Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 1:39 PM
Study NCT ID:
NCT01218308
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2010-10-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy of GSK Biologicals' 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': 'D022362', 'term': 'Hepatitis A Vaccines'}], 'ancestors': [{'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}, {'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': 'SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination.', 'description': 'For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.', 'eventGroups': [{'id': 'EG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.', 'otherNumAtRisk': 2584, 'otherNumAffected': 1215, 'seriousNumAtRisk': 2584, 'seriousNumAffected': 36}, {'id': 'EG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.', 'otherNumAtRisk': 2584, 'otherNumAffected': 1297, 'seriousNumAtRisk': 2584, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 213}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 231}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 145}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 137}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2546, 'numAffected': 1215}, {'groupId': 'EG001', 'numAtRisk': 2551, 'numAffected': 888}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsiness', 'notes': 'Symptom reported for subjects below 5 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 899, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 896, 'numAffected': 93}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'notes': 'Symptom reported for subjects below 5 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 899, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 896, 'numAffected': 91}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of appetite', 'notes': 'Symptom reported for subjects below 5 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 899, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 896, 'numAffected': 120}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Temperature', 'notes': 'Symptom reported for subjects below 5 years of age.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 899, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 896, 'numAffected': 74}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'Symptom reported for subjects of 5 years of age and above', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1648, 'numAffected': 188}, {'groupId': 'EG001', 'numAtRisk': 1654, 'numAffected': 145}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastro.', 'notes': 'Symptom reported for subjects of 5 years of age and above', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1648, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 1654, 'numAffected': 146}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Symptom reported for subjects of 5 years of age and above', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1648, 'numAffected': 243}, {'groupId': 'EG001', 'numAtRisk': 1654, 'numAffected': 217}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint pain', 'notes': 'Symptom reported for subjects of 5 years of age and above', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1648, 'numAffected': 143}, {'groupId': 'EG001', 'numAtRisk': 1654, 'numAffected': 93}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle aches', 'notes': 'Symptom reported for subjects of 5 years of age and above', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1648, 'numAffected': 257}, {'groupId': 'EG001', 'numAtRisk': 1654, 'numAffected': 194}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Amoebiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Amoebic dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Animal scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchial obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpangina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Optic nerve glioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Visceral leishmaniasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2584, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2584, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2379', 'groupId': 'OG000'}, {'value': '2398', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 14 to Day 180', 'description': 'To confirm influenza A and/or B disease, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for efficacy - Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2379', 'groupId': 'OG000'}, {'value': '2398', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 14 to Day 180', 'description': 'To confirm influenza A and/or B disease moderate to severe cases, a positive RT-PCR result for influenza A or B virus from a nose and throat swab obtained concurrently with an ILI was required. Moderate to severe influenza was defined as RT-PCR-confirmed ILI with:\n\n* Fever \\>39°C, and/or at least one of the following manifestations,\n* Physician-verified shortness of breath, pulmonary congestion, pneumonia, bronchiolitis, bronchitis, wheezing, croup, or acute otitis media, and/or one of the following,\n* Physician-diagnosed serious extra-pulmonary complication of influenza, including myositis, encephalitis, seizure, or myocarditis', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for efficacy - Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2379', 'groupId': 'OG000'}, {'value': '2398', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 14 to Day 180', 'description': 'To confirm influenza A and/or B disease due to antigenically matched strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for efficacy - Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2379', 'groupId': 'OG000'}, {'value': '2398', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 14 to Day 180', 'description': 'To confirm influenza A and/or B disease due to any strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for efficacy - Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.'