Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-25 @ 4:49 PM
Study NCT ID:
NCT00617851
Status:
COMPLETED
Last Update Posted:
2012-05-08
First Post:
2008-02-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old
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': {'email': 'RegContactVacUS.nvdit@Novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events were collected for 6 months after vaccination. All adverse events were collected for 21 days after vaccination.', 'description': 'Of the 1507 subjects enrolled and randomized in this study, 96 were not included in the safety analysis (82 in the pooled influenza virus vaccine group and 14 in the comparator influenza vaccine group) as they had no safety data. These subjects have been excluded from the safety analysis to avoid underestimating the incidence rates of reactions.', 'eventGroups': [{'id': 'EG000', 'title': 'Influenza Virus Vaccine (Pooled)', 'description': 'One injection of the investigational influenza virus vaccine (all lots pooled)', 'otherNumAtRisk': 1209, 'otherNumAffected': 0, 'seriousNumAtRisk': 1209, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Comparator Influenza Vaccine', 'description': 'One injection of the comparator influenza virus vaccine', 'otherNumAtRisk': 202, 'otherNumAffected': 0, 'seriousNumAtRisk': 202, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'Abortion Induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abortion Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abscess Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Fibroadenoma of Breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Fractured Coccyx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gas Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hysterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Intracranial Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Multi-Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Road Traffic Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Uterine Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs), by Vaccine Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}, {'value': '393', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Virus Vaccine (Lot A)', 'description': 'One injection of lot A of the investigational influenza virus vaccine'}, {'id': 'OG001', 'title': 'Influenza Virus Vaccine (Lot B)', 'description': 'One injection of lot B of the investigational influenza virus vaccine'}, {'id': 'OG002', 'title': 'Influenza Virus Vaccine (Lot C)', 'description': 'One injection of lot C of the investigational influenza virus vaccine'}], 'classes': [{'title': 'Strain A/H1N1', 'categories': [{'measurements': [{'value': '566', 'groupId': 'OG000', 'lowerLimit': '503', 'upperLimit': '637'}, {'value': '518', 'groupId': 'OG001', 'lowerLimit': '461', 'upperLimit': '582'}, {'value': '513', 'groupId': 'OG002', 'lowerLimit': '454', 'upperLimit': '581'}]}]}, {'title': 'Strain A/H3N2', 'categories': [{'measurements': [{'value': '352', 'groupId': 'OG000', 'lowerLimit': '318', 'upperLimit': '390'}, {'value': '313', 'groupId': 'OG001', 'lowerLimit': '282', 'upperLimit': '348'}, {'value': '359', 'groupId': 'OG002', 'lowerLimit': '326', 'upperLimit': '396'}]}]}, {'title': 'Strain B', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '110'}, {'value': '93', 'groupId': 'OG001', 'lowerLimit': '84', 'upperLimit': '104'}, {'value': '86', 'groupId': 'OG002', 'lowerLimit': '77', 'upperLimit': '96'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (A/H1N1 Strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.29', 'estimateComment': 'The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.\n\nSample size calculations were done by means of Nquery Advisor 5.0.', 'groupDescription': 'H01 LotA ≠ LotB versus H1 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% confidence interval (CI) on the geometric mean titer (GMT) ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \\>= 428 subjects per lot was recruited.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of GMTs (A/H1N1 Strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.31', 'estimateComment': 'The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.\n\nSample size calculations were done by means of Nquery Advisor 5.0.', 'groupDescription': 'H02 LotA ≠ LotC versus H12 LotA = Lotc H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \\>= 428 subjects per lot was recruited.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of GMTs (A/H1N1 Strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.2', 'estimateComment': 'The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.\n\nSample size calculations were done by means of Nquery Advisor 5.0.', 'groupDescription': 'H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \\>= 428 subjects per lot was recruited.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (A/H3N2 Strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.3', 'estimateComment': 'The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.\n\nSample size calculations were done by means of Nquery Advisor 5.0.', 'groupDescription': 'H03 LotA ≠ LotB versus H13 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \\>= 428 subjects per lot was recruited.