Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-02 @ 3:48 PM
Study NCT ID:
NCT00980005
Status:
COMPLETED
Last Update Posted:
2018-09-21
First Post:
2009-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).', 'description': 'Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.', 'otherNumAtRisk': 1055, 'otherNumAffected': 742, 'seriousNumAtRisk': 1055, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.", 'otherNumAtRisk': 1061, 'otherNumAffected': 710, 'seriousNumAtRisk': 1061, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Cough', 'notes': 'Unsolicited AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 129}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 115}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'notes': 'Unsolicited AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 60}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'notes': 'Solicited general AE: Subjects of 5 years of age and above', 'stats': [{'groupId': 'EG000', 'numAtRisk': 750, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 747, 'numAffected': 80}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'Solicited general AE: Subjects of 5 years of age and above', 'stats': [{'groupId': 'EG000', 'numAtRisk': 750, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 747, 'numAffected': 137}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Solicited general AE: Subjects of 5 years of age and above', 'stats': [{'groupId': 'EG000', 'numAtRisk': 750, 'numAffected': 141}, {'groupId': 'EG001', 'numAtRisk': 747, 'numAffected': 131}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle aches', 'notes': 'Solicited general AE: Subjects of 5 years of age and above', 'stats': [{'groupId': 'EG000', 'numAtRisk': 750, 'numAffected': 200}, {'groupId': 'EG001', 'numAtRisk': 747, 'numAffected': 189}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shivering', 'notes': 'Solicited general AE: Subjects of 5 years of age and above', 'stats': [{'groupId': 'EG000', 'numAtRisk': 750, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 747, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsiness', 'notes': 'Solicited general AE: Subjects below 5 years of age', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 63}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'notes': 'Solicited general AE: Subjects below 5 years of age', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 87}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of appetite', 'notes': 'Solicited general AE: Subjects below 5 years of age', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Temperature', 'notes': 'Solicited general AE: Subjects below 5 years of age. Temperature = axillary temperature equal to or above 38.0 degrees Celsius (°C).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 279, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'Solicited local AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1043, 'numAffected': 615}, {'groupId': 'EG001', 'numAtRisk': 1026, 'numAffected': 584}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness', 'notes': 'Solicited local AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1043, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 1026, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'notes': 'Solicited local AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1043, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 1026, 'numAffected': 59}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpangina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Attention deficit/hyperactivity disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'H1N1 influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oppositional defiant disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1055, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1061, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '979', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}], 'classes': [{'title': 'A/Brisbane [at Day 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG000', 'lowerLimit': '41.9', 'upperLimit': '50.4'}, {'value': '45.8', 'groupId': 'OG001', 'lowerLimit': '41.8', 'upperLimit': '50.2'}]}]}, {'title': 'A/Brisbane [at Day 28]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '979', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '320.9', 'groupId': 'OG000', 'lowerLimit': '298.3', 'upperLimit': '345.2'}, {'value': '329.4', 'groupId': 'OG001', 'lowerLimit': '306.8', 'upperLimit': '353.7'}]}]}, {'title': 'A/Uruguay [at Day 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '63.0'}, {'value': '63.9', 'groupId': 'OG001', 'lowerLimit': '58.1', 'upperLimit': '70.3'}]}]}, {'title': 'A/Uruguay [at Day 28]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '979', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '414.7', 'groupId': 'OG000', 'lowerLimit': '386.5', 'upperLimit': '444.9'}, {'value': '451.9', 'groupId': 'OG001', 'lowerLimit': '423.8', 'upperLimit': '481.8'}]}]}, {'title': 'B/Brisbane [at Day 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '18.1'}, {'value': '16.8', 'groupId': 'OG001', 'lowerLimit': '15.4', 'upperLimit': '18.3'}]}]}, {'title': 'B/Brisbane [at Day 28]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '979', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '213.7', 'groupId': 'OG000', 'lowerLimit': '198.5', 'upperLimit': '230.1'}, {'value': '200.2', 'groupId': 'OG001', 'lowerLimit': '186.1', 'upperLimit': '215.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 0 and 28 after last vaccine dose.', 'description': 'The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.\n\nTiters were expressed as geometric mean antibody titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.'}, {'type': 'PRIMARY', 'title': 'Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}], 'classes': [{'title': 'A/Brisbane', 'categories': [{'measurements': [{'value': '590', 'groupId': 'OG000'}, {'value': '569', 'groupId': 'OG001'}]}]}, {'title': 'A/Uruguay', 'categories': [{'measurements': [{'value': '673', 'groupId': 'OG000'}, {'value': '647', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane', 'categories': [{'measurements': [{'value': '800', 'groupId': 'OG000'}, {'value': '769', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 28 after last vaccine dose.', 'description': 'The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.