}, {'type': 'SECONDARY', 'title': 'Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'H1N1, PRE [N=457;117]', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000', 'lowerLimit': '13.6', 'upperLimit': '17.3'}, {'value': '16.1', 'groupId': 'OG001', 'lowerLimit': '12.6', 'upperLimit': '20.5'}]}]}, {'title': 'H1N1, POST [N=457;121]', 'categories': [{'measurements': [{'value': '318.8', 'groupId': 'OG000', 'lowerLimit': '291.0', 'upperLimit': '349.2'}, {'value': '16.1', 'groupId': 'OG001', 'lowerLimit': '12.8', 'upperLimit': '20.2'}]}]}, {'title': 'H3N2, PRE [N=457;117]', 'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000', 'lowerLimit': '21.9', 'upperLimit': '27.0'}, {'value': '28.6', 'groupId': 'OG001', 'lowerLimit': '23.5', 'upperLimit': '34.8'}]}]}, {'title': 'H3N2, POST [N=457;122]', 'categories': [{'measurements': [{'value': '264.7', 'groupId': 'OG000', 'lowerLimit': '244.3', 'upperLimit': '286.8'}, {'value': '30.3', 'groupId': 'OG001', 'lowerLimit': '24.8', 'upperLimit': '36.9'}]}]}, {'title': 'Victoria, PRE [N=457;117]', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '12.2', 'upperLimit': '15.4'}, {'value': '15.6', 'groupId': 'OG001', 'lowerLimit': '12.2', 'upperLimit': '20.1'}]}]}, {'title': 'Victoria, POST [N=457;120]', 'categories': [{'measurements': [{'value': '239.9', 'groupId': 'OG000', 'lowerLimit': '214.6', 'upperLimit': '268.2'}, {'value': '17.8', 'groupId': 'OG001', 'lowerLimit': '13.7', 'upperLimit': '23.1'}]}]}, {'title': 'Yamagata, PRE [N=457;117]', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000', 'lowerLimit': '14.3', 'upperLimit': '18.4'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '14.4', 'upperLimit': '24.5'}]}]}, {'title': 'Yamagata, POST [N=457;117]', 'categories': [{'measurements': [{'value': '361.5', 'groupId': 'OG000', 'lowerLimit': '330.7', 'upperLimit': '395.3'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '14.9', 'upperLimit': '24.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]', 'description': 'Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'H1N1, POST', 'categories': [{'measurements': [{'value': '438', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'H3N2, POST', 'categories': [{'measurements': [{'value': '385', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Victoria, POST', 'categories': [{'measurements': [{'value': '425', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Yamagata, POST', 'categories': [{'measurements': [{'value': '435', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]', 'description': 'A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination 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. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'H1N1, PRE [N=457;117]', 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'H1N1, POST [N=457;121]', 'categories': [{'measurements': [{'value': '451', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'H3N2, PRE [N=457;117]', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'H3N2, POST [N=457;122]', 'categories': [{'measurements': [{'value': '445', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Victoria, PRE [N=457;117]', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Victoria, POST [N=457;120]', 'categories': [{'measurements': [{'value': '443', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Yamagata, PRE [N=457;117]', 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Yamagata, POST [N=457;117]', 'categories': [{'measurements': [{'value': '452', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]', 'description': 'A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.'}, {'type': 'SECONDARY', 'title': 'Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'H1N1, POST', 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '19.0', 'upperLimit': '22.8'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.1'}]}]}, {'title': 'H3N2, POST', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '12.1'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.2'}]}]}, {'title': 'Victoria, POST', 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '19.1'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.3'}]}]}, {'title': 'Yamagata, POST', 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000', 'lowerLimit': '20.1', 'upperLimit': '24.8'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]', 'description': 'The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).', 'unitOfMeasure': 'fold increase', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.'}, {'type': 'SECONDARY', 'title': 'Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'H1N1, PRE [N=444;112]', 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '17.6'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '21.2'}]}]}, {'title': 'H1N1, POST [N=444;112]', 'categories': [{'measurements': [{'value': '138.6', 'groupId': 'OG000', 'lowerLimit': '122.6', 'upperLimit': '156.6'}, {'value': '23.2', 'groupId': 'OG001', 'lowerLimit': '17.9', 'upperLimit': '30.1'}]}]}, {'title': 'H3N2, PRE [N=444;112]', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000', 'lowerLimit': '22.1', 'upperLimit': '27.4'}, {'value': '29.1', 'groupId': 'OG001', 'lowerLimit': '23.8', 'upperLimit': '35.5'}]}]}, {'title': 'H3N2, POST [N=443;112]', 'categories': [{'measurements': [{'value': '136.5', 'groupId': 'OG000', 'lowerLimit': '124.3', 'upperLimit': '149.9'}, {'value': '43.6', 'groupId': 'OG001', 'lowerLimit': '34.9', 'upperLimit': '54.5'}]}]}, {'title': 'Victoria, PRE [N=444;112]', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '12.2', 'upperLimit': '15.4'}, {'value': '15.1', 'groupId': 'OG001', 'lowerLimit': '11.8', 'upperLimit': '19.5'}]}]}, {'title': 'Victoria, POST [N=443;112]', 'categories': [{'measurements': [{'value': '110.2', 'groupId': 'OG000', 'lowerLimit': '97.1', 'upperLimit': '125.0'}, {'value': '19.7', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '25.8'}]}]}, {'title': 'Yamagata, PRE [N=444;112]', 'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '18.4'}, {'value': '18.7', 'groupId': 'OG001', 'lowerLimit': '14.3', 'upperLimit': '24.6'}]}]}, {'title': 'Yamagata, POST [N=444;112]', 'categories': [{'measurements': [{'value': '157.0', 'groupId': 'OG000', 'lowerLimit': '143.1', 'upperLimit': '172.3'}, {'value': '21.8', 'groupId': 'OG001', 'lowerLimit': '16.5', 'upperLimit': '28.