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of GMTs (A/H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.13', 'estimateComment': 'The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.\n\nSample size calculations were done by means of Nquery Advisor 5.0.', 'groupDescription': 'H03 LotA ≠ LotC versus H13 LotA = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \\>= 428 subjects per lot was recruited.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of GMTs (A/H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.01', 'estimateComment': 'The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.\n\nSample size calculations were done by means of Nquery Advisor 5.0.', 'groupDescription': 'H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \\>= 428 subjects per lot was recruited.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.23', 'estimateComment': 'The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.\n\nSample size calculations were done by means of Nquery Advisor 5.0.', 'groupDescription': 'H03 LotA ≠ LotB versus H13 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \\>= 428 subjects per lot was recruited.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of GMTs (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.33', 'estimateComment': 'The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.\n\nSample size calculations were done by means of Nquery Advisor 5.0.', 'groupDescription': 'H03 LotA ≠ LotC versus H13 LotA = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \\>= 428 subjects per lot was recruited.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of GMTs (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.26', 'estimateComment': 'The control vaccine arm (n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.\n\nSample size calculations were done by means of Nquery Advisor 5.0.', 'groupDescription': 'H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \\>= 428 subjects per lot was recruited.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '21 days after vaccination', 'description': 'The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the per-protocol population, defined as all subjects enrolled who:\n\n* received all the relevant doses of vaccine correctly, and\n* provided evaluable serum samples at the relevant time points, and\n* had no major protocol deviation'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs), by Vaccine Group and Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1182', 'groupId': 'OG000'}, {'value': '1182', 'groupId': 'OG001'}, {'value': '1182', 'groupId': 'OG002'}, {'value': '194', 'groupId': 'OG003'}, {'value': '194', 'groupId': 'OG004'}, {'value': '194', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Virus Vaccine (Strain A/H1N1)', 'description': 'One injection of the investigational influenza virus vaccine-Strain A/H1N1'}, {'id': 'OG001', 'title': 'Influenza Virus Vaccine (Strain A/H3N2)', 'description': 'One injection of the investigational influenza virus vaccine-Strain A/H3N2'}, {'id': 'OG002', 'title': 'Influenza Virus Vaccine (Strain B)', 'description': 'One injection of the investigational influenza virus vaccine-Strain B'}, {'id': 'OG003', 'title': 'Comparator Influenza Vaccine (Strain A/H1N1)', 'description': 'One injection of the comparator influenza virus vaccine-Strain A/H1N1'}, {'id': 'OG004', 'title': 'Comparator Influenza Vaccine (Strain A/H3N2)', 'description': 'One injection of the comparator influenza virus vaccine-Strain A/H3N2'}, {'id': 'OG005', 'title': 'Comparator Influenza Vaccine (Strain B)', 'description': 'One injection of the comparator influenza virus vaccine-Strain B'}], 'classes': [{'categories': [{'measurements': [{'value': '532', 'groupId': 'OG000', 'lowerLimit': '497', 'upperLimit': '570'}, {'value': '341', 'groupId': 'OG001', 'lowerLimit': '321', 'upperLimit': '361'}, {'value': '93', 'groupId': 'OG002', 'lowerLimit': '87', 'upperLimit': '98'}, {'value': '799', 'groupId': 'OG003', 'lowerLimit': '666', 'upperLimit': '957'}, {'value': '683', 'groupId': 'OG004', 'lowerLimit': '590', 'upperLimit': '790'}, {'value': '99', 'groupId': 'OG005', 'lowerLimit': '85', 'upperLimit': '115'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '21 days after vaccination', 'description': 'The GMTs and 95% CIs were calculated for each of the vaccine group (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each strain.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the per-protocol population, defined as all subjects enrolled who:\n\n* received all the relevant doses of vaccine correctly, and\n* provided evaluable serum samples at the relevant time points, and\n* had no major protocol deviation'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited Local and Systemic Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '1209', 'groupId': 'OG003'}, {'value': '202', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Virus Vaccine (Lot A)', 'description': 'One injection of lot A of the investigational influenza virus vaccine'}, {'id': 'OG001', 'title': 'Influenza Virus Vaccine (Lot B)', 'description': 'One injection of lot B of the investigational influenza virus vaccine'}, {'id': 'OG002', 'title': 'Influenza Virus