\n\nSeroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer \\< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '979', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}], 'classes': [{'title': 'A/Brisbane at Day 0 [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.4', 'groupId': 'OG000', 'lowerLimit': '31.5', 'upperLimit': '46.7'}, {'value': '34.4', 'groupId': 'OG001', 'lowerLimit': '28.4', 'upperLimit': '41.7'}]}]}, {'title': 'A/Brisbane at Day 28 [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '263.5', 'groupId': 'OG000', 'lowerLimit': '229.3', 'upperLimit': '302.9'}, {'value': '281.9', 'groupId': 'OG001', 'lowerLimit': '246.3', 'upperLimit': '322.7'}]}]}, {'title': 'A/Brisbane at Day 0 [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.2', 'groupId': 'OG000', 'lowerLimit': '34.8', 'upperLimit': '46.5'}, {'value': '41.4', 'groupId': 'OG001', 'lowerLimit': '35.7', 'upperLimit': '48.1'}]}]}, {'title': 'A/Brisbane at Day 28 [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '251.8', 'groupId': 'OG000', 'lowerLimit': '222.3', 'upperLimit': '285.3'}, {'value': '251.5', 'groupId': 'OG001', 'lowerLimit': '223.8', 'upperLimit': '282.7'}]}]}, {'title': 'A/Brisbane at Day 0 [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.2', 'groupId': 'OG000', 'lowerLimit': '52.0', 'upperLimit': '69.6'}, {'value': '61.9', 'groupId': 'OG001', 'lowerLimit': '53.7', 'upperLimit': '71.2'}]}]}, {'title': 'A/Brisbane at Day 28 [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '473.6', 'groupId': 'OG000', 'lowerLimit': '425.1', 'upperLimit': '527.5'}, {'value': '478.2', 'groupId': 'OG001', 'lowerLimit': '428.2', 'upperLimit': '534.0'}]}]}, {'title': 'A/Uruguay at Day 0 [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000', 'lowerLimit': '31.7', 'upperLimit': '47.2'}, {'value': '50.2', 'groupId': 'OG001', 'lowerLimit': '40.7', 'upperLimit': '61.8'}]}]}, {'title': 'A/Uruguay at Day 28 [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '322.8', 'groupId': 'OG000', 'lowerLimit': '276.9', 'upperLimit': '376.3'}, {'value': '418.3', 'groupId': 'OG001', 'lowerLimit': '366.9', 'upperLimit': '477.0'}]}]}, {'title': 'A/Uruguay at Day 0 [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.5', 'groupId': 'OG000', 'lowerLimit': '66.9', 'upperLimit': '92.1'}, {'value': '78.1', 'groupId': 'OG001', 'lowerLimit': '67.0', 'upperLimit': '91.2'}]}]}, {'title': 'A/Uruguay at Day 28 [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '476.3', 'groupId': 'OG000', 'lowerLimit': '426.3', 'upperLimit': '532.1'}, {'value': '494.2', 'groupId': 'OG001', 'lowerLimit': '442.4', 'upperLimit': '552.1'}]}]}, {'title': 'A/Uruguay at 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{'value': '354', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '196.8', 'groupId': 'OG000', 'lowerLimit': '175.1', 'upperLimit': '221.1'}, {'value': '202.8', 'groupId': 'OG001', 'lowerLimit': '179.0', 'upperLimit': '229.7'}]}]}, {'title': 'B/Brisbane at Day 0 [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '23.6'}, {'value': '21.7', 'groupId': 'OG001', 'lowerLimit': '18.9', 'upperLimit': '24.9'}]}]}, {'title': 'B/Brisbane at Day 28 [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '271.1', 'groupId': 'OG000', 'lowerLimit': '240.8', 'upperLimit': '305.1'}, {'value': '244.6', 'groupId': 'OG001', 'lowerLimit': '217.9', 'upperLimit': 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This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}], 'classes': [{'title': 'A/Brisbane [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}]}, {'title': 'A/Brisbane [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}]}, {'title': 'A/Brisbane [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}]}, {'title': 'A/Uruguay [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '203', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}]}, {'title': 'A/Uruguay [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}]}, {'title': 'A/Uruguay [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '237', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '289', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '284', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 28 after last vaccine dose.', 'description': 'The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.\n\nSeroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer \\< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.\n\nSubjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '979', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}], 'classes': [{'title': 'A/Brisbane [at Day 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '640', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}]}, {'title': 'A/Brisbane [at Day 28]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '979', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '969', 'groupId': 'OG000'}, {'value': '965', 'groupId': 'OG001'}]}]}, {'title': 'A/Uruguay [at Day 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '676', 'groupId': 'OG000'}, {'value': '690', 'groupId': 'OG001'}]}]}, {'title': 'A/Uruguay [at Day 28]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '979', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '970', 'groupId': 'OG000'}, {'value': '973', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane [at Day 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '359', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane [at Day 28]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '979', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '936', 'groupId': 'OG000'}, {'value': '925', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0 and 28 after last vaccine dose.', 'description': 'The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.