Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT00885105
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2009-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactUs@sanofipasteur.com', 'title': 'Medical Director', 'organization': 'Sanofi Pasteur Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected over a period of 8 months. Six months post-vaccination 2', 'eventGroups': [{'id': 'EG000', 'title': 'Fluzone® Vaccine-Primed Group', 'description': 'Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.', 'otherNumAtRisk': 112, 'otherNumAffected': 57, 'seriousNumAtRisk': 112, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Influenza Vaccine-Naive Group', 'description': 'Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.', 'otherNumAtRisk': 130, 'otherNumAffected': 56, 'seriousNumAtRisk': 130, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 34, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 31, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}], 'seriousEvents': [{'term': 'Sickle cell anaemia with crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Deafness bilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone® Vaccine-Primed Group', 'description': 'Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.'}, {'id': 'OG001', 'title': 'Influenza Vaccine-Naive Group', 'description': 'Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.'}], 'classes': [{'title': 'A/New Caledonia/20/99 Post-Dose 1', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'A/New York/55/2004 Post-Dose 1', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'B/Jiangsu/310/2003 Post-Dose 1', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'A/New Caledonia/20/99 Post-Dose 2', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'A/New York/55/2004 Post-Dose 2', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'B/Jiangsu/310/2003 Post-Dose 2', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 Post-vaccination', 'description': 'Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Hemagglutination inhibition titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone® Vaccine-Primed Group', 'description': 'Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.'}, {'id': 'OG001', 'title': 'Influenza Vaccine-Naive Group', 'description': 'Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.'}], 'classes': [{'title': 'A/New Caledonia/20/99 Post-Dose 1', 'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000', 'lowerLimit': '22.3', 'upperLimit': '41.8'}, {'value': '18.9', 'groupId': 'OG001', 'lowerLimit': '14.1', 'upperLimit': '25.4'}]}]}, {'title': 'A/New York/55/2004 Post-Dose 1', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '15.7', 'upperLimit': '29.3'}, {'value': '65.6', 'groupId': 'OG001', 'lowerLimit': '47.7', 'upperLimit': '90.2'}]}]}, {'title': 'B/Jiangsu/310/2003 Post-Dose 1', 'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000', 'lowerLimit': '9.89', 'upperLimit': '17.6'}, {'value': '6.2', 'groupId': 'OG001', 'lowerLimit': '5.27', 'upperLimit': '7.29'}]}]}, {'title': 'A/New Caledonia/20/99 Post-Dose 2', 'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000', 'lowerLimit': '29.6', 'upperLimit': '49.2'}, {'value': '104', 'groupId': 'OG001', 'lowerLimit': '77.1', 'upperLimit': '139'}]}]}, {'title': 'A/New York/55/2004 Post-Dose 2', 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000', 'lowerLimit': '61.3', 'upperLimit': '102'}, {'value': '277', 'groupId': 'OG001', 'lowerLimit': '223', 'upperLimit': '346'}]}]}, {'title': 'B/Jiangsu/310/2003 Post-Dose 2', 'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '26.6'}, {'value': '23.9', 'groupId': 'OG001', 'lowerLimit': '18.2', 'upperLimit': '31.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28 Post-vaccination', 'description': 'Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric Mean Titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone® Vaccine-Primed Group', 'description': 'Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.'}, {'id': 'OG001', 'title': 'Influenza Vaccine-Naive Group', 'description': 'Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.'}], 'classes': [{'title': 'Pertussis Toxoid (EU/mL)', 'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000', 'lowerLimit': '47.9', 'upperLimit': '69.9'}, {'value': '69.5', 'groupId': 'OG001', 'lowerLimit': '57.6', 'upperLimit': '83.7'}]}]}, {'title': 'Filamentous Hemagglutinin (EU/mL)', 'categories': [{'measurements': [{'value': '37.3', 'groupId': 'OG000', 'lowerLimit': '29.5', 'upperLimit': '47.1'}, {'value': '47.3', 'groupId': 'OG001', 'lowerLimit': '37.9', 'upperLimit': '59.0'}]}]}, {'title': 'Pertactin (EU/mL)', 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '16.8', 'upperLimit': '28.8'}, {'value': '33.6', 'groupId': 'OG001', 'lowerLimit': '26.1', 'upperLimit': '43.2'}]}]}, {'title': 'Fimbriae Types 2 and 3 (EU/mL)', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000', 'lowerLimit': '18.1', 'upperLimit': '39.5'}, {'value': '11.6', 'groupId': 'OG001', 'lowerLimit': '7.76', 'upperLimit': '17.4'}]}]}, {'title': 'Diphtheria (IU/mL)', 'categories': [{'measurements': [{'value': '0.230', 'groupId': 'OG000', 'lowerLimit': '0.180', 'upperLimit': '0.294'}, {'value': '0.251', 'groupId': 'OG001', 'lowerLimit': '0.191', 'upperLimit': '0.329'}]}]}, {'title': 'Tetanus (IU/mL)', 'categories': [{'measurements': [{'value': '0.976', 'groupId': 'OG000', 'lowerLimit': '0.694', 'upperLimit': '1.37'}, {'value': '0.980', 'groupId': 'OG001', 'lowerLimit': '0.720', 'upperLimit': '1.33'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28 Post-vaccination', 'description': 'Antibodies against Pertussis, Tetanus, and Haemophilus influenzae antigens were determined by an indirect Enzyme linked immunosorbent assay (ELISA).