Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-16 @ 7:12 PM
Study NCT ID:
NCT00561002
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2007-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': '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 events data were collected from the day of vaccination for 14 days post-vaccination (Influenza Vaccine Primed group) or 42 days post-vaccination (Influenza Vaccine Naïve/Inadequately Primed group)', 'eventGroups': [{'id': 'EG000', 'title': 'Influenza Vaccine Naive/Inadequately Primed', 'description': 'Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.', 'otherNumAtRisk': 23, 'otherNumAffected': 12, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Influenza Vaccine Primed', 'description': 'Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.', 'otherNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine Naive/Inadequately Primed', 'description': 'Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.'}, {'id': 'OG001', 'title': 'Influenza Vaccine Primed', 'description': 'Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.'}], 'classes': [{'title': 'Any Solicited Injection Site Reaction Post-dose 1', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any Tenderness', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grd 3 Tenderness (Cries when limb is moved)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grd 3 Pain (Incapacitating)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness (> 0.5 cm)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', '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': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling (≥ 5.0 cm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Solicited Injection Site Reaction Post-dose 2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Tenderness', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grd 3 Tenderness (Cries when limb is moved)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grd 3 Pain (Incapacitating)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness (> 0.5 cm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', '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': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling (≥ 5.0 cm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Solicited Injection Reaction - Any dose', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any Tenderness', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Tenderness (Cries when limb moved)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain (Incapacitating)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness (> 0.5 cm)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', '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': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling (≥ 5.0 cm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Solicited Systemic Reaction Post-dose 1', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever (>103.1 ºF)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Vomiting', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Vomiting (≥ episodes per 24 hr)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Abnormal Crying', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Abnormal Crying (> 3 hr)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness (Sleeps most of the time)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of Appetite', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Loss of Appetite (Refuses most feeds)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability (Inconsolable)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache (Prevents daily activities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia (Prevents daily activities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Malaise', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise (Prevents daily activities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Solicited Systemic Reaction Post-dose 2', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever (> 103ºF)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Vomiting', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Vomiting (≥ 6 episodes per 24 hr)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Abnormal Crying', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Abnormal Crying (>3 hr)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness (Sleeps most of time)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of Appetite', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Loss of Appetite (Refuses most feeds)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability (Inconsolable)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache (Prevents daily activities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia (Prevents daily activities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Malaise', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise (Prevents daily activities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Solicited Systemic Reaction (Any dose)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever (> 103.1 ºF)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Vomiting', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Vomiting (≥ 6 episodes per 24 hr)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Abnormal Crying', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Abnormal Crying (> 3 hr)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness (Sleeps most of the time)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of Appetite', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Loss of Appetite (Refuses most feeds)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability (Inconsolable)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache (Prevents activities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia (Prevents activities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Malaise', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise (Prevents activities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0-3 post-dose', 'description': 'Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine Naive/Inadequately Primed', 'description': 'Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.'}, {'id': 'OG001', 'title': 'Influenza Vaccine Primed', 'description': 'Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.'}], 'classes': [{'title': 'A/Solomon Islands/3/2006 IVR-145 (H1N1) Pre-dose', 'categories': [{'measurements': [{'value': '8.31', 'groupId': 'OG000', 'lowerLimit': '4.48', 'upperLimit': '15.4'}, {'value': '5.61', 'groupId': 'OG001', 'lowerLimit': '4.17', 'upperLimit': '7.55'}]}]}, {'title': 'A/Solomon Islands/3/2006 IVR-145 (H1N1) Post-dose', 'categories': [{'measurements': [{'value': '397', 'groupId': 'OG000', 'lowerLimit': '243', 'upperLimit': '649'}, {'value': '180', 'groupId': 'OG001', 'lowerLimit': '63.1', 'upperLimit': '511'}]}]}, {'title': 'A/Wisconsin/67/2005 (X-161B) (H3N2) Pre-dose', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '5.11', 'upperLimit': '22.5'}, {'value': '59.9', 'groupId': 'OG001', 'lowerLimit': '8.94', 'upperLimit': '402'}]}]}, {'title': 'Wisconsin/67/2005 (X161B) (H3N2) Post-dose', 'categories': [{'measurements': [{'value': '260', 'groupId': 'OG000', 'lowerLimit': '168', 'upperLimit': '401'}, {'value': '479', 'groupId': 'OG001', 'lowerLimit': '200', 'upperLimit': '1148'}]}]}, {'title': 'B/Malaysia Split/2506/2004 Pre-dose', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000', 'lowerLimit': '5.96', 'upperLimit': '25.4'}, {'value': '13.3', 'groupId': 'OG001', 'lowerLimit': '3.92', 'upperLimit': '45.5'}]}]}, {'title': 'B/Malaysia Split/2506/2004 Post-dose', 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000', 'lowerLimit': '72.6', 'upperLimit': '477'}, {'value': '180', 'groupId': 'OG001', 'lowerLimit': '70.2', 'upperLimit': '459'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 and Day 14 after last dose of Fluzone', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Geometric Mean Titers analysis were on the per-protocol immunogenicity population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine Naive/Inadequately Primed', 'description': 'Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.'