Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-26 @ 5:35 PM
Study NCT ID:
NCT00778895
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2008-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study in Children, 6 Months to 3 Years of Age, to Assess Two Dose Levels of an Experimental Flu Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}, {'id': 'C478242', 'term': 'vaxigrip'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events were assessed during the 28 day post vaccination period and the 6-month safety follow-up period. Systematically and non-systematically assessed frequent adverse events were assessed during 4 day and 28 day post vaccination periods.', 'description': 'For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Fluviral F1 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.', 'otherNumAtRisk': 164, 'otherNumAffected': 129, 'seriousNumAtRisk': 164, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Fluviral F2 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.', 'otherNumAtRisk': 167, 'otherNumAffected': 138, 'seriousNumAtRisk': 167, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Vaxigrip Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.', 'otherNumAtRisk': 43, 'otherNumAffected': 34, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 83}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pneumonia', 'notes': 'SAE was assessed within the 28-day post vaccination period.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchial hyperreactivity', 'notes': 'SAE was assessed within the 28-day post vaccination period.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lobar pneumonia', 'notes': 'SAE was assessed through the 6-month safety follow-up period.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral pharyngitis', 'notes': 'SAE was assessed through the 6-month safety follow-up period.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluviral F1 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'Fluviral F2 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'title': 'Any pain', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any redness', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 redness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any swelling', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day follow-up period (Days 0-3) after any vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluviral F1 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'Fluviral F2 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'title': 'Any drowsiness', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 drowsiness', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Related drowsiness', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Any irritability', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 irritability', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Related irritability', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Any loss of appetite', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 loss of appetite', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Related loss of appetite', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Any fever', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 fever', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related fever', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day follow-up period (Days 0-3) after any vaccination', 'description': 'Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluviral F1 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'Fluviral F2 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'title': 'Any unsolicited AE(s)', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 unsolicited AE(s)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Related unsolicited AE(s)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 28-day follow-up period (Days 0-27) after vaccination', 'description': 'Unsolicited AEs 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 = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluviral F1 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'Fluviral F2 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 28-day post-vaccination period', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.\n\nAnalysis of intensity and relationship to vaccination of MAEs was not performed.\n\nThis primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluviral F1 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'Fluviral F2 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 6-month safety follow up after vaccination', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.\n\nAnalysis of intensity and relationship to vaccination of MAEs was not performed.\n\nThis primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluviral F1 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'Fluviral F2 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'title': 'Any SAE(s)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related SAE(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 28-day post-vaccination period', 'description': 'SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.\n\nThis primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluviral F1 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'Fluviral F2 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'title': 'Any SAE(s)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related SAE(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 6-month safety follow up after vaccination', 'description': 'SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.\n\nThis primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.', 'unitOfMeasure': 'Participants', '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': 'Titers for Serum Hemagglutination Inhibition (HI) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluviral F1 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'Fluviral F2 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'Vaxigrip Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'title': 'A/Brisbane (H1N1) strain [PRE]', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '10.1'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '10.3'}, {'value': '8.1', 'groupId': 'OG002', 'lowerLimit': '5.9', 'upperLimit': '11.0'}]}]}, {'title': 'A/Brisbane (H1N1) strain [POST]', 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000', 'lowerLimit': '39.5', 'upperLimit': '80.2'}, {'value': '70.7', 'groupId': 'OG001', 'lowerLimit': '50.7', 'upperLimit': '98.6'}, {'value': '120.9', 'groupId': 'OG002', 'lowerLimit': '73.4', 'upperLimit': '199.0'}]}]}, {'title': 'A/Uruguay (H3N2) strain [PRE]', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '8.3'}, {'value': '9.2', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '11.4'}, {'value': '7.3', 'groupId': 'OG002', 'lowerLimit': '4.9', 'upperLimit': '11.1'}]}]}, {'title': 'A/Uruguay (H3N2) strain [POST]', 'categories': [{'measurements': [{'value': '64.5', 'groupId': 'OG000', 'lowerLimit': '48.2', 'upperLimit': '86.4'}, {'value': '89.5', 'groupId': 'OG001', 'lowerLimit': '67.4', 'upperLimit': '119.0'}, {'value': '97.8', 'groupId': 'OG002', 'lowerLimit': '59.0', 'upperLimit': '162.4'}]}]}, {'title': 'B/Florida strain [PRE]', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '9.4'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '9.4'}, {'value': '10.8', 'groupId': 'OG002', 'lowerLimit': '6.9', 'upperLimit': '16.9'}]}]}, {'title': 'B/Florida strain [POST]', 'categories': [{'measurements': [{'value': '128.7', 'groupId': 'OG000', 'lowerLimit': '100.3', 'upperLimit': '165.1'}, {'value': '163.7', 'groupId': 'OG001', 'lowerLimit': '130.1', 'upperLimit': '206.0'}, {'value': '190.3', 'groupId': 'OG002', 'lowerLimit': '119.0', 'upperLimit': '304.