Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-22 @ 4:35 AM
Study NCT ID:
NCT02451358
Status:
COMPLETED
Last Update Posted:
2022-04-19
First Post:
2015-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of a Single Dose or Two Doses of a Quadrivalent Influenza Vaccine in Subjects Aged 6 Months or Older in India
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'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, '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 events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)', 'description': 'A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months', 'description': 'Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 29, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years', 'description': 'Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 50, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years', 'description': 'Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 44, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Quadrivalent Influenza Vaccine Group 4: >=18 Years', 'description': 'Participants aged \\>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 24, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 100, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months', 'description': 'Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.'}, {'id': 'OG001', 'title': 'Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years', 'description': 'Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.'}, {'id': 'OG002', 'title': 'Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years', 'description': 'Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.'}, {'id': 'OG003', 'title': 'Quadrivalent Influenza Vaccine Group 4: >=18 Years', 'description': 'Participants aged \\>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.'}], 'classes': [{'title': 'Pre-Vaccination: A/H1N1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '9.83', 'upperLimit': '21.1'}, {'value': '84.1', 'groupId': 'OG001', 'lowerLimit': '53.6', 'upperLimit': '132'}, {'value': '107', 'groupId': 'OG002', 'lowerLimit': '83.4', 'upperLimit': '138'}, {'value': '44.3', 'groupId': 'OG003', 'lowerLimit': '31.8', 'upperLimit': '61.6'}]}]}, {'title': 'Pre-Vaccination: A/H3N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '26.6', 'upperLimit': '74.2'}, {'value': '416', 'groupId': 'OG001', 'lowerLimit': '311', 'upperLimit': '555'}, {'value': '204', 'groupId': 'OG002', 'lowerLimit': '150', 'upperLimit': '277'}, {'value': '20.8', 'groupId': 'OG003', 'lowerLimit': '15.8', 'upperLimit': '27.3'}]}]}, {'title': 'Pre-Vaccination: B Victoria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '32.8'}, {'value': '37.5', 'groupId': 'OG001', 'lowerLimit': '23.8', 'upperLimit': '59.1'}, {'value': '54.1', 'groupId': 'OG002', 'lowerLimit': '41.4', 'upperLimit': '70.6'}, {'value': '41.9', 'groupId': 'OG003', 'lowerLimit': '31.9', 'upperLimit': '55.0'}]}]}, {'title': 'Pre-Vaccination: B Yamagata', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '8.82', 'upperLimit': '16.3'}, {'value': '81.1', 'groupId': 'OG001', 'lowerLimit': '53.9', 'upperLimit': '122'}, {'value': '91.7', 'groupId': 'OG002', 'lowerLimit': '67.2', 'upperLimit': '125'}, {'value': '107', 'groupId': 'OG003', 'lowerLimit': '79.5', 'upperLimit': '144'}]}]}, {'title': 'Post-Vaccination: A/H1N1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '723', 'groupId': 'OG000', 'lowerLimit': '527', 'upperLimit': '993'}, {'value': '1895', 'groupId': 'OG001', 'lowerLimit': '1550', 'upperLimit': '2318'}, {'value': '1641', 'groupId': 'OG002', 'lowerLimit': '1398', 'upperLimit': '1927'}, {'value': '1232', 'groupId': 'OG003', 'lowerLimit': '969', 'upperLimit': '1565'}]}]}, {'title': 'Post-Vaccination: A/H3N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1016', 'groupId': 'OG000', 'lowerLimit': '697', 'upperLimit': '1482'}, {'value': '3458', 'groupId': 'OG001', 'lowerLimit': '3011', 'upperLimit': '3971'}, {'value': '2379', 'groupId': 'OG002', 'lowerLimit': '1994', 'upperLimit': '2838'}, {'value': '980', 'groupId': 'OG003', 'lowerLimit': '736', 'upperLimit': '1306'}]}]}, {'title': 'Post-Vaccination: B Victoria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '658', 'groupId': 'OG000', 'lowerLimit': '441', 'upperLimit': '982'}, {'value': '2222', 'groupId': 'OG001', 'lowerLimit': '1820', 'upperLimit': '2713'}, {'value': '2061', 'groupId': 'OG002', 'lowerLimit': '1622', 'upperLimit': '2617'}, {'value': '1150', 'groupId': 'OG003', 'lowerLimit': '913', 'upperLimit': '1447'}]}]}, {'title': 'Post-Vaccination: B Yamagata', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '951', 'groupId': 'OG000', 'lowerLimit': '675', 'upperLimit': '1338'}, {'value': '3582', 'groupId': 'OG001', 'lowerLimit': '3054', 'upperLimit': '4201'}, {'value': '2273', 'groupId': 'OG002', 'lowerLimit': '1750', 'upperLimit': '2951'}, {'value': '1836', 'groupId': 'OG003', 'lowerLimit': '1413', 'upperLimit': '2385'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)', 'description': 'Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.', 'unitOfMeasure': 'Titers (1/dilutions)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed using Full Analysis Set (FAS) which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Seroprotection to Influenza Vaccine Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months', 'description': 'Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.'}, {'id': 'OG001', 'title': 'Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years', 'description': 'Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.'}, {'id': 'OG002', 'title': 'Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years', 'description': 'Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.'}, {'id': 'OG003', 'title': 'Quadrivalent Influenza Vaccine Group 4: >=18 Years', 'description': 'Participants aged \\>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.'