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 0 and at least 6 months after first vaccination (Month 6)', 'description': 'HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Victoria/210/09 (H3N2), Flu B/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'H1N1, POST [N=444;112]', 'categories': [{'measurements': [{'value': '349', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'H3N2, POST [N=443;112]', 'categories': [{'measurements': [{'value': '290', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Victoria, POST [N=443;112]', 'categories': [{'measurements': [{'value': '323', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Yamagata, POST [N=444;112]', 'categories': [{'measurements': [{'value': '354', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At least 6 months after first vaccination (Month 6)', 'description': 'A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'H1N1, PRE [N=444;112]', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'H1N1, POST [N=444;112]', 'categories': [{'measurements': [{'value': '383', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'H3N2, PRE [N=444;112]', 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'H3N2, POST [N=443;112]', 'categories': [{'measurements': [{'value': '412', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Victoria, PRE [N=444;112]', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Victoria, POST [N=443;112]', 'categories': [{'measurements': [{'value': '374', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Yamagata, PRE [N=444;112]', 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Yamagata, POST [N=444;112]', 'categories': [{'measurements': [{'value': '427', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 0 and at least 6 months after first vaccination (Month 6)', 'description': 'A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Seroconversion Factors for HI Antibodies Against 4 Strains of Influenza Disease.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'H1N1, POST [N=444;112]', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '9.8'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '1.6'}]}]}, {'title': 'H3N2, POST [N=443;112]', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '6.1'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '1.8'}]}]}, {'title': 'Victoria, POST [N=443;112', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '8.9'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.6'}]}]}, {'title': 'Yamagata, POST [N=444;112]', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '10.8'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At least 6 months after first vaccination (Month 6)', 'description': 'Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).', 'unitOfMeasure': 'Fold increase', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2546', 'groupId': 'OG000'}, {'value': '2551', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '1215', 'groupId': 'OG000'}, {'value': '888', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 7-day (Days 0-6) follow-up period after any vaccination', 'description': 'Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = Incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful for subjects \\< 5 years of age or significant pain at rest that prevented normal, everyday activities for subjects ≥ 5 years of age. Grade 3 redness/swelling = Redness/swelling above 100 millimeters (mm) of the injection site. All solicited local symptoms were considered related to vaccination.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '899', 'groupId': 'OG000'}, {'value': '896', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Related Drowsiness', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Related Irritability', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of appetite', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Loss of appetite', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Related Loss of appetite', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Any Temperature', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Temperature', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Related Temperature', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 7-day (Days 0-6) follow-up period after any vaccination', 'description': 'Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature. Any = Occurrence of any solicited general symptom regardless of intensity grade and relation to vaccination. Any temperature = Axillary temperature ≥ 38.0 °C. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = not eating at all. Related = General symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = Axillary temperature ≥ 39.0°C.