Vaccine (Lot C)', 'description': 'One injection of lot C of the investigational influenza virus vaccine'}, {'id': 'OG003', 'title': 'Influenza Virus Vaccine (Pooled)', 'description': 'One injection of the investigational influenza virus vaccine (all lots pooled)'}, {'id': 'OG004', 'title': 'Comparator Influenza Vaccine', 'description': 'One injection of the comparator influenza virus vaccine'}], 'classes': [{'title': 'Any Local Reaction', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '310', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}]}, {'title': 'Erythema (mm)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Induration (mm)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}, {'title': 'Swelling (mm)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}, {'title': 'Ecchymosis (mm)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '268', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}]}, {'title': 'Any Systemic Reaction', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '443', 'groupId': 'OG003'}, {'value': '76', 'groupId': 'OG004'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}, {'title': 'Malaise', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '213', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '292', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}]}, {'title': 'Sweating', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}, {'title': 'Fever (≥38C)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after vaccination', 'description': 'Solicited local and systemic reactions were assessed after vaccination for the two vaccines (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each of the three consecutive production lots of the investigational influenza virus vaccine.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the safety population, defined as all subjects who provided post-baseline safety data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With at Least One Unsolicited Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1209', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '403', 'groupId': 'OG002'}, {'value': '404', 'groupId': 'OG003'}, {'value': '402', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Virus Vaccine (Pooled)', 'description': 'One injection of the investigational influenza virus vaccine (all lots pooled)'}, {'id': 'OG001', 'title': 'Comparator Influenza Vaccine', 'description': 'One injection of the comparator influenza virus vaccine'}, {'id': 'OG002', 'title': 'Influenza Virus Vaccine (Lot A)', 'description': 'One injection of lot A of the investigational influenza virus vaccine'}, {'id': 'OG003', 'title': 'Influenza Virus Vaccine (Lot B)', 'description': 'One injection of lot B of the investigational influenza virus vaccine'}, {'id': 'OG004', 'title': 'Influenza Virus Vaccine (Lot C)', 'description': 'One injection of lot C of the investigational influenza virus vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '189', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks after vaccination', 'description': 'Number of subjects reporting at least one unsolicited adverse event, regardless of the assessement of relatedness to the study vaccines (each of the three consecutive production lots of the investigational influenza virus vaccine, the pooled influenza virus vaccine, and the comparator influenza vaccine).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the safety population, defined as all subjects who provided post-baseline safety data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}, {'value': '393', 'groupId': 'OG002'}, {'value': '1182', 'groupId': 'OG003'}, {'value': '194', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Virus Vaccine (Lot A)', 'description': 'One injection of lot A of the investigational influenza virus vaccine'}, {'id': 'OG001', 'title': 'Influenza Virus Vaccine (Lot B)', 'description': 'One injection of lot B of the investigational influenza virus vaccine'}, {'id': 'OG002', 'title': 'Influenza Virus Vaccine (Lot C)', 'description': 'One injection of lot C of the investigational influenza virus vaccine'}, {'id': 'OG003', 'title': 'Influenza Virus Vaccine (Pooled)', 'description': 'One injection of the investigational influenza virus vaccine (all lots pooled)'}, {'id': 'OG004', 'title': 'Comparator Influenza Vaccine', 'description': 'One injection of the comparator influenza virus vaccine'}], 'classes': [{'title': 'Seroprotection (HI titer => 40)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '99'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG002', 'lowerLimit': '96', 'upperLimit': '99'}, {'value': '98', 'groupId': 'OG003', 'lowerLimit': '97', 'upperLimit': '99'}, {'value': '98', 'groupId': 'OG004', 'lowerLimit': '95', 'upperLimit': '99'}]}]}, {'title': 'Seroconversion', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': '97'}, {'value': '94', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '96'}, {'value': '93', 'groupId': 'OG002', 'lowerLimit': '90', 'upperLimit': '95'}, {'value': '94', 'groupId': 'OG003', 'lowerLimit': '93', 'upperLimit': '95'}, {'value': '96', 'groupId': 'OG004', 'lowerLimit': '92', 'upperLimit': '98'}]}]}], 'paramType': 'MEAN', 'timeFrame': '21 days after vaccination', 'description': 'The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:\n\n* the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.