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 0 [PRE] and at 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. Antibodies assessed were antibodies against the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida flu strains.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures 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 Seroconverted to HI Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluviral F1 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'Fluviral F2 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'Vaxigrip Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'title': 'A/Brisbane (H1N1) [POST]', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'A/Uruguay (H3N2) [POST]', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'B/Florida [POST]', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 28 (for primed subjects) and at 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 flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures 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 Seroprotected Against HI Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluviral F1 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'Fluviral F2 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'Vaxigrip Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'title': 'A/Brisbane (H1N1) [PRE]', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'A/Brisbane (H1N1) [POST]', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'A/Uruguay (H3N2) [PRE]', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'A/Uruguay (H3N2) [POST]', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'B/Florida [PRE]', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'B/Florida [POST]', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]', 'description': 'A seroprotected subject was defined as a vaccinated subject with serum HI titer ≥ 1:40.\n\nThe flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures 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 Factor for HI Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluviral F1 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'Fluviral F2 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'Vaxigrip Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'title': 'A/Brisbane (H1N1) [POST]', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '8.9'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '10.6'}, {'value': '14.9', 'groupId': 'OG002', 'lowerLimit': '9.6', 'upperLimit': '23.3'}]}]}, {'title': 'A/Uruguay (H3N2) [POST]', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '11.7'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '11.9'}, {'value': '13.3', 'groupId': 'OG002', 'lowerLimit': '8.9', 'upperLimit': '19.9'}]}]}, {'title': 'B/Florida [POST]', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '20.5'}, {'value': '20.7', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '26.2'}, {'value': '17.6', 'groupId': 'OG002', 'lowerLimit': '10.4', 'upperLimit': '29.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]', 'description': 'The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination (at Day 28 for primed subjects and at Day 56 for unprimed subjects) compared to pre-vaccination (Day 0).\n\nThe flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.', 'unitOfMeasure': 'fold increase', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures 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 and Grade 3 Solicited Local Symptoms After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaxigrip Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'title': 'Any pain', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Any redness', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 redness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Any swelling', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day follow-up period (Days 0-3) after any vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).\n\nThis secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaxigrip Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'title': 'Any drowsiness', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 drowsiness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related drowsiness', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Any irritability', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 irritability', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Related irritability', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Any loss of appetite', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 loss of appetite', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related loss of appetite', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Any fever', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 fever', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related fever', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day follow-up period (Days 0-3) after any vaccination', 'description': 'Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination.\n\nThis secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaxigrip Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'title': 'Any unsolicited AE(s)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 unsolicited AE(s)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Related unsolicited AE(s)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 28-day follow-up period (Days 0-27) after vaccination', 'description': 'Unsolicited AEs 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 = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination.\n\nThis secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.', 'unitOfMeasure': 'Participants', '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, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaxigrip Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 28-day post-vaccination period after vaccination', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.\n\nAnalysis of intensity and relationship to vaccination of MAEs was not performed.\n\nThis secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.', 'unitOfMeasure': 'Participants', '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, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaxigrip Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 6-month safety follow up after vaccination', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.\n\nAnalysis of intensity and relationship to vaccination of MAEs was not performed.\n\nThis secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.', 'unitOfMeasure': 'Participants', '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) After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaxigrip Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'title': 'Any SAE(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related SAE(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 28-day post-vaccination period', 'description': 'SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.\n\nThis secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.', 'unitOfMeasure': 'Participants', '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) After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaxigrip Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'classes': [{'title': 'Any SAE(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related SAE(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 6-month safety follow up after vaccination', 'description': 'SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.