Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT00964158
Status:
COMPLETED
Last Update Posted:
2018-02-19
First Post:
2009-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 21-day (Days 0-20) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).', 'eventGroups': [{'id': 'EG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 52, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 57, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 95, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 60, 'numAffected': 44}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 47, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 35, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 33, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 33, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 47, 'numAffected': 33}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 50, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 95, 'numAffected': 63}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 23, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 51, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 105, 'numAffected': 71}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 29, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 31, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 82, 'numAffected': 56}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 85, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 109, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 181, 'numAffected': 95}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 44, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 34, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 41, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 28, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 34, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 42, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 91, 'numAffected': 60}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A Group', 'description': 'Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0', 'description': 'The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With HI Antibody Concentrations Above the Cut-off Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A Group', 'description': 'Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 42', 'description': 'The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.'}, {'type': 'PRIMARY', 'title': 'Titers for Serum HI Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A Group', 'description': 'Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '8.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 0', 'description': 'Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.'}, {'type': 'PRIMARY', 'title': 'Titers for Serum HI Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A Group', 'description': 'Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1538.5', 'groupId': 'OG000', 'lowerLimit': '1419.0', 'upperLimit': '1668.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 42', 'description': 'Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.'}, {'type': 'PRIMARY', 'title': 'Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A Group', 'description': 'Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 42', 'description': 'A seroconverted subject was defined as: For initially seronegative subjects \\[antibody titer below (\\<) 1:10 prior to vaccination\\], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A Group', 'description': 'Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 42', 'description': 'Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.'}, {'type': 'PRIMARY', 'title': 'Seroconversion Factor (SCF) for HI Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A Group', 'description': 'Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '208.5', 'groupId': 'OG000', 'lowerLimit': '179.0', 'upperLimit': '242.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 42', 'description': 'Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.', 'unitOfMeasure': 'Fold increase', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With HI Antibody Concentrations Above the Cut-off Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'title': 'Flu A/CAL/7/09, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Flu A/CAL/7/09, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}]}, {'title': 'Flu A/CAL/7/09, Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}, {'title': 'Flu A/CAL/7/09, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 0, 21, 42 and at Month 12', 'description': 'The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.'}, {'type': 'SECONDARY', 'title': 'Titers for Serum HI Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'title': 'Flu A/CAL/7/09, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '5.0'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '7.7'}, {'value': '8.9', 'groupId': 'OG002', 'lowerLimit': '6.9', 'upperLimit': '11.3'}]}]}, {'title': 'Flu A/CAL/7/09, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '168.3', 'groupId': 'OG000', 'lowerLimit': '140.5', 'upperLimit': '201.6'}, {'value': '284.4', 'groupId': 'OG001', 'lowerLimit': '218.3', 'upperLimit': '370.5'}, {'value': '547.9', 'groupId': 'OG002', 'lowerLimit': '457.1', 'upperLimit': '656.8'}]}]}, {'title': 'Flu A/CAL/7/09, Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1581.1', 'groupId': 'OG000', 'lowerLimit': '1365.7', 'upperLimit': '1830.6'}, {'value': '964.6', 'groupId': 'OG001', 'lowerLimit': '847.4', 'upperLimit': '1098.0'}, {'value': '1008.9', 'groupId': 'OG002', 'lowerLimit': '881.3', 'upperLimit': '1155.0'}]}]}, {'title': 'Flu A/CAL/7/09, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '123.9', 'groupId': 'OG000', 'lowerLimit': '102.8', 'upperLimit': '149.3'}, {'value': '106.3', 'groupId': 'OG001', 'lowerLimit': '88.6', 'upperLimit': '127.5'}, {'value': '251.0', 'groupId': 'OG002', 'lowerLimit': '206.6', 'upperLimit': '304.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 0, 21, 42 and at Month 12', 'description': 'Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.'}, {'type': 'SECONDARY', 'title': 'Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'title': 'Flu A/CAL/7/09, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}]}, {'title': 'Flu A/CAL/7/09, Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}]}, {'title': 'Flu A/CAL/7/09, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 21, 42 and at Month 12', 'description': 'A seroconverted subject was defined as: For initially seronegative subjects \\[antibody titer below (\\<) 1:10 prior to vaccination\\], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination antibody titer. The flu strain assessed was Flu A/CAL/7/09.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects in Terms of HI Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'title': 'Flu A/CAL/7/09, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Flu A/CAL/7/09, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}]}, {'title': 'Flu A/CAL/7/09, Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}, {'title': 'Flu A/CAL/7/09, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 0, 21, 42 and at Month 12', 'description': 'Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.'