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1648', 'groupId': 'OG000'}, {'value': '1654', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Any Fatigue', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastro.', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastro.', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastro.', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}]}, {'title': 'Any Joint pain', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Joint pain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Joint pain', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Any Muscle aches', 'categories': [{'measurements': [{'value': '257', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Muscle aches', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Related Muscle aches', 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}, {'title': 'Any Shivering', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Shivering', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Shivering', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Any Temperature', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Temperature', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Related Temperature', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 7-day (Days 0-6) follow-up period after any vaccination', 'description': 'Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastro.), headache, joint pain at other location (Joint pain), muscle aches, shivering and temperature. Any = Occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Any temperature = Axillary temperature ≥ 38.0 °C. Grade 3 symptom = Symptom that prevented normal activity. Related = Symptom assessed by the investigator as causally related to the vaccination. Grade 3 temperature = Axillary temperature ≥ 39.0°C.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2584', 'groupId': 'OG000'}, {'value': '2584', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Any unsolicited AE(s)', 'categories': [{'measurements': [{'value': '843', 'groupId': 'OG000'}, {'value': '855', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 unsolicited AE(s)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Related unsolicited AE(s)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 28-day (Days 0-27) follow-up period after vaccination', 'description': 'Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Related Medically Attended Adverse Events (MAEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2584', 'groupId': 'OG000'}, {'value': '2584', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Any MAE(s)', 'categories': [{'measurements': [{'value': '792', 'groupId': 'OG000'}, {'value': '749', 'groupId': 'OG001'}]}]}, {'title': 'Related MAE(s)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the entire study period (Day 0 - Day 180)', 'description': 'MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = Any MAE regardless of intensity or relationship to vaccination. Related = MAE assessed by the investigator as causally related to the vaccination.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2584', 'groupId': 'OG000'}, {'value': '2584', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Any pIMD(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related pIMD(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the entire study period (Day 0 - Day 180)', 'description': 'pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any = Any pIMD(s) regardless of intensity or relationship to vaccination. Related = pIMDs assessed by the investigator as causally related to the vaccination.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Related Serious Adverse Events (SAEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2584', 'groupId': 'OG000'}, {'value': '2584', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Any SAE(s)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Related SAE(s)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the entire study period (Day 0 - Day 180)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Any SAE(s) regardless of intensity or relationship to vaccination. Related = SAEs assessed by the investigator as causally related to the vaccination.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'FG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2584'}, {'groupId': 'FG001', 'numSubjects': '2584'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2481'}, {'groupId': 'FG001', 'numSubjects': '2464'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '120'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '21'}]}]}], 'recruitmentDetails': 'A total of 5168 subjects have been enrolled in this study. Primed subjects had received at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine and had received 2 doses of seasonal influenza vaccine. Unprimed subjects had not received any influenza A (H1N1) 2009 monovalent vaccine or seasonal influenza vaccine.', 'preAssignmentDetails': 'The duration of the study was approximately 4-8 weeks to complete enrolment, with at least six months extended safety follow-up (ESFU) after first vaccination, and lasted until the end of the influenza like illness (ILI) surveillance period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2584', 'groupId': 'BG000'}, {'value': '2584', 'groupId': 'BG001'}, {'value': '5168', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'BG001', 'title': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '1.66', 'groupId': 'BG000'}, {'value': '5.4', 'spread': '1.65', 'groupId': 'BG001'}, {'value': '5.4', 'spread': '1.