\n* the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI\\<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum \\[HI≥10\\]), for HI antibody met or exceeded 40%.', 'unitOfMeasure': 'percentages of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the per-protocol population, defined as all subjects enrolled who:\n\n* received all the relevant doses of vaccine correctly, and\n* provided evaluable serum samples at the relevant time points, and\n* had no major protocol deviation'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}, {'value': '393', 'groupId': 'OG002'}, {'value': '1182', 'groupId': 'OG003'}, {'value': '194', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Virus Vaccine (Lot A)', 'description': 'One injection of lot A of the investigational influenza virus vaccine'}, {'id': 'OG001', 'title': 'Influenza Virus Vaccine (Lot B)', 'description': 'One injection of lot B of the investigational influenza virus vaccine'}, {'id': 'OG002', 'title': 'Influenza Virus Vaccine (Lot C)', 'description': 'One injection of lot C of the investigational influenza virus vaccine'}, {'id': 'OG003', 'title': 'Influenza Virus Vaccine (Pooled)', 'description': 'One injection of the investigational influenza virus vaccine (all lots pooled)'}, {'id': 'OG004', 'title': 'Comparator Influenza Vaccine', 'description': 'One injection of the comparator influenza virus vaccine'}], 'classes': [{'title': 'Seroprotection (HI titer ≥40)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '97', 'upperLimit': '99'}, {'value': '99', 'groupId': 'OG002', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG003', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG004', 'lowerLimit': '97', 'upperLimit': '100'}]}]}, {'title': 'Seroconversion', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '74'}, {'value': '64', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '69'}, {'value': '68', 'groupId': 'OG002', 'lowerLimit': '63', 'upperLimit': '72'}, {'value': '67', 'groupId': 'OG003', 'lowerLimit': '65', 'upperLimit': '70'}, {'value': '84', 'groupId': 'OG004', 'lowerLimit': '78', 'upperLimit': '88'}]}]}], 'paramType': 'MEAN', 'timeFrame': '21 days after vaccination', 'description': 'The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:\n\n* the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.\n* the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI\\<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum \\[HI≥10\\]), for HI antibody met or exceeded 40%.', 'unitOfMeasure': 'percentages of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the per-protocol population, defined as all subjects enrolled who:\n\n* received all the relevant doses of vaccine correctly, and\n* provided evaluable serum samples at the relevant time points, and\n* had no major protocol deviation'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Seroprotection and Seroconversion (Strain B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}, {'value': '393', 'groupId': 'OG002'}, {'value': '1182', 'groupId': 'OG003'}, {'value': '194', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Virus Vaccine (Lot A)', 'description': 'One injection of lot A of the investigational influenza virus vaccine'}, {'id': 'OG001', 'title': 'Influenza Virus Vaccine (Lot B)', 'description': 'One injection of lot B of the investigational influenza virus vaccine'}, {'id': 'OG002', 'title': 'Influenza Virus Vaccine (Lot C)', 'description': 'One injection of lot C of the investigational influenza virus vaccine'}, {'id': 'OG003', 'title': 'Influenza Virus Vaccine (Pooled)', 'description': 'One injection of the investigational influenza virus vaccine (all lots pooled)'}, {'id': 'OG004', 'title': 'Comparator Influenza Vaccine', 'description': 'One injection of the comparator influenza virus vaccine'}], 'classes': [{'title': 'Seroprotection (HI titer ≥40)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '91'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '85', 'upperLimit': '91'}, {'value': '84', 'groupId': 'OG002', 'lowerLimit': '80', 'upperLimit': '87'}, {'value': '87', 'groupId': 'OG003', 'lowerLimit': '85', 'upperLimit': '89'}, {'value': '90', 'groupId': 'OG004', 'lowerLimit': '85', 'upperLimit': '94'}]}]}, {'title': 'Seroconversion', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '88'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '82', 'upperLimit': '89'}, {'value': '81', 'groupId': 'OG002', 'lowerLimit': '76', 'upperLimit': '84'}, {'value': '84', 'groupId': 'OG003', 'lowerLimit': '82', 'upperLimit': '86'}, {'value': '86', 'groupId': 'OG004', 'lowerLimit': '80', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'timeFrame': '21 days after vaccination', 'description': 'The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:\n\n* the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.