\n\nSeroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '979', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}], 'classes': [{'title': 'A/Brisbane at Day 0 [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}]}, {'title': 'A/Brisbane at Day 28 [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '265', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}]}, {'title': 'A/Brisbane at Day 0 [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}]}, {'title': 'A/Brisbane at Day 28 [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '347', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}]}]}, {'title': 'A/Brisbane at Day 0 [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}]}, {'title': 'A/Brisbane at Day 28 [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '357', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}]}, {'title': 'A/Uruguay at Day 0 [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}]}, {'title': 'A/Uruguay at Day 28 [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '265', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}]}, {'title': 'A/Uruguay at Day 0 [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '267', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}]}, {'title': 'A/Uruguay at Day 28 [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '349', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}]}, {'title': 'A/Uruguay at Day 0 [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '256', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}]}, {'title': 'A/Uruguay at Day 28 [9-17 years] )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '356', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane at Day 0 [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane at Day 28 [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane at Day 0 [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane at Day 28 [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '334', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane at Day 0 [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane at Day 28 [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '348', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0 and 28 after last vaccine dose.', 'description': 'The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.\n\nSeroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.\n\nSubjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.'}, {'type': 'SECONDARY', 'title': 'Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}], 'classes': [{'title': 'A/Brisbane', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '7.7'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '8.0'}]}]}, {'title': 'A/Uruguay', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '7.9'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '7.7'}]}]}, {'title': 'B/Brisbane', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '14.0'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': '13.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 0 and at Day 28 after last vaccine dose', 'description': 'The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.\n\nSeroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.\n\nSeroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.', 'unitOfMeasure': 'Fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.'}, {'type': 'SECONDARY', 'title': 'Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}], 'classes': [{'title': 'A/Brisbane [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '9.8'}]}]}, {'title': 'A/Brisbane [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '7.3'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '7.1'}]}]}, {'title': 'A/Brisbane [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '9.3'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '9.2'}]}]}, {'title': 'A/Uruguay [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '9.7'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '9.9'}]}]}, {'title': 'A/Uruguay [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '6.9'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '7.2'}]}]}, {'title': 'A/Uruguay [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '9.0'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '8.2'}]}]}, {'title': 'B/Brisbane [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000', 'lowerLimit': '11.5', 'upperLimit': '15.4'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '14.8'}]}]}, {'title': 'B/Brisbane [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '13.8'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '10.5', 'upperLimit': '13.7'}]}]}, {'title': 'B/Brisbane [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '15.4'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '9.6', 'upperLimit': '13.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 0 and at Day 28 after last vaccine dose', 'description': 'The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.\n\nSeroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.\n\nSeroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.\n\nSubjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.', 'unitOfMeasure': 'Fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '293', 'groupId': 'OG002'}, {'value': '279', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}, {'id': 'OG002', 'title': 'Flulaval Less Than 5 Years Old Group', 'description': 'Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.'}, {'id': 'OG003', 'title': 'Fluzone Les Than 5 Years Old Group', 'description': "Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age"}], 'classes': [{'title': 'Any drowsiness', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 drowsiness', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Drowsiness related to vaccination', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}]}, {'title': 'Any irritability', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 irritability', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Irritability related to vaccination', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}]}, {'title': 'Any loss of appetite', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 loss of appetite', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Loss of appetite related to vaccination', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}]}, {'title': 'Fever >= 38.0°C', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Fever >= 39.0°C - <= 40.0°C', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Fever related to vaccination', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During a 4-day follow-up period (Days 0-3) after vaccination.', 'description': 'The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).