}, {'id': 'OG001', 'title': 'Influenza Vaccine Primed', 'description': 'Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.'}], 'classes': [{'title': 'A/Solomon Islands/3/2006 IVR-145 (H1N1)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'A/Wisconsin/67/2005 (X-161B) (H3N2)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'B/Malaysia Split/2506/2004', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14 post-vaccination', 'description': 'Seroprotection was defined as a serum hemagglutination inhibition antibody titer ≥40.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The serum hemagglutination inhibition antibody analysis were on the per-protocol immunogenicity population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Seroconversion Rates for Each Influenza Antigen Post-Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine Naive/Inadequately Primed', 'description': 'Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.'}, {'id': 'OG001', 'title': 'Influenza Vaccine Primed', 'description': 'Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.'}], 'classes': [{'title': 'A/Solomon Islands/3/2006 IVR-145 (H1N1)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'A/Wisconsin/67/2005 (X-161B) (H3N2)', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'B/Malaysia Split/2506/2004', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14 post-vaccination', 'description': 'Seroconversion was defined as a post-vaccination titer ≥ 40 for participants with a titer \\< 10 on Day 0 and a ≥4-fold increase for participants with a titer ≥ 10 on Day 0.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The seroconversion analysis were on the per-protocol immunogenicity population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Influenza Vaccine Naive/Inadequately Primed', 'description': 'Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.'}, {'id': 'FG001', 'title': 'Influenza Vaccine Primed', 'description': 'Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study participants were enrolled from 29 October 2007 through 27 November 2007 at 1 US site.', 'preAssignmentDetails': 'A total of 34 participants who met the inclusion and exclusion criteria were enrolled, 2 were not vaccinated and excluded from the analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Influenza Vaccine Naive/Inadequately Primed', 'description': 'Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.'}, {'id': 'BG001', 'title': 'Influenza Vaccine Primed', 'description': 'Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '32', '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': [{'title': 'Age Continuous', 'categories': [{'measurements': [{'value': '19.8', 'spread': '8.76', 'groupId': 'BG000'}, {'value': '24.5', 'spread': '5.10', 'groupId': 'BG001'}, {'value': '21.2', 'spread': '8.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-12', 'studyFirstSubmitDate': '2007-11-19', 'resultsFirstSubmitDate': '2009-07-20', 'studyFirstSubmitQcDate': '2007-11-19', 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-07-20', 'studyFirstPostDateStruct': {'date': '2007-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination', 'timeFrame': 'Day 0 and Day 14 after last dose of Fluzone'}, {'measure': 'Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)', 'timeFrame': 'Day 14 post-vaccination', 'description': 'Seroprotection was defined as a serum hemagglutination inhibition antibody titer ≥40.'}, {'measure': 'Seroconversion Rates for Each Influenza Antigen Post-Vaccination', 'timeFrame': 'Day 14 post-vaccination', 'description': 'Seroconversion was defined as a post-vaccination titer ≥ 40 for participants with a titer \\< 10 on Day 0 and a ≥4-fold increase for participants with a titer ≥ 10 on Day 0.'}], 'primaryOutcomes': [{'measure': 'Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation', 'timeFrame': 'Days 0-3 post-dose', 'description': 'Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza Vaccine', 'Influenza Virus', 'Orthomyxoviridae Infections', 'Fluzone®'], 'conditions': ['Influenza']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2007-2008 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '35 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is aged ≥ 6 months (24 weeks) to \\< 36 months (3rd birthday).\n* Participant is considered to be in good health on the basis of reported medical history and limited physical examination.\n* Participant is available for the duration of the study.\n* Parent/legal acceptable representative is willing and able to provide informed consent.\n* Parent/legal acceptable representative is willing and able to meet protocol requirements.\n* Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).\n\nExclusion Criteria:\n\n* Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.\n* An acute illness with or without fever (For infants/toddlers: temperature ≥ 100.4°F rectal; For children: temperature ≥ 99.5°F oral/axillary) in the 72 hours preceding enrollment in the trial (Enrollment may be deferred).\n* Clinically significant findings in vital signs or review of systems (Investigator judgment; defer or exclude).\n* Participation in any other interventional clinical trial within 30 days prior to enrollment or planned participation in the 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.\n* Known human immunodeficiency virus (HIV)-positive mother.\n* Prior personal 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.\n* Received any vaccinations within the preceding 14 days (enrollment may be deferred).'}, 'identificationModule': {'nctId': 'NCT00561002', 'briefTitle': 'Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2007-2008 Formulation)', 'orgStudyIdInfo': {'id': 'GRC38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Influenza vaccine Naive/Inadequately Primed', 'description': 'Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.', 'interventionNames': ['Biological: 2007-2008 Influenza Virus Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Influenza Vaccine Primed', 'description': 'Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.', 'interventionNames': ['Biological: 2007-2008 Influenza Virus Vaccine']}], 'interventions': [{'name': '2007-2008 Influenza Virus Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone®'], 'description': '0.25 mL, Intramuscular', 'armGroupLabels': ['Influenza vaccine Naive/Inadequately Primed']}, {'name': '2007-2008 Influenza Virus Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone®'], 'description': '0.25 mL, Intramuscular', 'armGroupLabels': ['Influenza Vaccine Primed']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}