\n\nAnti-diphtheria antibody response was measured by the Vero Cells - diphtheria toxin challenge method.\n\nThe serological determinations of total anti-PRP antibody was performed using a Farr-type radioimmunoassay.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'GMTs to the Pertussis, Tetanus, Diphtheria and Haemophilus Influenzae antigens were assessed in the per-protocol immunogenicity population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone® Vaccine-Primed Group', 'description': 'Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.'}, {'id': 'OG001', 'title': 'Influenza Vaccine-Naive Group', 'description': 'Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.'}], 'classes': [{'title': 'Polyribosylribitol Phosphate (mcg/mL)', 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.16', 'upperLimit': '2.46'}, {'value': '2.12', 'groupId': 'OG001', 'lowerLimit': '1.49', 'upperLimit': '3.02'}]}]}, {'title': 'Pneumococcal 4 (mcg/mL)', 'categories': [{'measurements': [{'value': '1.02', 'groupId': 'OG000', 'lowerLimit': '0.854', 'upperLimit': '1.22'}, {'value': '0.956', 'groupId': 'OG001', 'lowerLimit': '0.781', 'upperLimit': '1.17'}]}]}, {'title': 'Pneumococcal 6B (mcg/mL)', 'categories': [{'measurements': [{'value': '1.14', 'groupId': 'OG000', 'lowerLimit': '0.906', 'upperLimit': '1.44'}, {'value': '1.24', 'groupId': 'OG001', 'lowerLimit': '0.949', 'upperLimit': '1.61'}]}]}, {'title': 'Pneumococcal 9V (mcg/mL)', 'categories': [{'measurements': [{'value': '0.974', 'groupId': 'OG000', 'lowerLimit': '0.812', 'upperLimit': '1.17'}, {'value': '1.20', 'groupId': 'OG001', 'lowerLimit': '0.981', 'upperLimit': '1.46'}]}]}, {'title': 'Pneumococcal 14 (mcg/mL)', 'categories': [{'measurements': [{'value': '4.98', 'groupId': 'OG000', 'lowerLimit': '4.12', 'upperLimit': '6.03'}, {'value': '5.54', 'groupId': 'OG001', 'lowerLimit': '4.56', 'upperLimit': '6.74'}]}]}, {'title': 'Pneumococcal 18C (mcg/mL)', 'categories': [{'measurements': [{'value': '0.783', 'groupId': 'OG000', 'lowerLimit': '0.646', 'upperLimit': '0.950'}, {'value': '0.790', 'groupId': 'OG001', 'lowerLimit': '0.644', 'upperLimit': '0.970'}]}]}, {'title': 'Pneumococcal 19F (mcg/mL)', 'categories': [{'measurements': [{'value': '1.49', 'groupId': 'OG000', 'lowerLimit': '1.27', 'upperLimit': '1.74'}, {'value': '1.26', 'groupId': 'OG001', 'lowerLimit': '1.05', 'upperLimit': '1.51'}]}]}, {'title': 'Pneumococcal 23F (mcg/mL)', 'categories': [{'measurements': [{'value': '0.920', 'groupId': 'OG000', 'lowerLimit': '0.737', 'upperLimit': '1.15'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.779', 'upperLimit': '1.29'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28 post-vaccination', 'description': 'Human antibodies to Streptococcus pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were determined by an Enzyme linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal antibodies were determined in the per-protocol population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone® Vaccine-Primed Group', 'description': 'Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.'}, {'id': 'OG001', 'title': 'Influenza Vaccine-Naive Group', 'description': 'Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.'}], 'classes': [{'title': 'Polio Type 1 (1/dil)', 'categories': [{'measurements': [{'value': '555', 'groupId': 'OG000', 'lowerLimit': '415', 'upperLimit': '742'}, {'value': '1072', 'groupId': 'OG001', 'lowerLimit': '814', 'upperLimit': '1411'}]}]}, {'title': 'Polio Type 2 (1/dil)', 'categories': [{'measurements': [{'value': '356', 'groupId': 'OG000', 'lowerLimit': '268', 'upperLimit': '474'}, {'value': '550', 'groupId': 'OG001', 'lowerLimit': '411', 'upperLimit': '736'}]}]}, {'title': 'Polio Type 3 (1/dil)', 'categories': [{'measurements': [{'value': '394', 'groupId': 'OG000', 'lowerLimit': '282', 'upperLimit': '551'}, {'value': '571', 'groupId': 'OG001', 'lowerLimit': '397', 'upperLimit': '822'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28 post-vaccination', 'description': 'Antibodies to polio viruses were measured by a serum neutralization assay.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric Mean Titers (GMTs) for the Polio antibodies were determined in the per-protocol population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone® Vaccine-Primed Group', 'description': 'Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.'}, {'id': 'OG001', 'title': 'Influenza Vaccine-Naive Group', 'description': 'Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.'