Viewing Study NCT05062759

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Ignite Creation Date: 2025-12-24 @ 2:28 PM
Ignite Modification Date: 2025-12-25 @ 8:20 PM
Study NCT ID: NCT05062759
Status: COMPLETED
Last Update Posted: 2023-06-22
First Post: 2021-08-23
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With Asthma
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000622721', 'term': 'tezepelumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '+187724094 79', 'title': 'Global Clinical Head', 'organization': 'AstraZeneca Clinical Study Information Center'}, 'certainAgreement': {'otherDetails': 'This document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)', 'eventGroups': [{'id': 'EG000', 'title': 'Tezepelumab', 'description': 'Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 14, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 15, 'seriousNumAtRisk': 35, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Stab wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-vaccination Strain-specific Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rises (GMFRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab', 'description': 'Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS'}], 'classes': [{'title': 'Influenza A H1N1', 'categories': [{'measurements': [{'value': '7.34', 'spread': '1.361', 'groupId': 'OG000', 'lowerLimit': '1.361'}, {'value': '4.75', 'spread': '1.455', 'groupId': 'OG001', 'lowerLimit': '1.455'}]}]}, {'title': 'Influenza B Yamagata Lineage', 'categories': [{'measurements': [{'value': '1.76', 'spread': '0.955', 'groupId': 'OG000', 'lowerLimit': '0.955'}, {'value': '1.46', 'spread': '0.937', 'groupId': 'OG001', 'lowerLimit': '0.937'}]}]}, {'title': 'Influenza B Victoria Lineage', 'categories': [{'measurements': [{'value': '2.94', 'spread': '1.054', 'groupId': 'OG000', 'lowerLimit': '1.054'}, {'value': '2.90', 'spread': '0.841', 'groupId': 'OG001', 'lowerLimit': '0.841'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least square (LS) mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.65', 'ciLowerLimit': '0.43', 'ciUpperLimit': '0.98', 'groupDescription': 'Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometeric LS mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.83', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.15', 'groupDescription': 'Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.99', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.37', 'groupDescription': 'Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From Week 12 to Week 16', 'description': 'Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.\n\nHAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.', 'unitOfMeasure': 'Fold change', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or Microneutralization antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.'}, {'type': 'PRIMARY', 'title': 'Post-vaccination Strain-specific Microneutralization (MN) Antibody GMFRs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab', 'description': 'Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS'}], 'classes': [{'title': 'Influenza A H1N1', 'categories': [{'measurements': [{'value': '14.56', 'spread': '2.581', 'groupId': 'OG000', 'lowerLimit': '2.581'}, {'value': '10.62', 'spread': '2.409', 'groupId': 'OG001', 'lowerLimit': '2.409'}]}]}, {'title': 'Influenza A H3N2', 'categories': [{'measurements': [{'value': '4.73', 'spread': '1.509', 'groupId': 'OG000', 'lowerLimit': '1.509'}, {'value': '5.90', 'spread': '3.180', 'groupId': 'OG001', 'lowerLimit': '3.180'}]}]}, {'title': 'Influenza B Yamagata Lineage', 'categories': [{'measurements': [{'value': '4.00', 'spread': '1.541', 'groupId': 'OG000', 'lowerLimit': '1.541'}, {'value': '3.56', 'spread': '2.206', 'groupId': 'OG001', 'lowerLimit': '2.206'}]}]}, {'title': 'Influenza B Victoria Lineage', 'categories': [{'measurements': [{'value': '4.08', 'spread': '2.279', 'groupId': 'OG000', 'lowerLimit': '2.279'}, {'value': '5.04', 'spread': '1.723', 'groupId': 'OG001', 'lowerLimit': '1.723'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometeric LS mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.73', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.28', 'groupDescription': 'Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometeric LS mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.25', 'ciLowerLimit': '0.72', 'ciUpperLimit': '2.17', 'groupDescription': 'Influenza A H3N2 Ratio of placebo over tezepelumab. Results based on ANCOVA model', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.23', 'ciLowerLimit': '0.73', 'ciUpperLimit': '2.07', 'groupDescription': 'Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometeric LS mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.89', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.48', 'groupDescription': 'Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From Week 12 to Week 16', 'description': 'Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.', 'unitOfMeasure': 'Fold change', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.'