}, {'type': 'SECONDARY', 'title': 'Seroconversion Factor (SCF) for HI Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'title': 'Flu A/CAL/7/09, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.7', 'groupId': 'OG000', 'lowerLimit': '28.1', 'upperLimit': '40.3'}, {'value': '44.9', 'groupId': 'OG001', 'lowerLimit': '36.0', 'upperLimit': '56.1'}, {'value': '61.8', 'groupId': 'OG002', 'lowerLimit': '48.4', 'upperLimit': '78.8'}]}]}, {'title': 'Flu A/CAL/7/09, Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '316.2', 'groupId': 'OG000', 'lowerLimit': '273.1', 'upperLimit': '366.1'}, {'value': '151.7', 'groupId': 'OG001', 'lowerLimit': '123.4', 'upperLimit': '186.5'}, {'value': '119.8', 'groupId': 'OG002', 'lowerLimit': '92.3', 'upperLimit': '155.4'}]}]}, {'title': 'Flu A/CAL/7/09, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '29.9'}, {'value': '16.8', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': '20.5'}, {'value': '28.3', 'groupId': 'OG002', 'lowerLimit': '22.2', 'upperLimit': '36.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 21, 42 and at Month 12', 'description': 'Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.', 'unitOfMeasure': 'Fold increase', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'title': 'Flu A/Neth/602/09, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Flu A/Neth/602/09, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Flu A/Neth/602/09, Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 0, 21 and 42', 'description': 'The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.'}, {'type': 'SECONDARY', 'title': 'Titers for Serum Neutralizing Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'title': 'Flu A/Neth/602/09, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '4.4'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '8.8'}, {'value': '5.3', 'groupId': 'OG002', 'lowerLimit': '3.6', 'upperLimit': '7.9'}]}]}, {'title': 'Flu A/Neth/602/09, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '60.2', 'groupId': 'OG000', 'lowerLimit': '42.4', 'upperLimit': '85.5'}, {'value': '149.0', 'groupId': 'OG001', 'lowerLimit': '80.7', 'upperLimit': '275.0'}, {'value': '113.0', 'groupId': 'OG002', 'lowerLimit': '71.5', 'upperLimit': '178.8'}]}]}, {'title': 'Flu A/Neth/602/09, Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1277.4', 'groupId': 'OG000', 'lowerLimit': '895.1', 'upperLimit': '1822.9'}, {'value': '751.0', 'groupId': 'OG001', 'lowerLimit': '491.0', 'upperLimit': '1148.6'}, {'value': '553.4', 'groupId': 'OG002', 'lowerLimit': '388.4', 'upperLimit': '788.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 0, 21 and 42', 'description': 'Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was A/Netherlands/602/2009 (H1N1)v-like (Flu A/Neth/602/09).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 12', 'description': 'The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.'}, {'type': 'SECONDARY', 'title': 'Titers for Serum Neutralizing Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '269.1', 'groupId': 'OG000', 'lowerLimit': '198.9', 'upperLimit': '363.9'}, {'value': '168.4', 'groupId': 'OG001', 'lowerLimit': '121.0', 'upperLimit': '234.4'}, {'value': '118.1', 'groupId': 'OG002', 'lowerLimit': '85.6', 'upperLimit': '163.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 12', 'description': 'Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was Flu A/Neth/602/09.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.'}, {'type': 'SECONDARY', 'title': 'Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'title': 'Flu A/Neth/602/09, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Flu A/Neth/602/09, Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 21 and 42', 'description': 'A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.'}, {'type': 'SECONDARY', 'title': 'Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 12', 'description': 'A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'title': 'Any Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Redness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Any Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Any Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Redness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'title': 'Any Diarrhea, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Diarrhea, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related Diarrhea, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Any Drowsiness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Drowsiness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related Drowsiness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Any Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related Irritability, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Any Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related Loss of appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Any Shivering, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Shivering, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related Shivering, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Any Sweating, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Sweating, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related Sweating, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Any Temperature, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Temperature, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Related Temperature, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Any Diarrhea, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Diarrhea, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related Diarrhea, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Any Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Related Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Any Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Related Irritability, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Any Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Related Loss of appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Any Shivering, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Shivering, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Related Shivering, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Any Sweating, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Sweating, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related Sweating, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Any Temperature, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Temperature, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Related Temperature, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Any Diarrhea, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Diarrhea, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related Diarrhea, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Any Drowsiness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Drowsiness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Related Drowsiness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Any Irritability, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Irritability, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Related Irritability, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Any Loss of appetite, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Loss of appetite, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Related Loss of appetite, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Any Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Related Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Any Sweating, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Sweating, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related Sweating, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Any Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Related Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited general symptoms were diarrhea, drowsiness, irritability, loss of appetite, shivering, sweating and fever \\[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'title': 'Any Arthralgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Arthralgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Any Shivering, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Shivering, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Shivering, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Any Sweating, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Sweating, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Sweating, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any Temperature, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Temperature, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Temperature, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Any Arthralgia, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Arthralgia, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Any Shivering, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Shivering, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Shivering, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Any Sweating, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Sweating, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Sweating, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any Temperature, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Temperature, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Temperature, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Any Arthralgia, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Arthralgia, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Any Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Any Sweating, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Sweating, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Sweating, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Any Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and fever \\[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Medically-attended Events (MAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (from Day 0 up to Month 12)', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (from Day 0 up to Month 12)', 'description': 'An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Normal or Abnormal Biochemical Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'title': 'ALAT, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Within', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALAT, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Within', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'ALAT, Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Within', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'ASAT, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Within', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'ASAT, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Within', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'ASAT, Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Within', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'BILI, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Within', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'BILI, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Within', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'BILI, Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Within', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Below', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Within', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Below', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Within', 'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Below', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Within', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'BUN, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Within', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'BUN, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Below', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Within', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'BUN, Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Within', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}, {'title': 'Above', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 0, 21 and 42', 'description': 'Among biochemical parameters assessed were alanine aminotransferase \\[ALAT\\], aspartate aminotransferase \\[ASAT\\], bilirubin \\[BILI\\], creatinine \\[CREA\\] and blood urea nitrogen \\[BUN\\]. Levels of biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'title': 'Any AE(s)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 AE(s)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Related AE(s)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 21-day (Days 0-20) follow-up period after the first vaccination', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'title': 'Any AE(s)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 AE(s)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Related AE(s)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'OG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (from Day 0 up to Month 12)', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'FG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'FG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '92'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '210', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'GSK2340272A (3-5Y) Group', 'description': 'Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'BG001', 'title': 'GSK2340272A (6-9Y) Group', 'description': 'Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.'}, {'id': 'BG002', 'title': 'GSK2340272A (10-17Y) Group', 'description': 'Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly 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': '3.5', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '7.5', 'spread': '1.18', 'groupId': 'BG001'}, {'value': '13.3', 'spread': '2.23', 'groupId': 'BG002'}, {'value': '9.25', 'spread': '4.46', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Geographic ancestry', 'categories': [{'title': 'Asian - East Asian heritage', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White - Caucasian/European heritage', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '208', 'groupId': 'BG003'}]}, {'title': 'Unspecified', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'dispFirstSubmitDate': '2010-12-10', 'completionDateStruct': {'date': '2010-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-31', 'studyFirstSubmitDate': '2009-08-20', 'dispFirstSubmitQcDate': '2010-12-10', 'resultsFirstSubmitDate': '2017-07-31', 'studyFirstSubmitQcDate': '2009-08-20', 'dispFirstPostDateStruct': {'date': '2010-12-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-31', 'studyFirstPostDateStruct': {'date': '2009-08-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value', 'timeFrame': 'At Day 0', 'description': 'The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).'}, {'measure': 'Number of Subjects With HI Antibody Concentrations Above the Cut-off Value', 'timeFrame': 'At Day 42', 'description': 'The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.'}, {'measure': 'Titers for Serum HI Antibodies', 'timeFrame': 'At Day 0', 'description': 'Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.'