\n\nThis secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.', 'unitOfMeasure': 'Participants', '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': 'Fluviral F1 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'FG001', 'title': 'Fluviral F2 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'FG002', 'title': 'Vaxigrip Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}], 'periods': [{'title': 'Active Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}, {'groupId': 'FG001', 'numSubjects': '167'}, {'groupId': 'FG002', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '161'}, {'groupId': 'FG002', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'ESFU Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}, {'groupId': 'FG001', 'numSubjects': '167'}, {'groupId': 'FG002', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '155'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were differentiated according to priming status. Primed Subjects - subjects who had a prior 2-dose priming influenza immunization received a 1-dose vaccination course in the study. Unprimed Subjects - subjects who had not previously received a complete 2-dose priming influenza immunization received a 2-dose vaccination course in the study.', 'preAssignmentDetails': 'Study comprised an Active phase of approximately 2 months and a post-vaccination 180 day extended safety follow-up period (ESFU phase).\n\n374 subjects out of the 390 who were enrolled in the study were vaccinated. Remaining subjects were not included in the participant flow as started as they failed to meet protocol criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '374', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluviral F1 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'BG001', 'title': 'Fluviral F2 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'BG002', 'title': 'Vaxigrip Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '18.2', 'spread': '9.06', 'groupId': 'BG000'}, {'value': '17.5', 'spread': '8.27', 'groupId': 'BG001'}, {'value': '17.0', 'spread': '8.33', 'groupId': 'BG002'}, {'value': '17.7', 'spread': '8.62', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '195', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'dispFirstSubmitDate': '2011-11-16', 'completionDateStruct': {'date': '2009-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-02', 'studyFirstSubmitDate': '2008-10-23', 'dispFirstSubmitQcDate': '2011-11-16', 'resultsFirstSubmitDate': '2012-12-19', 'studyFirstSubmitQcDate': '2008-10-23', 'dispFirstPostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-07-03', 'studyFirstPostDateStruct': {'date': '2008-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination', 'timeFrame': 'During the 4-day follow-up period (Days 0-3) after any vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination', 'timeFrame': 'During the 4-day follow-up period (Days 0-3) after any vaccination', 'description': 'Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination', 'timeFrame': 'During the 28-day follow-up period (Days 0-27) after vaccination', 'description': 'Unsolicited AEs 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 = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination', 'timeFrame': 'During the 28-day post-vaccination period', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.\n\nAnalysis of intensity and relationship to vaccination of MAEs was not performed.\n\nThis primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination', 'timeFrame': 'During the 6-month safety follow up after vaccination', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.\n\nAnalysis of intensity and relationship to vaccination of MAEs was not performed.\n\nThis primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.'}, {'measure': 'Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination', 'timeFrame': 'During the 28-day post-vaccination period', 'description': 'SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.\n\nThis primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.'}, {'measure': 'Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination', 'timeFrame': 'During the 6-month safety follow up after vaccination', 'description': 'SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.\n\nThis primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.'}], 'secondaryOutcomes': [{'measure': 'Titers for Serum Hemagglutination Inhibition (HI) Antibodies', 'timeFrame': 'At Day 0 [PRE] and at 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. Antibodies assessed were antibodies against the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida flu strains.'}, {'measure': 'Number of Subjects Seroconverted to HI Antibodies', 'timeFrame': 'At Day 28 (for primed subjects) and at 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 flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.'}, {'measure': 'Number of Subjects Seroprotected Against HI Antibodies', 'timeFrame': 'At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]', 'description': 'A seroprotected subject was defined as a vaccinated subject with serum HI titer ≥ 1:40.\n\nThe flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.'}, {'measure': 'Seroconversion Factor for HI Antibodies', 'timeFrame': 'At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]', 'description': 'The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination (at Day 28 for primed subjects and at Day 56 for unprimed subjects) compared to pre-vaccination (Day 0).\n\nThe flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination', 'timeFrame': 'During the 4-day follow-up period (Days 0-3) after any vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).\n\nThis secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination', 'timeFrame': 'During the 4-day follow-up period (Days 0-3) after any vaccination', 'description': 'Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination.\n\nThis secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination', 'timeFrame': 'During the 28-day follow-up period (Days 0-27) after vaccination', 'description': 'Unsolicited AEs 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 = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination.\n\nThis secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination', 'timeFrame': 'During the 28-day post-vaccination period after vaccination', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.\n\nAnalysis of intensity and relationship to vaccination of MAEs was not performed.\n\nThis secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination', 'timeFrame': 'During the 6-month safety follow up after vaccination', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.\n\nAnalysis of intensity and relationship to vaccination of MAEs was not performed.\n\nThis secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.'}, {'measure': 'Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination', 'timeFrame': 'During the 28-day post-vaccination period', 'description': 'SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.\n\nThis secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.'}, {'measure': 'Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination', 'timeFrame': 'During the 6-month safety follow up after vaccination', 'description': 'SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.\n\nThis secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.'