}, {'type': 'PRIMARY', 'title': 'Post-vaccination Strain-specific Serum HAI Antibody Geometric Mean Titers (GMTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab', 'description': 'Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS'}], 'classes': [{'title': 'Influenza A H1N1', 'categories': [{'measurements': [{'value': '809.23', 'spread': '0.921', 'groupId': 'OG000', 'lowerLimit': '0.921'}, {'value': '596.76', 'spread': '1.076', 'groupId': 'OG001', 'lowerLimit': '1.076'}]}]}, {'title': 'Influenza B Yamagata Lineage', 'categories': [{'measurements': [{'value': '167.46', 'spread': '0.925', 'groupId': 'OG000', 'lowerLimit': '0.925'}, {'value': '161.56', 'spread': '0.688', 'groupId': 'OG001', 'lowerLimit': '0.688'}]}]}, {'title': 'Influenza B Victoria Lineage', 'categories': [{'measurements': [{'value': '194.68', 'spread': '1.089', 'groupId': 'OG000', 'lowerLimit': '1.089'}, {'value': '200.55', 'spread': '0.948', 'groupId': 'OG001', 'lowerLimit': '0.948'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometeric LS mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.74', 'ciLowerLimit': '0.52', 'ciUpperLimit': '1.04', 'groupDescription': 'Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometeric LS mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.96', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.29', 'groupDescription': 'Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.03', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.46', 'groupDescription': 'Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 16', 'description': 'Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.\n\nHAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.', 'unitOfMeasure': 'Titer', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.'}, {'type': 'PRIMARY', 'title': 'Post-vaccination Strain-specific Serum MN Antibody GMTs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab', 'description': 'Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS'}], 'classes': [{'title': 'Influenza A H1N1', 'categories': [{'measurements': [{'value': '382.55', 'spread': '1.469', 'groupId': 'OG000', 'lowerLimit': '1.469'}, {'value': '303.63', 'spread': '1.667', 'groupId': 'OG001', 'lowerLimit': '1.667'}]}]}, {'title': 'Influenza A H3N2', 'categories': [{'measurements': [{'value': '600.92', 'spread': '2.154', 'groupId': 'OG000', 'lowerLimit': '2.154'}, {'value': '457.33', 'spread': '2.336', 'groupId': 'OG001', 'lowerLimit': '2.336'}]}]}, {'title': 'Influenza B Yamagata Lineage', 'categories': [{'measurements': [{'value': '355.44', 'spread': '1.076', 'groupId': 'OG000', 'lowerLimit': '1.076'}, {'value': '366.81', 'spread': '1.270', 'groupId': 'OG001', 'lowerLimit': '1.270'}]}]}, {'title': 'Influenza B Victoria Lineage', 'categories': [{'measurements': [{'value': '125.67', 'spread': '4.687', 'groupId': 'OG000', 'lowerLimit': '4.687'}, {'value': '124.35', 'spread': '3.515', 'groupId': 'OG001', 'lowerLimit': '3.515'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometeric LS mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.79', 'ciLowerLimit': '0.51', 'ciUpperLimit': '1.25', 'groupDescription': 'Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometeric LS mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.76', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.28', 'groupDescription': 'Influenza A H3N2 Ratio of placebo over tezepelumab. Results based on ANCOVA model', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.99', 'ciLowerLimit': '0.49', 'ciUpperLimit': '1.99', 'groupDescription': 'Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometeric LS mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.03', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.52', 'groupDescription': 'Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 16', 'description': 'Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.', 'unitOfMeasure': 'Titer', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in HAI Antibody Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab', 'description': 'Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS'}], 'classes': [{'title': 'Influenza A H1N1', 'categories': [{'measurements': [{'value': '78.8', 'spread': '63.82', 'groupId': 'OG000', 'lowerLimit': '63.82', 'upperLimit': '89.60'}, {'value': '51.5', 