}], 'classes': [{'title': 'Any Solicited Injection Site Reaction Post-Dose 1', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Any Tenderness', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Grd 3 Tenderness (injected limb movement reduced)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness (> 0.5 cm)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness (≥ 5.0 cm)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling (> 0.5 cm)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling (≥ 5.0 cm)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Solicited Injection Site Reaction Post-Dose 2', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Any Tenderness', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Grd 3 Tenderness (injected limb movement reduced)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness (> 0.5 cm)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness ≥ 5.0 cm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling (> 0.5 cm)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling (≥ 5.0 cm)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Solicited Injection Site Reaction - Any Dose', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Any Tenderness', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Grd 3 Tenderness (injected limb movement reduced)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness (> 0.5 cm)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness (≥ 5.0 cm)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling (> 0.5 cm)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling (≥ 5.0 cm)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Solicited Systemic Reaction Post-Dose 1', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever ≥ 103.3 ºF)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Vomiting', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Vomiting (≥ 6 episodes per 24 hours)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Abnormal Crying', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Abnormal Crying (> 3 hours)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness (difficulty waking up)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of Appetite', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Grd 3 Loss of Appetite (refuses ≥ 3 or most feeds)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability (inconsolable)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Solicited Systemic Reaction Post-Dose 2', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever (≥ 103.3 ºF)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Vomiting', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Vomiting (≥ 6 episodes per 24 hours)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Abnormal Crying', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Abnormal Crying (> 3 hours)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness (difficulty waking up)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of Appetite', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Grd 3 Loss of Appetite (refuses ≥ 3 or most feeds)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability (inconsolable)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Solicited Systemic Reaction - Any Dose', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever (≥ 103.3 ºF)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Vomiting', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Vomiting (≥ 6 episodes per 24 hours)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Abnormal Crying', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Abnormal Crying (> 3 hours)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness (difficulty waking up)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of Appetite', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Grd 3 Loss of Appetite (refuses ≥ 3 or most feeds)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability (inconsolable)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 up to 7 post-vaccination', 'description': 'Solicited injection site reactions: Tenderness, erythema and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluzone® Vaccine-Primed Group', 'description': 'Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.'}, {'id': 'FG001', 'title': 'Influenza Vaccine-Naive Group', 'description': 'Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '130'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 17 October 2005 to 05 January 2006 at 7 medical centers in the US.', 'preAssignmentDetails': 'A total of 242 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluzone® Vaccine-Primed Group', 'description': 'Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.'}, {'id': 'BG001', 'title': 'Influenza Vaccine-Naive Group', 'description': 'Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.29', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '7.28', 'spread': '1.47', 'groupId': 'BG001'}, {'value': '7.28', 'spread': '1.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-12', 'studyFirstSubmitDate': '2009-04-20', 'resultsFirstSubmitDate': '2009-09-02', 'studyFirstSubmitQcDate': '2009-04-20', 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-12-03', 'studyFirstPostDateStruct': {'date': '2009-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine.', 'timeFrame': 'Day 28 Post-vaccination', 'description': 'Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.'}, {'measure': 'Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine.', 'timeFrame': 'Day 28 Post-vaccination', 'description': 'Antibodies against Pertussis, Tetanus, and Haemophilus influenzae antigens were determined by an indirect Enzyme linked immunosorbent assay (ELISA).