For A/H1N1 strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \\>-10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in SCR (A/H3N2)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '-0.283', 'ciUpperLimit': '8.99', 'estimateComment': 'A/H3N2 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)', 'groupDescription': 'For A/H3N2 strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \\>-10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in SCR (B Victoria lineage)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-2.78', 'ciUpperLimit': '5.56', 'estimateComment': 'B Victoria lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)', 'groupDescription': 'For B Victoria lineage strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \\>-10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in SCR (B Yamagata lineage)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '-0.465', 'ciUpperLimit': '7.36', 'estimateComment': 'B Yamagata lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)', 'groupDescription': 'For B Yamagata lineage strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \\>-10%.'}], 'paramType': 'NUMBER', 'timeFrame': '28 days post-final vaccination', 'description': 'Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. SCR was defined as percentage of participants with either a pre-vaccination titer \\<10 (1/dil) and a post-final vaccination titer \\>=40 (1/dil), or a pre-vaccination titer \\>=10 (1/dil) and at least a four-fold increase in post-final vaccination titer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed using the PP analysis set. Here, 'Number Analyzed' = those participants with available data for specified categories."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluzone Quadrivalent Vaccine, 0.25-mL', 'description': 'Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.'}, {'id': 'FG001', 'title': 'Fluzone Quadrivalent Vaccine, 0.5-mL', 'description': 'Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '955'}, {'groupId': 'FG001', 'numSubjects': '995'}]}, {'type': 'Vaccinated (Safety Analysis Set)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '949'}, {'groupId': 'FG001', 'numSubjects': '992'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '890'}, {'groupId': 'FG001', 'numSubjects': '917'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '78'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study participants were enrolled in 38 centers in the United States from 23 September 2016 to 02 January 2017.', 'preAssignmentDetails': 'A total of 1950 participants were randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '949', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '1941', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluzone Quadrivalent Vaccine, 0.25-mL', 'description': 'Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.'}, {'id': 'BG001', 'title': 'Fluzone Quadrivalent Vaccine, 0.5-mL', 'description': 'Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.4', 'spread': '8.75', 'groupId': 'BG000'}, {'value': '20.5', 'spread': '8.55', 'groupId': 'BG001'}, {'value': '20.5', 'spread': '8.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '469', 'groupId': 'BG000'}, {'value': '495', 'groupId': 'BG001'}, {'value': '964', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '480', 'groupId': 'BG000'}, {'value': '497', 'groupId': 'BG001'}, {'value': '977', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '427', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '731', 'groupId': 'BG000'}, {'value': '763', 'groupId': 'BG001'}, {'value': '1494', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '178', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '373', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '717', 'groupId': 'BG000'}, {'value': '725', 'groupId': 'BG001'}, {'value': '1442', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '949', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '1941', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Analysis was performed using the safety analysis set which included those participants who received at least 1 dose of study vaccine.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-13', 'size': 445450, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-05T09:45', 'hasProtocol': True}, {'date': '2017-07-20', 'size': 15734849, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-03-05T09:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1950}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-23'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2016-09-23', 'resultsFirstSubmitDate': '2018-03-06', 'studyFirstSubmitQcDate': '2016-09-23', 'lastUpdatePostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-06', 'studyFirstPostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Fever (Fever Rate) Following Vaccination With Fluzone Quadrivalent Vaccine', 'timeFrame': 'Within 7 days after any vaccination', 'description': 'Fever rate was defined as percentage of participants with fever (temperature \\>=100.4 degrees Fahrenheit \\[38.0 degrees Celsius\\]) following vaccination with Fluzone Quadrivalent vaccine.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies', 'timeFrame': '28 days post-final vaccination', 'description': 'Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage.'}, {'measure': 'Percentage of Participants With Seroconversion (Seroconversion Rate [SCR]) to Influenza Vaccine Antigens', 'timeFrame': '28 days post-final vaccination', 'description': 'Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. SCR was defined as percentage of participants with either a pre-vaccination titer \\<10 (1/dil) and a post-final vaccination titer \\>=40 (1/dil), or a pre-vaccination titer \\>=10 (1/dil) and at least a four-fold increase in post-final vaccination titer.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza', 'Influenza virus vaccine', 'Fluzone® Quadrivalent Influenza Vaccine (No Preservative)'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '30395011', 'type': 'DERIVED', 'citation': 'Robertson CA, Mercer M, Selmani A, Klein NP, Jeanfreau R, Greenberg DP. Safety and Immunogenicity of a Full-dose, Split-virion, Inactivated, Quadrivalent Influenza Vaccine in Healthy Children 6-35 Months of Age: A Randomized Controlled Clinical Trial. Pediatr Infect Dis J. 2019 Mar;38(3):323-328. doi: 10.1097/INF.0000000000002227.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study was to describe the safety and immunogenicity of a 0.5-mL dose (15 μg hemagglutinin \\[HA\\] per strain) of Fluzone Quadrivalent vaccine in children 6 to \\<36 months of age.\n\nPrimary objective:\n\n* To compare the rate of any fever (temperature ≥100.4 degrees Fahrenheit \\[38.0 degrees Celsius) following a 0.5-mL dose of Fluzone Quadrivalent vaccine to that following a 0.25-mL dose of Fluzone Quadrivalent vaccine during the 7 days after either vaccination (Dose 1 and Dose 2 combined) in participants 6 to \\< 36 months of age.