'spread': '36.07', 'groupId': 'OG001', 'lowerLimit': '36.07', 'upperLimit': '66.74'}]}]}, {'title': 'Influenza B Yamagata Lineage', 'categories': [{'measurements': [{'value': '15.2', 'spread': '6.17', 'groupId': 'OG000', 'lowerLimit': '6.17', 'upperLimit': '29.25'}, {'value': '15.2', 'spread': '6.17', 'groupId': 'OG001', 'lowerLimit': '6.17', 'upperLimit': '29.25'}]}]}, {'title': 'Influenza B Victoria Lineage', 'categories': [{'measurements': [{'value': '30.3', 'spread': '17.46', 'groupId': 'OG000', 'lowerLimit': '17.46', 'upperLimit': '45.96'}, {'value': '39.4', 'spread': '25.11', 'groupId': 'OG001', 'lowerLimit': '25.11', 'upperLimit': '55.18'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.\n\nHAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in MN Antibody Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab', 'description': 'Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS'}], 'classes': [{'title': 'Influenza A H1N1', 'categories': [{'measurements': [{'value': '81.8', 'spread': '67.24', 'groupId': 'OG000', 'lowerLimit': '67.24', 'upperLimit': '91.77'}, {'value': '75.8', 'spread': '60.49', 'groupId': 'OG001', 'lowerLimit': '60.49', 'upperLimit': '87.32'}]}]}, {'title': 'Influenza A H3N2', 'categories': [{'measurements': [{'value': '60.6', 'spread': '44.82', 'groupId': 'OG000', 'lowerLimit': '44.82', 'upperLimit': '74.89'}, {'value': '51.5', 'spread': '36.07', 'groupId': 'OG001', 'lowerLimit': '36.07', 'upperLimit': '66.74'}]}]}, {'title': 'Influenza B Yamagata Lineage', 'categories': [{'measurements': [{'value': '51.5', 'spread': '36.07', 'groupId': 'OG000', 'lowerLimit': '36.07', 'upperLimit': '66.74'}, {'value': '36.4', 'spread': '22.50', 'groupId': 'OG001', 'lowerLimit': '22.50', 'upperLimit': '52.16'}]}]}, {'title': 'Influenza B Victoria Lineage', 'categories': [{'measurements': [{'value': '54.5', 'spread': '38.94', 'groupId': 'OG000', 'lowerLimit': '38.94', 'upperLimit': '69.51'}, {'value': '63.6', 'spread': '47.84', 'groupId': 'OG001', 'lowerLimit': '47.84', 'upperLimit': '77.50'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.\n\nVaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients With Post-vaccination Strain-specific HAI Antibody Titer ≥ 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab', 'description': 'Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS'}], 'classes': [{'title': 'Influenza A H1N1', 'categories': [{'measurements': [{'value': '100', 'spread': '91.32', 'groupId': 'OG000', 'lowerLimit': '91.32', 'upperLimit': '100.00'}, {'value': '100', 'spread': '91.32', 'groupId': 'OG001', 'lowerLimit': '91.32', 'upperLimit': '100.00'}]}]}, {'title': 'Influenza B Yamagata Lineage', 'categories': [{'measurements': [{'value': '97', 'spread': '86.41', 'groupId': 'OG000', 'lowerLimit': '86.41', 'upperLimit': '99.84'}, {'value': '100', 'spread': '91.32', 'groupId': 'OG001', 'lowerLimit': '91.32', 'upperLimit': '100.00'}]}]}, {'title': 'Influenza B Victoria Lineage', 'categories': [{'measurements': [{'value': '100', 'spread': '91.32', 'groupId': 'OG000', 'lowerLimit': '91.32', 'upperLimit': '100.00'}, {'value': '97.0', 'spread': '86.41', 'groupId': 'OG001', 'lowerLimit': '86.41', 'upperLimit': '99.84'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.\n\nHAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients With Post-vaccination Strain-specific MN Antibody Titer ≥ 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab', 'description': 'Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS'}], 'classes': [{'title': 'Influenza A H1N1', 'categories': [{'measurements': [{'value': '100', 'spread': '91.32', 'groupId': 'OG000', 'lowerLimit': '91.32', 'upperLimit': '100.00'}, {'value': '93.9', 'spread': '82.13', 'groupId': 'OG001', 'lowerLimit': '82.13', 'upperLimit': '98.91'}]}]}, {'title': 'Influenza A H3N2', 'categories': [{'measurements': [{'value': '93.9', 'spread': '82.13', 'groupId': 'OG000', 'lowerLimit': '82.13', 'upperLimit': '98.91'}, {'value': '97', 'spread': '86.41', 'groupId': 'OG001', 'lowerLimit': '86.41', 'upperLimit': '99.84'}]}]}, {'title': 'Influenza B Yamagata Lineage', 'categories': [{'measurements': [{'value': '97', 'spread': '86.41', 'groupId': 'OG000', 'lowerLimit': '86.41', 'upperLimit': '99.84'}, {'value': '100', 'spread': '91.32', 'groupId': 'OG001', 'lowerLimit': '91.32', 'upperLimit': '100.00'}]}]}, {'title': 'Influenza B Victoria Lineage', 'categories': [{'measurements': [{'value': '78.8', 'spread': '63.82', 'groupId': 'OG000', 'lowerLimit': '63.82', 'upperLimit': '89.60'}, {'value': '81.8', 'spread': '67.24', 'groupId': 'OG001', 'lowerLimit': '67.24', 'upperLimit': '91.77'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.'