\n\nAny = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.\n\nGrade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all.\n\nGrade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.\n\nRelated = symptom assessed by the investigator as causally related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '750', 'groupId': 'OG002'}, {'value': '747', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}, {'id': 'OG002', 'title': 'Flulaval 5 Years of Age and Older Group', 'description': 'Subjects aged 5 years and above and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.'}, {'id': 'OG003', 'title': 'Fluzone 5 Years of Age and Older Group', 'description': "Subjects aged 5 years and above and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age"}], 'classes': [{'title': 'Any arthralgia', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 arthralgia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Arthralgia related to vaccination', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}]}, {'title': 'Any fatigue', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 fatigue', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue related to vaccination', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}]}, {'title': 'Any headache', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 headache', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Headache related to vaccination', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}]}]}, {'title': 'Any muscle aches', 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG002'}, {'value': '189', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 muscle aches', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Muscle aches related to vaccination', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}]}, {'title': 'Any shivering', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 shivering', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Shivering related to vaccination', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}]}, {'title': 'Fever >= 38.0°C', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}]}, {'title': 'Fever >= 39.0°C - <= 40.0°C', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Temperature related to vaccination', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During a 4-day follow-up period (Days 0-3) after vaccination.', 'description': 'The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).\n\nAny = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.\n\nGrade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.\n\nRelated = symptom assessed by the investigator as causaly related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1043', 'groupId': 'OG000'}, {'value': '1026', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}], 'classes': [{'title': 'Any pain', 'categories': [{'measurements': [{'value': '615', 'groupId': 'OG000'}, {'value': '584', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 pain', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Any redness', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 redness', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any swelling', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 swelling', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During a 4-day follow-up period (Days 0-3) after vaccination.', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade.\n\nGrade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1043', 'groupId': 'OG000'}, {'value': '1026', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}], 'classes': [{'title': 'Any pain [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 pain [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any redness [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 redness [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any swelling [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 swelling [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any pain [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '252', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 pain [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Any redness [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 redness [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any swelling [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 swelling [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any pain [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 pain [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any redness [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 redness [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any swelling [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 swelling [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During a 4-day follow-up period (Days 0-3) after vaccination.', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade.\n\nGrade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1055', 'groupId': 'OG000'}, {'value': '1061', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}], 'classes': [{'title': 'Any AE(s)', 'categories': [{'measurements': [{'value': '421', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 AE(s)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'Related AE(s)', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During a 28 day follow-up period (Days 0-27) after vaccination.', 'description': "Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.\n\nGrade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1055', 'groupId': 'OG000'}, {'value': '1061', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}], 'classes': [{'title': 'Any AE(s) [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 AE(s) [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Related AE(s) [3-4 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Any AE(s) [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 AE(s) [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Related AE(s) [5-8 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Any AE(s) [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 AE(s) [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Related AE(s) [9-17 years]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During a 28 day follow-up period (Days 0-27) after vaccination.', 'description': "Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.