\n\nSecondary objective:\n\n* To compare antibody responses induced by a 0.5-mL dose of Fluzone Quadrivalent vaccine to those induced by a 0.25-mL dose of Fluzone Quadrivalent vaccine as assessed by geometric mean titer (GMT) ratios and seroconversion rate differences after the final vaccination in participants 6 to \\< 36 months of age.\n\nOther objectives:\n\n* To describe the safety of 2 different dose levels of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in participants 6 to \\< 36 months of age.\n* To describe the immunogenicity of 2 different dose levels of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in participants 6 months to \\< 36 months of age.\n* To submit available sera from approximately 30 participants to the Center for Biologics Evaluation and Research for further analysis by the World Health Organization, the Centers for Disease Control and Prevention, and the FDA to support formulation recommendations for subsequent influenza vaccines.', 'detailedDescription': 'All participants received 1 intramuscular dose of Fluzone Quadrivalent vaccine during Visit 1. For participants, for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine (of the same volume as the first dose) was administered during Visit 2 (28 days after Visit 1).\n\nSolicited adverse event (AE) information was collected for 7 days after each vaccination, unsolicited AE information was collected from Visit 1 to Visit 2 or to Visit 3 for participants receiving 2 doses of study vaccine. Serious adverse event (SAE) information was collected for 28 days after each vaccination.\n\nImmunogenicity was evaluated in a planned subset of 1600 randomly selected participants prior to vaccination on Day 0 (Visit 1) and at Day 28 after the final vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '35 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 6 to \\< 36 months of age on the day of first study vaccination (study product administration).\n* Born at full term of pregnancy (≥37 weeks) and/or with a birth weight ≥2.5 kg. Note: This inclusion criterion only applies to participants 6 to \\<12 months of age on the day of the first study visit.\n* Informed consent form has been signed and dated by the parent(s) or guardian(s).\n* Participant and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.\n\nExclusion Criteria:\n\n* Participation at the time of study enrollment (or in the 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.\n* Receipt of any vaccine in the 30 days preceding the first trial vaccination, or planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine.\n* Previous vaccination against influenza (in the 2016-2017 season) with either the trial vaccine or another vaccine.\n* Receipt of immune globulins, blood, or blood-derived products in the past 3 months.\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).\n* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.\n* Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.\n* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.\n* Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.\n* Moderate or severe acute illness/infection (according to Investigator judgment) on the day of planned vaccination or febrile illness (temperature ≥100.4 degrees Fahrenheit \\[38.0 degrees Celsius\\]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.\n* Identified as a natural or adopted child of either the Investigator or an employee with direct involvement in the proposed study.\n* History of serious adverse reactions to any influenza vaccine.\n* Personal history of Guillain-Barré syndrome.\n* Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine.\n* Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder.\n* Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.'}, 'identificationModule': {'nctId': 'NCT02915302', 'briefTitle': 'Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children 6 to < 36 Months of Age', 'orgStudyIdInfo': {'id': 'GRC88'}, 'secondaryIdInfos': [{'id': 'U1111-1143-9273', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fluzone Quadrivalent Vaccine, 0.25-mL', 'description': 'Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.', 'interventionNames': ['Biological: Fluzone Quadrivalent vaccine, No Preservative']}, {'type': 'EXPERIMENTAL', 'label': 'Fluzone Quadrivalent Vaccine, 0.5-mL', 'description': 'Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.', 'interventionNames': ['Biological: Fluzone Quadrivalent vaccine, No Preservative']}], 'interventions': [{'name': 'Fluzone Quadrivalent vaccine, No Preservative', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone® Quadrivalent Influenza Vaccine'], 'description': '0.25-mL (Pediatric Dose), Intramuscular (2016-2017 formulation)', 'armGroupLabels': ['Fluzone Quadrivalent Vaccine, 0.25-mL']}, {'name': 'Fluzone Quadrivalent vaccine, No Preservative', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone® Quadrivalent Influenza Vaccine'], 'description': '0.5-mL, Intramuscular (2016-2017 formulation)', 'armGroupLabels': ['Fluzone Quadrivalent Vaccine, 0.5-mL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': 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'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '40004', 'city': 'Bardstown', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.80923, 'lon': -85.4669}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '68504', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68505', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68516', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68701', 'city': 'Norfolk', 'state': 'Nebraska', 'country': 'United 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'29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37388', 'city': 'Tullahoma', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.36202, 'lon': -86.20943}}, {'zip': '76107', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77055', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84041', 'city': 'Layton', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 41.06022, 'lon': -111.97105}}, {'zip': '84057', 'city': 'Orem', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.2969, 'lon': -111.69465}}, {'zip': '84604', 'city': 'Provo', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.23384, 'lon': -111.65853}}, {'zip': '84067', 'city': 'Roy', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 41.16161, 'lon': -112.02633}}, {'zip': '84095', 'city': 'South Jordan', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}, {'zip': '22015', 'city': 'Burke', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.79345, 'lon': -77.27165}}, {'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'country': 'United Kingdom'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}