}, {'type': 'SECONDARY', 'title': 'Serum Tezepelumab Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab', 'description': 'Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not calculable as 31 of 32 participants had concentrations below lower limit of quantification (0.010 ug/ml). The remaining participant had serum concentration of 0.0235 ug/ml.', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.00', 'spread': '0.5421', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.76', 'spread': '3.6969', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.79', 'spread': '1.0705', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, Week 12, Week 16 and Week 28', 'description': 'Tezepelumab serum concentrations were summarized using descriptive statistics at each visit.', 'unitOfMeasure': 'microgram/milliliter (μg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis set consisted of all patients who received tezepelumab and from whom PK blood samples were obtained and assumed not to be affected by factors such as protocol deviations.\n\nHere, Number of patients analyzed in each row reflects number of patients analyzed for that timepoint'}, {'type': 'SECONDARY', 'title': 'Immunogenicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tezepelumab', 'description': 'Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS'}], 'classes': [{'title': 'ADA prevalence', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Only baseline ADA positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Both baseline and post-baseline ADA positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any baseline ADA positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any post-baseline ADA positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-induced ADA positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'ADA persistently positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'ADA transiently positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-boosted ADA positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TE-ADA positive (ADA incidence)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to Week 28', 'description': 'Immunogenicity assessments were performed. ADA prevalence was defined as patients who are ADA positive at any time including baseline. Persistently positive was defined as having at least two post-baseline ADA positive measurements (with ≥16 weeks between first and last positive) or an ADA positive result at the last available post-baseline assessment. Transiently positive was defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Treatment boosted ADA was defined as baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment. Treatment emergent ADA (ADA incidence) was defined as the sum of treatment induced ADA and treatment boosted ADA.', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set consisted of all patients who received at least 1 dose of study intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tezepelumab', 'description': 'Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted in 15 study centres in the United States between 23 August 2021 and 18 July 2022.', 'preAssignmentDetails': 'The Screening period was 2 to 3 weeks before randomisation. Patients were randomised in a 1:1 ratio to receive tezepelumab or placebo. All the study assessments were performed as per the Schedule of Activities.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tezepelumab', 'description': 'Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '16.6', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '16.5', 'spread': '3.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': 'In utero', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Preterm newborn infants (gestational age < 37 wks)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Newborns (0-27 days)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Infants and toddlers (28 days-23 months)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Children (2-11 years)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Adolescents (12-17 years)', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Adults (18-64 years)', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'From 65-84 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '85 years and over', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All patients randomised and receiving any study intervention were included in the Full analysis set, irrespective of their CSP adherence and continued participation in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-22', 'size': 2297829, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-09T11:25', 'hasProtocol': True}, {'date': '2022-03-24', 'size': 706001, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-09T11:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Neither the participant nor any of the investigators or sponsor staff who are involved in the treatment or clinical evaluation and monitoring of the participants will be aware of the treatment received. Since tezepelumab and placebo are not visually distinct, study intervention will be handled by a qualified person (eg, pharmacist or study nurse) at the site.