}], 'classes': [{'title': 'Pre-Vaccination: A/H1N1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}]}, {'title': 'Pre-Vaccination: A/H3N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}]}, {'title': 'Pre-Vaccination: B Victoria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}]}, {'title': 'Pre-Vaccination: B Yamagata', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}]}, {'title': 'Post-Vaccination: A/H1N1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}]}, {'title': 'Post-Vaccination: A/H3N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}]}, {'title': 'Post-Vaccination: B Victoria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}]}, {'title': 'Post-Vaccination: B Yamagata', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)', 'description': 'Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer \\>=40 (1/dilution\\[dil\\]) at pre-vaccination and at post-final vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed using FAS which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months', 'description': 'Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.'}, {'id': 'OG001', 'title': 'Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years', 'description': 'Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.'}, {'id': 'OG002', 'title': 'Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years', 'description': 'Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.'}, {'id': 'OG003', 'title': 'Quadrivalent Influenza Vaccine Group 4: >=18 Years', 'description': 'Participants aged \\>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.'}], 'classes': [{'title': 'A/H1N1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}]}, {'title': 'A/H3N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}]}, {'title': 'B Victoria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}]}, {'title': 'B Yamagata', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days post-final vaccination (post-vaccination)', 'description': 'Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer \\<10 (1/dil) and post-vaccination titer \\>=40 (1/dil), and Significant increase was defined as pre-vaccination titer \\>=10 (1/dil) and \\>= 4-fold increase of post-vaccination titer.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed using FAS which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories."}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months', 'description': 'Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.'}, {'id': 'OG001', 'title': 'Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years', 'description': 'Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.'}, {'id': 'OG002', 'title': 'Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years', 'description': 'Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.'}, {'id': 'OG003', 'title': 'Quadrivalent Influenza Vaccine Group 4: >=18 Years', 'description': 'Participants aged \\>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.'}], 'classes': [{'title': 'Injection site Pain / Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3: Injection site Pain / Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection site Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Injection site Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection site Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Injection site Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Crying abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Crying abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Drowsiness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Drowsiness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Appetite lost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Appetite lost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Irritability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Irritability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Malaise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Malaise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Myalgia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Myalgia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Shivering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Shivering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days after any vaccination', 'description': '1. Solicited injection site reactions:\n\n * Age 6-23 months: Tenderness, Erythema and Swelling(Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling:\\>=50 mm)\n * Age \\>=2 years: Pain, Erythema and Swelling (Grade 3: Pain:unable to perform usual activities \\[age 2-11 years\\], significant interference with daily activities \\[age \\>=12 years\\]; Erythema and Swelling \\>=50 mm \\[age 2-11 years\\], \\>100 mm \\[age \\>=12 years\\])\n2. Solicited systemic reactions:\n\n * Age 6-23 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability (Grade 3: Fever:\\>39.5 degree Celsius; Vomiting:\\>=6 episodes/24 hours; Crying abnormal:\\>3 hours; Drowsiness:sleeping most of the time or difficult to wake up; Appetite loss: refuses \\>=3 feeds/meals or most feeds/meals; Irritability: inconsolable)\n * Age \\>=2 years:Fever, Headache, Malaise, Myalgia and Shivering (Grade 3:Fever\\>=39.0 degree Celsius; Headache, Malaise, Myalgia and Shivering:significant interference in daily activities)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed using Safety Analysis Set which included all participants who received at least 1 dose of study vaccine. Here, 'Number Analyzed' = those participants with available data for specified categories. 'Number analyzed' = 0 signifies that reported reaction was not analyzed in the specified age group."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months', 'description': 'Participants aged 6 to 35 months received 2 doses of 0.25 mL Quadrivalent Influenza Vaccine (QIV) (2016-2017 Northern Hemisphere (NH) formulation) intramuscularly, 1 injection each at Day 0 and 28.'}, {'id': 'FG001', 'title': 'Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years', 'description': 'Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 Southern Hemisphere (SH) formulation) intramuscularly, 1 injection each at Day 0 and 28.'