\n\nSubjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.\n\nGrade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Medically Attended Adverse Events (MAEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1055', 'groupId': 'OG000'}, {'value': '1061', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}], 'classes': [{'categories': [{'measurements': [{'value': '447', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (From Day 0 up to Day 180).', 'description': "For each solicited and unsolicited symptom the subject experiences, the subject/subject's parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Serious Adverse Events (SAEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1055', 'groupId': 'OG000'}, {'value': '1061', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (From Day 0 up to Day 180).', 'description': 'An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all vaccinated subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'FG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1055'}, {'groupId': 'FG001', 'numSubjects': '1061'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1008'}, {'groupId': 'FG001', 'numSubjects': '998'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '63'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Subjects were stratified by age-strata: 3-4, 5-8 and 9-17 years and received vaccine according to their priming status: primed subjects received a 2-dose priming immunization in a previous season, whereas unprimed subjects had not. Blood samples: at Days 0 - 28 for primed subjects and subjects 9-17 years and at Days 0-56 for unprimed subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1055', 'groupId': 'BG000'}, {'value': '1061', 'groupId': 'BG001'}, {'value': '2116', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.'}, {'id': 'BG001', 'title': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '4.18', 'groupId': 'BG000'}, {'value': '7.8', 'spread': '4.10', 'groupId': 'BG001'}, {'value': '7.8', 'spread': '4.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '500', 'groupId': 'BG000'}, {'value': '496', 'groupId': 'BG001'}, {'value': '996', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '555', 'groupId': 'BG000'}, {'value': '565', 'groupId': 'BG001'}, {'value': '1120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10-13'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2010-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-22', 'studyFirstSubmitDate': '2009-09-17', 'resultsFirstSubmitDate': '2012-01-20', 'studyFirstSubmitQcDate': '2009-09-17', 'lastUpdatePostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-01-26', 'studyFirstPostDateStruct': {'date': '2009-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.', 'timeFrame': 'At Day 0 and 28 after last vaccine dose.', 'description': 'The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.\n\nTiters were expressed as geometric mean antibody titers (GMTs).'}, {'measure': 'Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.', 'timeFrame': 'At Day 28 after last vaccine dose.', 'description': 'The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.\n\nSeroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer \\< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.', 'timeFrame': 'At Day 0 and 28 after last vaccine dose.', 'description': 'The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.\n\nTiters were expressed as geometric mean antibody titers (GMTs).\n\nSubjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.'}, {'measure': 'Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.', 'timeFrame': 'At Day 28 after last vaccine dose.', 'description': 'The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.\n\nSeroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer \\< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.\n\nSubjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.'}, {'measure': 'Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.', 'timeFrame': 'At Day 0 and 28 after last vaccine dose.', 'description': 'The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.\n\nSeroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.'}, {'measure': 'Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.', 'timeFrame': 'At Day 0 and 28 after last vaccine dose.', 'description': 'The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.\n\nSeroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.\n\nSubjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.'}, {'measure': 'Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.', 'timeFrame': 'At Day 0 and at Day 28 after last vaccine dose', 'description': 'The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.\n\nSeroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.\n\nSeroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.'}, {'measure': 'Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.', 'timeFrame': 'At Day 0 and at Day 28 after last vaccine dose', 'description': 'The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.\n\nSeroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.\n\nSeroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.\n\nSubjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.'}, {'measure': 'Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).', 'timeFrame': 'During a 4-day follow-up period (Days 0-3) after vaccination.', 'description': 'The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).\n\nAny = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.\n\nGrade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all.\n\nGrade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.\n\nRelated = symptom assessed by the investigator as causally related to the vaccination.'