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1251', 'groupId': 'BG000'}, {'value': '1245', 'groupId': 'BG001'}, {'value': '2496', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1333', 'groupId': 'BG000'}, {'value': '1339', 'groupId': 'BG001'}, {'value': '2672', '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': 5220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'dispFirstSubmitDate': '2012-07-26', 'completionDateStruct': {'date': '2012-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-04', 'studyFirstSubmitDate': '2010-10-07', 'dispFirstSubmitQcDate': '2012-07-26', 'resultsFirstSubmitDate': '2013-02-21', 'studyFirstSubmitQcDate': '2010-10-07', 'dispFirstPostDateStruct': {'date': '2012-08-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-02-21', 'studyFirstPostDateStruct': {'date': '2010-10-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B.', 'timeFrame': 'From Day 14 to Day 180', 'description': 'To confirm influenza A and/or B disease, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B.', 'timeFrame': 'From Day 14 to Day 180', 'description': 'To confirm influenza A and/or B disease moderate to severe cases, a positive RT-PCR result for influenza A or B virus from a nose and throat swab obtained concurrently with an ILI was required. Moderate to severe influenza was defined as RT-PCR-confirmed ILI with:\n\n* Fever \\>39°C, and/or at least one of the following manifestations,\n* Physician-verified shortness of breath, pulmonary congestion, pneumonia, bronchiolitis, bronchitis, wheezing, croup, or acute otitis media, and/or one of the following,\n* Physician-diagnosed serious extra-pulmonary complication of influenza, including myositis, encephalitis, seizure, or myocarditis'}, {'measure': 'Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain.', 'timeFrame': 'From Day 14 to Day 180', 'description': 'To confirm influenza A and/or B disease due to antigenically matched strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.'}, {'measure': 'Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain.', 'timeFrame': 'From Day 14 to Day 180', 'description': 'To confirm influenza A and/or B disease due to any strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.'}, {'measure': 'Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.', 'timeFrame': 'At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]', 'description': 'Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).'}, {'measure': 'Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.', 'timeFrame': 'At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]', 'description': 'A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination 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. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).'}, {'measure': 'Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.', 'timeFrame': 'At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]', 'description': 'A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).'}, {'measure': 'Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.', 'timeFrame': 'At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]', 'description': 'The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).'}, {'measure': 'Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains', 'timeFrame': 'On Day 0 and at least 6 months after first vaccination (Month 6)', 'description': 'HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Victoria/210/09 (H3N2), Flu B/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).'}, {'measure': 'Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.', 'timeFrame': 'At least 6 months after first vaccination (Month 6)', 'description': 'A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).'}, {'measure': 'Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.', 'timeFrame': 'At Day 0 and at least 6 months after first vaccination (Month 6)', 'description': 'A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).'}, {'measure': 'Seroconversion Factors for HI Antibodies Against 4 Strains of Influenza Disease.', 'timeFrame': 'At least 6 months after first vaccination (Month 6)', 'description': 'Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.', 'timeFrame': 'During the 7-day (Days 0-6) follow-up period after any vaccination', 'description': 'Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = Incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful for subjects \\< 5 years of age or significant pain at rest that prevented normal, everyday activities for subjects ≥ 5 years of age. Grade 3 redness/swelling = Redness/swelling above 100 millimeters (mm) of the injection site. All solicited local symptoms were considered related to vaccination.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age.', 'timeFrame': 'During the 7-day (Days 0-6) follow-up period after any vaccination', 'description': 'Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature. Any = Occurrence of any solicited general symptom regardless of intensity grade and relation to vaccination. Any temperature = Axillary temperature ≥ 38.0 °C. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = not eating at all. Related = General symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = Axillary temperature ≥ 39.0°C.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above.', 'timeFrame': 'During the 7-day (Days 0-6) follow-up period after any vaccination', 'description': 'Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastro.), headache, joint pain at other location (Joint pain), muscle aches, shivering and temperature. Any = Occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Any temperature = Axillary temperature ≥ 38.0 °C. Grade 3 symptom = Symptom that prevented normal activity. Related = Symptom assessed by the investigator as causally related to the vaccination. Grade 3 temperature = Axillary temperature ≥ 39.0°C.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).', 'timeFrame': 'During the 28-day (Days 0-27) follow-up period after vaccination', 'description': 'Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.'}, {'measure': 'Number of Subjects With Any and Related Medically Attended Adverse Events (MAEs).', 'timeFrame': 'During the entire study period (Day 0 - Day 180)', 'description': 'MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = Any MAE regardless of intensity or relationship to vaccination. Related = MAE assessed by the investigator as causally related to the vaccination.'