}, {'id': 'FG002', 'title': 'Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years', 'description': 'Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.'}, {'id': 'FG003', 'title': 'Quadrivalent Influenza Vaccine Group 4: >=18 Years', 'description': 'Participants aged \\>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '100'}, {'groupId': 'FG003', 'numSubjects': '100'}]}, {'type': 'Vaccinated at Day 0', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '100'}, {'groupId': 'FG003', 'numSubjects': '100'}]}, {'type': 'Vaccinated at Day 28', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'comment': 'Participants aged 9 years and older received only 1 dose of Quadrivalent Influenza Vaccine.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Participants aged 9 years and older received only 1 dose of Quadrivalent Influenza Vaccine.', 'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '99'}, {'groupId': 'FG003', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study participants were enrolled in 8 centers in India from 27 July 2015 to 26 November 2016.', 'preAssignmentDetails': 'A total of 400 participants (100 in each group) were enrolled and vaccinated in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}, {'value': '396', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months', 'description': 'Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.'}, {'id': 'BG001', 'title': 'Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years', 'description': 'Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.'}, {'id': 'BG002', 'title': 'Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years', 'description': 'Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.'}, {'id': 'BG003', 'title': 'Quadrivalent Influenza Vaccine Group 4: >=18 Years', 'description': 'Participants aged \\>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}, {'value': '396', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '4.9', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '11.7', 'spread': '2.2', 'groupId': 'BG002'}, {'value': '48.5', 'spread': '18.8', 'groupId': 'BG003'}, {'value': '16.6', 'spread': '21.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}, {'value': '396', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '189', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '207', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'India', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}, {'value': '396', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}, {'value': '396', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Analysis was performed using Full Analysis Set (FAS) which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-09-30', 'size': 2524733, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-01-29T04:13', 'hasProtocol': True}, {'date': '2016-03-04', 'size': 189495, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-01-29T04:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-27'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2017-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2015-05-14', 'resultsFirstSubmitDate': '2018-01-29', 'studyFirstSubmitQcDate': '2015-05-18', 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-29', 'studyFirstPostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies', 'timeFrame': 'Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)', 'description': 'Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.'}, {'measure': 'Number of Participants With Seroprotection to Influenza Vaccine Antigens', 'timeFrame': 'Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)', 'description': 'Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer \\>=40 (1/dilution\\[dil\\]) at pre-vaccination and at post-final vaccination.'}, {'measure': 'Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens', 'timeFrame': '28 days post-final vaccination (post-vaccination)', 'description': 'Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer \\<10 (1/dil) and post-vaccination titer \\>=40 (1/dil), and Significant increase was defined as pre-vaccination titer \\>=10 (1/dil) and \\>= 4-fold increase of post-vaccination titer.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine', 'timeFrame': 'Within 7 days after any vaccination', 'description': '1. Solicited injection site reactions:\n\n * Age 6-23 months: Tenderness, Erythema and Swelling(Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling:\\>=50 mm)\n * Age \\>=2 years: Pain, Erythema and Swelling (Grade 3: Pain:unable to perform usual activities \\[age 2-11 years\\], significant interference with daily activities \\[age \\>=12 years\\]; Erythema and Swelling \\>=50 mm \\[age 2-11 years\\], \\>100 mm \\[age \\>=12 years\\])\n2. Solicited systemic reactions:\n\n * Age 6-23 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability (Grade 3: Fever:\\>39.5 degree Celsius; Vomiting:\\>=6 episodes/24 hours; Crying abnormal:\\>3 hours; Drowsiness:sleeping most of the time or difficult to wake up; Appetite loss: refuses \\>=3 feeds/meals or most feeds/meals; Irritability: inconsolable)\n * Age \\>=2 years:Fever, Headache, Malaise, Myalgia and Shivering (Grade 3:Fever\\>=39.0 degree Celsius; Headache, Malaise, Myalgia and Shivering:significant interference in daily activities)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Influenza', 'Quadrivalent Inactivated Influenza Vaccine (QIV)'], 'conditions': ['Influenza']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study was to generate immunogenicity and safety data in the whole population to support registration of the Quadrivalent Influenza Vaccine (QIV) in India:\n\nPrimary objective:\n\n* To describe in each age group the immune response induced by a single injection (participants aged \\>9 years) or 2 injections (participants aged 6 months to 8 years) of QIV.