\n* the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI\\<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum \\[HI≥10\\]), for HI antibody met or exceeded 40%.', 'unitOfMeasure': 'percentages of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the per-protocol population, defined as all subjects enrolled who:\n\n* received all the relevant doses of vaccine correctly, and\n* provided evaluable serum samples at the relevant time points, and\n* had no major protocol deviation'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Influenza Virus Vaccine (Lot A)', 'description': 'One injection of lot A of the investigational influeza virus vaccine'}, {'id': 'FG001', 'title': 'Influenza Virus Vaccine (Lot B)', 'description': 'One injection of lot B of the investigational influeza virus vaccine'}, {'id': 'FG002', 'title': 'Influenza Virus Vaccine (Lot C)', 'description': 'One injection of lot C of the investigational influeza virus vaccine'}, {'id': 'FG003', 'title': 'Comparator Influenza Vaccine', 'description': 'One injection of the comparator influeza virus vaccine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '430'}, {'groupId': 'FG001', 'numSubjects': '431'}, {'groupId': 'FG002', 'numSubjects': '429'}, {'groupId': 'FG003', 'numSubjects': '217'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '383'}, {'groupId': 'FG001', 'numSubjects': '391'}, {'groupId': 'FG002', 'numSubjects': '384'}, {'groupId': 'FG003', 'numSubjects': '192'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'Inappropriate Enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Unable to classify', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited at 1 Center along with a satellite center in the Dominican Republic.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'BG000'}, {'value': '431', 'groupId': 'BG001'}, {'value': '429', 'groupId': 'BG002'}, {'value': '217', 'groupId': 'BG003'}, {'value': '1507', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Influenza Virus Vaccine (Lot A)', 'description': 'One injection of lot A of the investigational influenza virus vaccine'}, {'id': 'BG001', 'title': 'Influenza Virus Vaccine (Lot B)', 'description': 'One injection of lot B of the investigational influenza virus vaccine'}, {'id': 'BG002', 'title': 'Influenza Virus Vaccine (Lot C)', 'description': 'One injection of lot C of the investigational influenza virus vaccine'}, {'id': 'BG003', 'title': 'Comparator Influenza Vaccine', 'description': 'One injection of the comparator influenza virus vaccine'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.1', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '31.2', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '31.3', 'spread': '8.9', 'groupId': 'BG002'}, {'value': '31.3', 'spread': '8.7', 'groupId': 'BG003'}, {'value': '31.2', 'spread': '8.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '309', 'groupId': 'BG000'}, {'value': '306', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}, {'value': '1060', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '447', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Arabic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '421', 'groupId': 'BG000'}, {'value': '418', 'groupId': 'BG001'}, {'value': '418', 'groupId': 'BG002'}, {'value': '214', 'groupId': 'BG003'}, {'value': '1471', 'groupId': 'BG004'}]}]}, {'title': 'Native Amer/Alaskan', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1507}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'dispFirstSubmitDate': '2009-08-06', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-03', 'studyFirstSubmitDate': '2008-02-06', 'dispFirstSubmitQcDate': '2009-08-06', 'resultsFirstSubmitDate': '2010-02-03', 'studyFirstSubmitQcDate': '2008-02-15', 'dispFirstPostDateStruct': {'date': '2009-08-10', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-05-27', 'studyFirstPostDateStruct': {'date': '2008-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs), by Vaccine Lots', 'timeFrame': '21 days after vaccination', 'description': 'The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs), by Vaccine Group and Strain', 'timeFrame': '21 days after vaccination', 'description': 'The GMTs and 95% CIs were calculated for each of the vaccine group (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each strain.'}, {'measure': 'Number of Subjects Reporting Solicited Local and Systemic Symptoms', 'timeFrame': '7 days after vaccination', 'description': 'Solicited local and systemic reactions were assessed after vaccination for the two vaccines (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each of the three consecutive production lots of the investigational influenza virus vaccine.'}, {'measure': 'Number of Subjects With at Least One Unsolicited Adverse Event', 'timeFrame': '3 weeks after vaccination', 'description': 'Number of subjects reporting at least one unsolicited adverse event, regardless of the assessement of relatedness to the study vaccines (each of the three consecutive production lots of the investigational influenza virus vaccine, the pooled influenza virus vaccine, and the comparator influenza vaccine).'}, {'measure': 'Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1)', 'timeFrame': '21 days after vaccination', 'description': 'The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:\n\n* the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.\n* the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI\\<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum \\[HI≥10\\]), for HI antibody met or exceeded 40%.'