}, {'measure': 'Titers for Serum HI Antibodies', 'timeFrame': 'At Day 42', 'description': 'Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.'}, {'measure': 'Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies', 'timeFrame': 'At Day 42', 'description': 'A seroconverted subject was defined as: For initially seronegative subjects \\[antibody titer below (\\<) 1:10 prior to vaccination\\], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.'}, {'measure': 'Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies', 'timeFrame': 'At Day 42', 'description': 'Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.'}, {'measure': 'Seroconversion Factor (SCF) for HI Antibody Titers', 'timeFrame': 'At Day 42', 'description': 'Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With HI Antibody Concentrations Above the Cut-off Value', 'timeFrame': 'At Days 0, 21, 42 and at Month 12', 'description': 'The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.'}, {'measure': 'Titers for Serum HI Antibodies', 'timeFrame': 'At Days 0, 21, 42 and at Month 12', 'description': 'Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.'}, {'measure': 'Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies', 'timeFrame': 'At Days 21, 42 and at Month 12', 'description': 'A seroconverted subject was defined as: For initially seronegative subjects \\[antibody titer below (\\<) 1:10 prior to vaccination\\], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination antibody titer. The flu strain assessed was Flu A/CAL/7/09.'}, {'measure': 'Number of Seroprotected Subjects in Terms of HI Antibodies', 'timeFrame': 'At Days 0, 21, 42 and at Month 12', 'description': 'Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.'}, {'measure': 'Seroconversion Factor (SCF) for HI Antibody Titers', 'timeFrame': 'At Days 21, 42 and at Month 12', 'description': 'Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.'}, {'measure': 'Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value', 'timeFrame': 'At Days 0, 21 and 42', 'description': 'The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.'}, {'measure': 'Titers for Serum Neutralizing Antibodies', 'timeFrame': 'At Days 0, 21 and 42', 'description': 'Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was A/Netherlands/602/2009 (H1N1)v-like (Flu A/Neth/602/09).'}, {'measure': 'Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value', 'timeFrame': 'At Month 12', 'description': 'The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.'}, {'measure': 'Titers for Serum Neutralizing Antibodies', 'timeFrame': 'At Month 12', 'description': 'Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was Flu A/Neth/602/09.'}, {'measure': 'Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies', 'timeFrame': 'At Days 21 and 42', 'description': 'A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.'}, {'measure': 'Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies', 'timeFrame': 'At Month 12', 'description': 'A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited general symptoms were diarrhea, drowsiness, irritability, loss of appetite, shivering, sweating and fever \\[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and fever \\[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Any Medically-attended Events (MAEs)', 'timeFrame': 'During the entire study period (from Day 0 up to Month 12)', '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.'}, {'measure': 'Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs)', 'timeFrame': 'During the entire study period (from Day 0 up to Month 12)', 'description': 'An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.'}, {'measure': 'Number of Subjects With Normal or Abnormal Biochemical Levels', 'timeFrame': 'At Days 0, 21 and 42', 'description': 'Among biochemical parameters assessed were alanine aminotransferase \\[ALAT\\], aspartate aminotransferase \\[ASAT\\], bilirubin \\[BILI\\], creatinine \\[CREA\\] and blood urea nitrogen \\[BUN\\]. Levels of biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 21-day (Days 0-20) follow-up period after the first vaccination', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'During the entire study period (from Day 0 up to Month 12)', '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.'}]}, 'conditionsModule': {'keywords': ['influenza infection', "GSK Bio's influenza vaccine GSK2340272A"], 'conditions': ['Influenza']}, 'referencesModule': {'availIpds': [{'id': '113528', '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': '113528', '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': '113528', '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': '113528', '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': '113528', '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': '113528', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113528', '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': '26176592', 'type': 'DERIVED', 'citation': 'Garcia-Sicilia J, Aristegui J, Omenaca F, Carmona A, Tejedor JC, Merino JM, Garcia-Corbeira P, Walravens K, Bambure V, Moris P, Caplanusi A, Gillard P, Dieussaert I. Safety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies. Hum Vaccin Immunother. 2015;11(10):2359-69. doi: 10.1080/21645515.2015.1063754.'}, {'pmid': '21504774', 'type': 'DERIVED', 'citation': 'Garcia-Sicilia J, Gillard P, Carmona A, Tejedor JC, Aristegui J, Merino JM, Behre U, Caplanusi A, Vaman T, Dieussaert I. Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents. Vaccine. 2011 Jun 10;29(26):4353-61. doi: 10.1016/j.vaccine.2011.04.011. Epub 2011 Apr 17.'}], '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 trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.\n* Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.\n* Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.\n* Healthy children as established by medical history and clinical examination when entering into the study.\n* Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.\n* Clinically or virologically confirmed influenza infection within six months preceding the study start.\n* Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.\n* Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.\n* Acute disease and/or fever at the time of enrolment\n* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.\n* Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.\n* Previous administration of any H1N1 A/California-like vaccine.\n* Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.\n* If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.\n* Any known or suspected allergy to any constituent of influenza vaccines;a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.\n* Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.\n* Child in Care.'}, 'identificationModule': {'nctId': 'NCT00964158', 'briefTitle': "Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years", 'orgStudyIdInfo': {'id': '113528'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'interventionNames': ['Biological: Pandemic influenza vaccine GSK2340272A']}], 'interventions': [{'name': 'Pandemic influenza vaccine GSK2340272A', 'type': 'BIOLOGICAL', 'description': 'Two primary intramuscular (IM) injections and a booster IM injection', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48013', 'city': 'Bilbao', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '09005', 'city': 'Burgos', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28935', 'city': 'Móstoles/Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site'}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], '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'}}}}