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-20', 'studyFirstSubmitDate': '2021-08-23', 'resultsFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2021-09-21', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-14', 'studyFirstPostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-vaccination Strain-specific Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rises (GMFRs)', 'timeFrame': 'From Week 12 to Week 16', 'description': 'Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.\n\nHAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.'}, {'measure': 'Post-vaccination Strain-specific Microneutralization (MN) Antibody GMFRs', 'timeFrame': 'From Week 12 to Week 16', 'description': 'Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.'}, {'measure': 'Post-vaccination Strain-specific Serum HAI Antibody Geometric Mean Titers (GMTs)', 'timeFrame': 'Week 16', 'description': 'Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.\n\nHAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.'}, {'measure': 'Post-vaccination Strain-specific Serum MN Antibody GMTs', 'timeFrame': 'Week 16', 'description': 'Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.'}, {'measure': 'Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in HAI Antibody Titer', 'timeFrame': 'Week 16', 'description': 'Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.\n\nHAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.'}, {'measure': 'Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in MN Antibody Titer', 'timeFrame': 'Week 16', 'description': 'Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.\n\nVaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.'}, {'measure': 'Percentage of Patients With Post-vaccination Strain-specific HAI Antibody Titer ≥ 40', 'timeFrame': 'Week 16', 'description': 'Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.\n\nHAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.'}, {'measure': 'Percentage of Patients With Post-vaccination Strain-specific MN Antibody Titer ≥ 40', 'timeFrame': 'Week 16', 'description': 'Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.'}], 'secondaryOutcomes': [{'measure': 'Serum Tezepelumab Concentrations', 'timeFrame': 'Week 0, Week 12, Week 16 and Week 28', 'description': 'Tezepelumab serum concentrations were summarized using descriptive statistics at each visit.'}, {'measure': 'Immunogenicity', 'timeFrame': 'From Baseline to Week 28', 'description': 'Immunogenicity assessments were performed. ADA prevalence was defined as patients who are ADA positive at any time including baseline. Persistently positive was defined as having at least two post-baseline ADA positive measurements (with ≥16 weeks between first and last positive) or an ADA positive result at the last available post-baseline assessment. Transiently positive was defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Treatment boosted ADA was defined as baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment. Treatment emergent ADA (ADA incidence) was defined as the sum of treatment induced ADA and treatment boosted ADA.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tezepelumab', 'Humoral Immune Response', 'Quadrivalent Influenza Vaccination', 'Antibody response', 'Subcutaneous'], 'conditions': ['Moderate to Severe Asthma']}, 'referencesModule': {'references': [{'pmid': '38064153', 'type': 'DERIVED', 'citation': 'Cole J, Capala-Szczurko I, Roseti S, Chen C, Caveney S, Aksyuk AA, Streicher K, Ponnarambil S, Colice G. Effect of Tezepelumab on the Humoral Immune Response to Seasonal Quadrivalent Influenza Vaccination in Patients with Moderate to Severe Asthma: The Phase 3b VECTOR Study. Pulm Ther. 2024 Mar;10(1):53-67. doi: 10.1007/s41030-023-00245-9. Epub 2023 Dec 8.