\n\nSecondary objective:\n\n* To describe in each age group the safety profile of QIV.', 'detailedDescription': 'All participants were vaccinated with the QIV (split-virion, inactivated) Northern Hemisphere (NH) or Southern Hemisphere (SH) formulations by the intramuscular (IM) route. Immunogenicity of the vaccine was assessed at baseline (Day 0) and 28 days after the last injection. Safety data were collected up to 28 days after each injection. Serious adverse events (SAEs) were collected throughout the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 6 months or older on the day of inclusion\n* For participants aged 6 to 35 months only: born at full term of pregnancy (\\>=37 weeks) or birth weight \\>=2.5 kg or both\n* Informed consent form had been signed and dated by the participants / participants' parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations. For participants aged 7 to 17 years of age, assent form has been signed and dated by the participants\n* Participants / participants' parent/legally acceptable representative were able to attend all scheduled visits and to comply with all trial procedures\n\nExclusion Criteria:\n\n* For participants aged 9 years or older only: participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination)\n* Participation at the time of study enrollment (or in the 4 weeks 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 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination (except Oral Poliomyelitis Vaccine (OPV) received during national immunization days)\n* For participants aged 9 years or older only: previous vaccination against influenza (in the previous 9 months) with any influenza vaccine\n* For participants aged 6 months to 8 years only: previous priming with any influenza vaccine (i.e., participants who received 2 doses for at least 1 previous influenza season)\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* Self-reported history of seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, after questioning\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* Self-reported thrombocytopenia or as reported by the parent/legally acceptable representative, contraindicating intramuscular vaccination\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination\n* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily\n* For participants aged 9 years or older only: current alcohol abuse or drug addiction\n* Chronic illness that, in the opinion of the Investigator, was 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 vaccination or febrile illness (axillary temperature \\>=38.0 degree Celsius). A prospective participants should not be included in the study until the condition had resolved or the febrile event has subsided\n* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study"}, 'identificationModule': {'nctId': 'NCT02451358', 'briefTitle': 'Study of a Single Dose or Two Doses of a Quadrivalent Influenza Vaccine in Subjects Aged 6 Months or Older in India', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity and Safety of a Single Dose or Two Doses Given 28 Days Apart of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Subjects Aged 6 Months or Older in India', 'orgStudyIdInfo': {'id': 'QIV06'}, 'secondaryIdInfos': [{'id': 'U1111-1143-8370', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'CTRI/2015/05/005770', 'type': 'OTHER', 'domain': 'CTR-India'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months', 'description': 'Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.', 'interventionNames': ['Biological: Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative']}, {'type': 'EXPERIMENTAL', 'label': 'Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years', 'description': 'Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.', 'interventionNames': ['Biological: Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative']}, {'type': 'EXPERIMENTAL', 'label': 'Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years', 'description': 'Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.', 'interventionNames': ['Biological: Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative']}, {'type': 'EXPERIMENTAL', 'label': 'Quadrivalent Influenza Vaccine Group 4: >=18 Years', 'description': 'Participants aged \\>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.', 'interventionNames': ['Biological: Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No Preservative']}], 'interventions': [{'name': 'Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative', 'type': 'BIOLOGICAL', 'otherNames': ['QIV, No Preservative'], 'description': '0.25 mL, Intramuscular', 'armGroupLabels': ['Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months']}, {'name': 'Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative', 'type': 'BIOLOGICAL', 'otherNames': ['QIV, No Preservative'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years']}, {'name': 'Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative', 'type': 'BIOLOGICAL', 'otherNames': ['QIV, No Preservative'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years']}, {'name': 'Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No Preservative', 'type': 'BIOLOGICAL', 'otherNames': ['QIV, No Preservative'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Quadrivalent Influenza Vaccine Group 4: >=18 Years']}]}, 'contactsLocationsModule': {'locations': [{'zip': '390001', 'city': 'Vadodara', 'state': 'Gujarat', 'country': 'India', 'geoPoint': {'lat': 22.29941, 'lon': 73.20812}}, {'zip': '571401', 'city': 'Mandya', 'state': 'Karnataka', 'country': 'India', 'geoPoint': {'lat': 12.5223, 'lon': 76.89746}}, {'zip': '411043', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '400012', 'city': 'Mumbai', 'state': 'Parel', 'country': 'India', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '411018', 'city': 'Pimpri', 'state': 'Pune', 'country': 'India', 'geoPoint': {'lat': 18.62292, 'lon': 73.80696}}, {'zip': '141008', 'city': 'Ludhiana', 'state': 'Punjab', 'country': 'India', 'geoPoint': {'lat': 30.91204, 'lon': 75.85379}}, {'zip': '700017', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '560054', 'city': 'Bangalore', 'country': 'India', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur SA'}]}, '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'}}}}