\n\nAnti-diphtheria antibody response was measured by the Vero Cells - diphtheria toxin challenge method.\n\nThe serological determinations of total anti-PRP antibody was performed using a Farr-type radioimmunoassay.'}, {'measure': 'Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine.', 'timeFrame': 'Day 28 post-vaccination', 'description': 'Human antibodies to Streptococcus pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were determined by an Enzyme linked immunosorbent assay (ELISA).'}, {'measure': 'Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine.', 'timeFrame': 'Day 28 post-vaccination', 'description': 'Antibodies to polio viruses were measured by a serum neutralization assay.'}, {'measure': 'Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine.', 'timeFrame': 'Days 0 up to 7 post-vaccination', 'description': 'Solicited injection site reactions: Tenderness, erythema and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.'}], 'primaryOutcomes': [{'measure': 'Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.', 'timeFrame': 'Day 28 Post-vaccination', 'description': 'Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fluzone® vaccine', 'Influenza'], 'conditions': ['Influenza']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine.\n\nObservational Objectives:\n\n* To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination.\n* To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in both study groups following each vaccination.\n* To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in both study groups.', 'detailedDescription': 'This is a descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children who were given Fluzone® vaccine at 2 months of age (Study GRC27 NCT00858468)and those who never received influenza vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant is between 6 and 10 months of age on the day of inclusion (has reached 6-month but has not reached 11-month anniversary of birth).\n* Available for the duration of the study.\n* Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg\n* Parent/legal acceptable representative willing and able to provide informed consent.\n* Parent/legal acceptable representative able to attend all scheduled visits and comply with all trial procedures.\n* Parent/legal acceptable representative willing to permit venipuncture for purposes of collecting a blood sample.\n* Previously enrolled in the 2-month-old group in Study GRC27 or approved by sponsor for enrollment as control.\n\nExclusion Criteria:\n\n* Reported allergy to egg proteins, chicken proteins, or any other constituent of Fluzone vacccine.\n* Previous history of influenza vaccination (Group 2 subjects only).\n* Receipt of any vaccine in the 14 days prior to enrollment.\n* An acute illness with or without fever (rectal temperature ≥ 38.0 °C \\[or ≥100.4 °F\\]) in the 72 hours preceding enrollment in the trial.\n* Known bleeding disorder.\n* Participation in any other interventional (e.g., vaccine, drug) clinical trial (except Study GRC27) within 30 days prior to enrollment, or planned participation in another interventional clinical trial prior to termination of the subject's participation in this study.\n* Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.\n* Personal or immediate family history of congenital immune deficiency.\n* Developmental delay, neurologic disorder, or seizure disorder.\n* Chronic medical, congenital or developmental disorder that could interfere with trial conduct or completion.\n* Known human immunodeficiency virus (HIV)-positive or hepatitis B surface antigen (HBsAg)-positive mother.\n* Known HIV, hepatitis B, or hepatitis C infection.\n* Receipt of blood or blood-derived products within the past 2 months.\n* Prior history of Guillain-Barré syndrome.\n* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine."}, 'identificationModule': {'nctId': 'NCT00885105', 'briefTitle': 'Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Evaluation of Serologic Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® Vaccine at 2 Months of Age', 'orgStudyIdInfo': {'id': 'GRC32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluzone® Vaccine-Primed Group', 'description': 'Participants received 2 doses of Fluzone® vaccine at 2 months (in Study GRC 27)', 'interventionNames': ['Biological: Influenza Virus Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Influenza Vaccine-Naive Group', 'description': 'Participants who have never received influenza vaccine (and not in Study GRC27)', 'interventionNames': ['Biological: Influenza Virus Vaccine']}], 'interventions': [{'name': 'Influenza Virus Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone® 2005-2006 Pediatric Formulation'], 'description': '0.25 mL, Intramuscular', 'armGroupLabels': ['Fluzone® Vaccine-Primed Group']}, {'name': 'Influenza Virus Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone® 2005-2006 Pediatric Formulation'], 'description': '0.25 mL, Intramuscular', 'armGroupLabels': ['Influenza Vaccine-Naive Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '30062', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45404', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '98040', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}