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D5180C00031&amp;attachmentIdentifier=30f0d69f-126e-4f79-8bc8-0542f713c2b0&amp;fileName=D5180C00031_CSR_Synopsis_Redacted.pdf&amp;versionIdentifier=', 'label': 'CSR Synopsis\\_Redacted'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 3b, multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of tezepelumab (210 mg subcutaneous \\[SC\\] every 4 weeks \\[Q4W\\]) on antibody responses following seasonal quadrivalent influenza virus vaccination in the fall/winter 2021-2022 in the USA.', 'detailedDescription': 'Participants with moderate to severe asthma will enter the screening period of a minimum of 2 weeks to allow adequate time for all of the eligibility criteria to be evaluated. They will be randomized 1:1 to receive tezepelumab 210 mg or placebo SC Q4W, administered at Weeks 0, 4, 8 and 12. Randomization will be monitored to ensure at least 50% of the randomized participants are between the ages of 12 to 17 years.\n\nParticipants will receive a single dose of inactivated quadrivalent seasonal influenza vaccine intramuscularly at Week 12, prior to the fourth dose of study intervention.\n\nSerum samples for evaluation of antibody response will be drawn at Week 12 (pre-vaccination) and at Week 16 (4 weeks post-vaccination) when humoral response to the vaccination is expected to be fully developed.\n\nThe End of Treatment (EOT) Visit will be conducted at Week 16 and a final Follow-up Visit and the End of Study Visit will be conducted at Week 28.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Documented physician-diagnosed asthma for at least 12 months prior to Visit 1.\n* Morning pre-bronchodilator FEV1 (Forced expiratory volume) of \\> 50% predicted normal value at Visit 1 or Visit 2.\n* Body weight ≥ 40 kg.\n* For women of childbearing potential, a negative urine pregnancy test is required prior to administration of study intervention at Visit 3.\n* Must have 'not well-controlled' asthma.\n\nExclusion Criteria:\n\n* Clinically important pulmonary disease other than asthma.\n* Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment.\n* Life-threatening asthma\n* History of cancer.\n* Allergy to eggs, if egg based influenza vaccine will be administered.\n* History of anaphylaxis to any biologic therapy.\n* Current smokers or participants with smoking history ≥ 10 pack-years and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of \\< 10 pack-years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible.\n* History of alcohol or drug abuse within 12 months prior to the date of informed consent.\n* Major surgery within 8 weeks prior to Visit 1 or planned surgical procedures during the conduct of the study."}, 'identificationModule': {'nctId': 'NCT05062759', 'acronym': 'VECTOR', 'briefTitle': 'Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Potential Effect of Tezepelumab on the Humoral Immune Response to Seasonal Quadrivalent Influenza Vaccination in Adolescent and Young Adult Participants With Moderate to Severe Asthma (VECTOR)', 'orgStudyIdInfo': {'id': 'D5180C00031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tezepelumab', 'description': 'Participants will be randomized to receive tezepelumab 210 mg administered at Weeks 0, 4, 8 and 12. Participants will also receive a single dose of inactivated quadrivalent seasonal influenza vaccine intramuscularly at Week 12, prior to the fourth dose of study intervention.', 'interventionNames': ['Drug: Tezepelumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo to Tezepelumab', 'description': 'Participants will be randomized to receive placebo SC Q4W, administered at Weeks 0, 4, 8 and 12. Participants will also receive a single dose of inactivated quadrivalent seasonal influenza vaccine intramuscularly at Week 12, prior to the fourth dose of study intervention.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tezepelumab', 'type': 'DRUG', 'description': '210 mg SC injection Q4W.', 'armGroupLabels': ['Tezepelumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'SC injection Q4W.', 'armGroupLabels': ['Placebo to Tezepelumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '08225', 'city': 'Northfield', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.37039, 'lon': -74.55015}}, {'zip': '45406', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '43617', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '73034', 'city': 'Edmond', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.65283, 'lon': -97.4781}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '75225', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '75708', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '76712', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53228', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:\n\nhttps://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:\n\nhttps://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.\n\nYes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the de-identified individual patient level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:\n\nhttps://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}