}, {'measure': 'Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).', 'timeFrame': 'During a 4-day follow-up period (Days 0-3) after vaccination.', 'description': 'The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).\n\nAny = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.\n\nGrade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.\n\nRelated = symptom assessed by the investigator as causaly related to the vaccination.'}, {'measure': 'Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).', 'timeFrame': 'During a 4-day follow-up period (Days 0-3) after vaccination.', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade.\n\nGrade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination.'}, {'measure': 'Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.', 'timeFrame': 'During a 4-day follow-up period (Days 0-3) after vaccination.', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade.\n\nGrade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.'}, {'measure': 'Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).', 'timeFrame': 'During a 28 day follow-up period (Days 0-27) after vaccination.', 'description': "Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.\n\nGrade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination."}, {'measure': 'Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.', 'timeFrame': 'During a 28 day follow-up period (Days 0-27) after vaccination.', 'description': "Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.\n\nSubjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.\n\nGrade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination."}, {'measure': 'Number of Subjects Reporting Medically Attended Adverse Events (MAEs).', 'timeFrame': 'During the entire study period (From Day 0 up to Day 180).', 'description': "For each solicited and unsolicited symptom the subject experiences, the subject/subject's parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason."}, {'measure': 'Number of Subjects Reporting Serious Adverse Events (SAEs).', 'timeFrame': 'During the entire study period (From Day 0 up to Day 180).', 'description': 'An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.'}]}, 'conditionsModule': {'keywords': ['GSK Biologicals influenza vaccine GSK1557482A', 'influenza infection'], 'conditions': ['Influenza']}, 'referencesModule': {'availIpds': [{'id': '112999', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112999', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112999', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112999', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112999', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112999', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112999', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '29465480', 'type': 'DERIVED', 'citation': 'Li-Kim-Moy J, Wood N, Jones C, Macartney K, Booy R. Impact of Fever and Antipyretic Use on Influenza Vaccine Immune Reponses in Children. Pediatr Infect Dis J. 2018 Oct;37(10):971-975. doi: 10.1097/INF.0000000000001949.'}, {'pmid': '22333695', 'type': 'DERIVED', 'citation': 'Domachowske JB, Blatter M, Chandrasekaran V, Liu A, Jain VK, Fries L. A randomized, controlled trial in children to assess the immunogenicity and safety of a thimerosal-free trivalent seasonal influenza vaccine. Pediatr Infect Dis J. 2012 Jun;31(6):605-15. doi: 10.1097/INF.0b013e31824e2924.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': "The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the investigator believes can and will comply with the requirements of the protocol.\n* A male or female child aged between 3 years and 17 years of age at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.\n* Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.\n* Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.\n* Female subjects of non-childbearing potential may be enrolled in the study.\n* Female subjects of childbearing potential may be enrolled in the study, if the subject:\n* has practiced adequate contraception for 30 days prior to vaccination, and\n* has a negative pregnancy test on the day of vaccination, and\n* has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations or registered and recommended pandemic influenza vaccine are not an exclusion.\n* Receipt of a seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.\n* Child in care\n* Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.\n* History of hypersensitivity to any vaccine.\n* History of Guillain-Barré-syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).\n* Acute disease and/or fever at the time of enrolment.\n* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.\n* Pregnant or lactating female.\n* History of chronic alcohol consumption and/or drug abuse.\n* Female planning to become pregnant or planning to discontinue contraceptive precautions.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.'}, 'identificationModule': {'nctId': 'NCT00980005', 'briefTitle': 'Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Immunogenicity & Safety Study of GSK Biologicals' Thimerosal-free Trivalent Influenza Vaccine (TIV) Versus a Licensed Comparator in Children", 'orgStudyIdInfo': {'id': '112999'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flulaval Group', 'description': 'subjects received Flulaval™ vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.', 'interventionNames': ['Biological: GSK investigational vaccine GSK1557482A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluzone Group', 'description': "subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:\n\n* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28\n* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.", 'interventionNames': ['Biological: Fluzone®']}], 'interventions': [{'name': 'GSK investigational vaccine GSK1557482A', 'type': 'BIOLOGICAL', 'description': 'One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects', 'armGroupLabels': ['Flulaval Group']}, {'name': 'Fluzone®', 'type': 'BIOLOGICAL', 'description': 'One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects', 'armGroupLabels': ['Fluzone Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 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