}]}, 'conditionsModule': {'keywords': ['Flu', 'Safety', 'Immunogenicity', 'Flu vaccine', 'Influenza', 'Virus'], 'conditions': ['Influenza']}, 'referencesModule': {'availIpds': [{'id': '111635', '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': '111635', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111635', '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': '111635', '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': '111635', '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': '111635', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '23687572', 'type': 'DERIVED', 'citation': 'Langley JM, Vanderkooi OG, Garfield HA, Hebert J, Chandrasekaran V, Jain VK, Fries L. Immunogenicity and Safety of 2 Dose Levels of a Thimerosal-Free Trivalent Seasonal Influenza Vaccine in Children Aged 6-35 Months: A Randomized, Controlled Trial. J Pediatric Infect Dis Soc. 2012 Mar;1(1):55-63. doi: 10.1093/jpids/pis012. Epub 2012 Mar 1.'}], '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': 'Children younger than 5 years of age are at high risk for severe influenza disease (flu) and hospitalization due to flu. Scientists are in the process of re-evaluating the dosing initially based on whole virus vaccines to improve their efficacy in infants. In this study, we will compare two different dose levels of GSK1557482A flu vaccine. Another already approved flu vaccine made by a different company will be used as a control.', 'detailedDescription': 'This is a study of two different dose levels of a new formulation of flu vaccine for the 2008/2009 flu season using the World Health Organization recommended virus strains. Subjects will be randomly put into one of three different groups to receive either one or two doses of:\n\n0.25 mL dose of the new flu vaccine, or 0.5 mL dose of the new flu vaccine or the licensed Vaxigrip flu vaccine (control) The parents of the subjects and the study doctor and nurses will not know the group of their child until the study is completed.\n\nThe children will be vaccinated with either one dose or two doses depending on whether or not they have received a flu vaccine before. The doctor will decide on the schedule for each child based on the information provided by the parents. The active phase of the study will last approximately two months for children receiving two doses and one month for those receiving a single dose. An extended safety follow-up will continue until Study Month 6.\n\nTwo blood samples will be taken from each subject. These will be used to evaluate how well the vaccine works in the children and which dose level works best compared to the control.\n\nThe parents will fill in a diary card for four days to record any reactions or symptoms which may occur after vaccination. Parents will also keep a record of other symptoms that may occur between vaccinations and up to six months after the first vaccination and will keep a record of any medication their child takes in this time period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A male or female child 6 months to \\< 3 years of age at the time of the vaccination, regardless of previous administration of influenza vaccine in a previous season;\n* Subjects must be in good health established by medical history and physical examination before entering into the study;\n* Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study;\n* Written informed consent obtained from the subject's parent/guardian.\n* Parents/guardian access to a consistent means of telephone contact, land line or mobile\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion;\n* History of hypersensitivity to any vaccine;\n* History of allergy to or reactions likely to be exacerbated by, any component of the vaccine including egg, chicken protein, formaldehyde, or sodium deoxycholate;\n* History of any congenital, acquired, or iatrogenic immunodeficiency state (current or potential) including HIV infection, disorders of the lymphoid system or bone marrow, or chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune-modifying drugs within 3 months prior to the administration of the study vaccine.\n* Acute disease at the time of enrolment.\n* History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine;\n* Any significant disorder of blood coagulation or treatment with vitamin K antagonists; or any known disorder of hemostasis;\n* Receipt of any immunoglobulins and/or any blood products within three months of study enrollment or planned administration of any of these products during the study period.\n* Receipt of a non-study related influenza vaccine outside of this study and during the current (2008-09) influenza immunization campaign.\n* Any use of analgesics/antipyretics 12 hours before receipt of vaccine."}, 'identificationModule': {'nctId': 'NCT00778895', 'briefTitle': 'Clinical Study in Children, 6 Months to 3 Years of Age, to Assess Two Dose Levels of an Experimental Flu Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Clinical Study in Children, 6 Months to 3 Years of Age, to Assess the Immunogenicity and Safety of Two Dose Levels of Thimerosal-free Fluviral® Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control', 'orgStudyIdInfo': {'id': '111635'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluviral F1 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.', 'interventionNames': ["Biological: GSK Biologicals' influenza vaccine GSK1557482A"]}, {'type': 'EXPERIMENTAL', 'label': 'Fluviral F2 Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.', 'interventionNames': ["Biological: GSK Biologicals' influenza vaccine GSK1557482A"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vaxigrip Group', 'description': 'Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.', 'interventionNames': ['Biological: Vaxigrip']}], 'interventions': [{'name': "GSK Biologicals' influenza vaccine GSK1557482A", 'type': 'BIOLOGICAL', 'otherNames': ['Fluviral'], 'description': 'one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).', 'armGroupLabels': ['Fluviral F1 Group', 'Fluviral F2 Group']}, {'name': 'Vaxigrip', 'type': 'BIOLOGICAL', 'description': 'one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).', 'armGroupLabels': ['Vaxigrip Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3B 6A8', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V3A 4H9', 'city': 'Langley', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.10107, 'lon': -122.65883}}, {'zip': 'R3E 3P4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'A1N 5B6', 'city': 'Mount Pearl', 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.51659, 'lon': -52.78135}}, {'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'P3E 1H5', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'L8L 5G8', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 5R9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'N6H 4P2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L5A 3V4', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L3Y 5G8', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'N7T 4X3', 'city': 'Sarnia', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'zip': 'M5G 1N8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'C1A 5N4', 'city': 'Charlottetown', 'state': 'Prince Edward Island', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.23459, 'lon': -63.1256}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4M6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G1X 3V7', 'city': 'Ste-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site'}, {'zip': 'G8T 7A1', 'city': 'Trois-Rivières', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}], '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'}}}}