}, {'measure': 'Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs).', 'timeFrame': 'During the entire study period (Day 0 - Day 180)', 'description': 'pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any = Any pIMD(s) regardless of intensity or relationship to vaccination. Related = pIMDs assessed by the investigator as causally related to the vaccination.'}, {'measure': 'Number of Subjects With Any and Related Serious Adverse Events (SAEs).', 'timeFrame': 'During the entire study period (Day 0 - Day 180)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Any SAE(s) regardless of intensity or relationship to vaccination. Related = SAEs assessed by the investigator as causally related to the vaccination.'}]}, 'conditionsModule': {'keywords': ['Influenza'], 'conditions': ['Influenza']}, 'referencesModule': {'availIpds': [{'id': '114541', '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'}, {'id': '114541', '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': '114541', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '114541', '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': '114541', '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': '114541', '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': '114541', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '24328444', 'type': 'DERIVED', 'citation': 'Jain VK, Rivera L, Zaman K, Espos RA Jr, Sirivichayakul C, Quiambao BP, Rivera-Medina DM, Kerdpanich P, Ceyhan M, Dinleyici EC, Cravioto A, Yunus M, Chanthavanich P, Limkittikul K, Kurugol Z, Alhan E, Caplanusi A, Durviaux S, Boutet P, Ofori-Anyinam O, Chandrasekaran V, Dbaibo G, Innis BL. Vaccine for prevention of mild and moderate-to-severe influenza in children. N Engl J Med. 2013 Dec 26;369(26):2481-91. doi: 10.1056/NEJMoa1215817. Epub 2013 Dec 11.'}], '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': 'This study is designed to test the efficacy of an investigational influenza vaccine, in children compared to Havrix®, a licensed Hepatitis A virus vaccine.\n\nThis study will also evaluate the immunogenicity and safety of the investigational vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who the investigator believes that they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol.\n* A male or female child aged between 3 and 8 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season. However, subjects who have received any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine will not be enrolled.\n* Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.\n* Written assent obtained from the subject if/as required by local regulations.\n* Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.\n* Access to a consistent means of telephone contact\n\nExclusion Criteria:\n\n* Child in care.\n* Use of an investigational or non-registered product other than the study vaccines within 30 days before study vaccination or planned use during study period. Routine registered childhood vaccinations are permitted.\n* Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period. Prior receipt of more than one dose of a licensed hepatitis A vaccine, with the first dose administered at \\>=12 months of age.\n* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.\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* History of Guillain-Barre syndrome within 6 weeks of receipt of prior influenza virus vaccine.\n* Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to constituent of vaccine; or a history of severe adverse reaction to a previous influenza vaccine.\n* Fever at the time of enrolment.\n* Acute disease at the time of enrolment.\n* Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n* Ongoing aspirin therapy.\n* Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study."}, 'identificationModule': {'nctId': 'NCT01218308', 'briefTitle': "A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Efficacy Study of GSK Biologicals' Quadrivalent Influenza Vaccine, GSK2282512A, (FLU Q-QIV) When Administered in Children", 'orgStudyIdInfo': {'id': '114541'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FluLaval® Quadrivalent Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.', 'interventionNames': ['Biological: FluLaval® Quadrivalent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Havrix Group', 'description': 'Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.', 'interventionNames': ['Biological: Havrix™']}], 'interventions': [{'name': 'FluLaval® Quadrivalent', 'type': 'BIOLOGICAL', 'otherNames': ['Quadrivalent seasonal influenza vaccine GSK2282512A'], 'description': 'One intramuscular dose for primed subjects. Two intramuscular doses for unprimed subjects.', 'armGroupLabels': ['FluLaval® Quadrivalent Group']}, {'name': 'Havrix™', 'type': 'BIOLOGICAL', 'description': 'Two intramuscular doses for primed subjects. Three intramuscular doses for unprimed subjects.', 'armGroupLabels': ['Havrix Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}, {'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'city': 'Tegucigalpa', 'country': 'Honduras', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.0818, 'lon': -87.20681}}, {'zip': '1107-2020', 'city': 'Beirut', 'country': 'Lebanon', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'city': 'Panama City', 'country': 'Panama', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'zip': '1781', 'city': 'City of Muntinlupa', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.39028, 'lon': 121.0475}}, {'zip': '4114', 'city': 'Dasmariñas, Cavite', 'country': 'Philippines', 'facility': 'GSK Investigational Site'}, {'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '1330', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'zip': '6100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Eskişehir', 'country': 'Turkey (Türkiye)', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.77667, 'lon': 30.52056}}, {'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}