}, {'measure': 'Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2)', 'timeFrame': '21 days after vaccination', 'description': 'The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:\n\n* the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.\n* the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI\\<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum \\[HI≥10\\]), for HI antibody met or exceeded 40%.'}, {'measure': 'Percentage of Subjects With Seroprotection and Seroconversion (Strain B)', 'timeFrame': '21 days after vaccination', 'description': 'The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:\n\n* the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.\n* the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI\\<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum \\[HI≥10\\]), for HI antibody met or exceeded 40%.'}]}, 'conditionsModule': {'keywords': ['Influenza', 'adults', 'different lots', 'trivalent subunit influenza virus vaccine (IVV)', 'trivalent subunit influenza vaccine'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to show how safe and well tolerated a conventional inactivated subunit influenza vaccine, licensed in many countries outside the United States, is compared to an inactivated influenza vaccine, licensed in the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 to 49 years of age;\n* In good health as determined by medical history and physical examination;\n* Able and willing to provide written informed consent prior to any study procedure;\n* Able to comply with all study procedures and available for all clinic visits scheduled in the study.\n\nExclusion Criteria:\n\n* Any serious disease, such as: cancer, autoimmune disease (including rheumatoid arthritis), advanced arteriosclerotic disease or complicated diabetes mellitus\n* History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials (latex);\n* Known or suspected impairment/alteration of immune function\n* Receipt of an influenza vaccine within 6 months prior to Visit 1;\n* Current drug or alcohol abuse or a history of drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of the study objectives;\n* Laboratory-confirmed influenza disease within 6 months prior to Visit 1"}, 'identificationModule': {'nctId': 'NCT00617851', 'briefTitle': 'Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III, Randomized, Controlled, Observer-Blind, Single-Center Study to Evaluate the Consistency of Three Consecutive Lots of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs in Healthy Subjects Aged 18 to 49 Years', 'orgStudyIdInfo': {'id': 'V71P6'}, 'secondaryIdInfos': [{'id': '13299'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Influenza virus vaccine (lot A)', 'description': 'Lot A of the investigational influenza virus vaccine', 'interventionNames': ['Biological: Lot A of Influenza virus vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Influenza virus vaccine (lot B)', 'description': 'Lot B of the investigational influenza virus vaccine', 'interventionNames': ['Biological: Lot B of Influenza virus vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Influenza virus vaccine (lot C)', 'description': 'Lot C of the investigational influenza virus vaccine', 'interventionNames': ['Biological: Lot C of Influenza virus vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Influenza virus vaccine (pooled)', 'description': 'Pooled data of all three lots (Lot A, B and C) of the investigational influenza virus vaccine', 'interventionNames': ['Biological: All 3 consecutive lots of influenza virus vaccine pooled']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator influenza vaccine', 'description': 'A US licensed influenza virus vaccine', 'interventionNames': ['Biological: Comparator influenza virus vaccine']}], 'interventions': [{'name': 'Lot A of Influenza virus vaccine', 'type': 'BIOLOGICAL', 'description': '1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly', 'armGroupLabels': ['Influenza virus vaccine (lot A)']}, {'name': 'Lot B of Influenza virus vaccine', 'type': 'BIOLOGICAL', 'description': '1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly', 'armGroupLabels': ['Influenza virus vaccine (lot B)']}, {'name': 'Lot C of Influenza virus vaccine', 'type': 'BIOLOGICAL', 'description': '1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly', 'armGroupLabels': ['Influenza virus vaccine (lot C)']}, {'name': 'Comparator influenza virus vaccine', 'type': 'BIOLOGICAL', 'description': '1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly', 'armGroupLabels': ['Comparator influenza vaccine']}, {'name': 'All 3 consecutive lots of influenza virus vaccine pooled', 'type': 'BIOLOGICAL', 'description': '1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly', 'armGroupLabels': ['Influenza virus vaccine (pooled)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Centro de Salud Galvan', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Hosp. Nuestra Sra. Altagracia', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}], 'overallOfficials': [{'name': 'Novartis Vaccines and Diagnostics', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}