Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT04801420
Status:
COMPLETED
Last Update Posted:
2025-11-12
First Post:
2021-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008193', 'term': 'Lyme Disease'}], 'ancestors': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001899', 'term': 'Borrelia Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D017282', 'term': 'Tick-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'phoneExt': '0', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).', 'description': 'Solicited AEs comprised injection site reactions (pain, tenderness, erythema \\[redness\\]), induration \\[hardening\\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: VLA15', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.', 'otherNumAtRisk': 190, 'deathsNumAtRisk': 190, 'otherNumAffected': 178, 'seriousNumAtRisk': 190, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2: VLA15 + Placebo', 'description': 'Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.', 'otherNumAtRisk': 187, 'deathsNumAtRisk': 187, 'otherNumAffected': 179, 'seriousNumAtRisk': 187, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Group 3: Placebo', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.', 'otherNumAtRisk': 208, 'deathsNumAtRisk': 208, 'otherNumAffected': 133, 'seriousNumAtRisk': 208, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Any VLA15', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.', 'otherNumAtRisk': 417, 'deathsNumAtRisk': 417, 'otherNumAffected': 391, 'seriousNumAtRisk': 417, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'All Participants', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.', 'otherNumAtRisk': 625, 'deathsNumAtRisk': 625, 'otherNumAffected': 524, 'seriousNumAtRisk': 625, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 760, 'numAffected': 177}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 561, 'numAffected': 176}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 141, 'numAffected': 67}, {'groupId': 'EG003', 'numAtRisk': 417, 'numEvents': 1385, 'numAffected': 384}, {'groupId': 'EG004', 'numAtRisk': 625, 'numEvents': 1526, 'numAffected': 451}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 93, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 77, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 78, 'numAffected': 59}, {'groupId': 'EG003', 'numAtRisk': 417, 'numEvents': 186, 'numAffected': 129}, {'groupId': 'EG004', 'numAtRisk': 625, 'numEvents': 264, 'numAffected': 188}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 118, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 86, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 417, 'numEvents': 215, 'numAffected': 147}, {'groupId': 'EG004', 'numAtRisk': 625, 'numEvents': 238, 'numAffected': 165}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 89, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 67, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 417, 'numEvents': 162, 'numAffected': 125}, {'groupId': 'EG004', 'numAtRisk': 625, 'numEvents': 176, 'numAffected': 138}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 86, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 61, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 417, 'numEvents': 158, 'numAffected': 113}, {'groupId': 'EG004', 'numAtRisk': 625, 'numEvents': 170, 'numAffected': 123}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 158, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 122, 'numAffected': 90}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 43, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 417, 'numEvents': 300, 'numAffected': 195}, {'groupId': 'EG004', 'numAtRisk': 625, 'numEvents': 343, 'numAffected': 232}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 38, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 417, 'numEvents': 71, 'numAffected': 57}, {'groupId': 'EG004', 'numAtRisk': 625, 'numEvents': 94, 'numAffected': 75}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 106, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 98, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 83, 'numAffected': 63}, {'groupId': 'EG003', 'numAtRisk': 417, 'numEvents': 220, 'numAffected': 157}, {'groupId': 'EG004', 'numAtRisk': 625, 'numEvents': 303, 'numAffected': 220}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 417, 'numEvents': 47, 'numAffected': 40}, {'groupId': 'EG004', 'numAtRisk': 625, 'numEvents': 74, 'numAffected': 60}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 417, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 625, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Reactive attachment disorder of infancy or early childhood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 625, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 625, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 625, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 417, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 625, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 417, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 625, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 625, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '417', 'groupId': 'OG003'}, {'value': '625', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VLA15', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG001', 'title': 'Group 2: VLA15 + Placebo', 'description': 'Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG002', 'title': 'Group 3: Placebo', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG003', 'title': 'Any VLA15', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.'}, {'id': 'OG004', 'title': 'All Participants', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.'}], 'classes': [{'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '402', 'groupId': 'OG003'}, {'value': '602', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000', 'lowerLimit': '55.9', 'upperLimit': '69.7'}, {'value': '59.3', 'groupId': 'OG001', 'lowerLimit': '52.1', 'upperLimit': '66.2'}, {'value': '12.5', 'groupId': 'OG002', 'lowerLimit': '8.6', 'upperLimit': '17.8'}, {'value': '60.4', 'groupId': 'OG003', 'lowerLimit': '55.6', 'upperLimit': '65.1'}, {'value': '44.5', 'groupId': 'OG004', 'lowerLimit': '40.6', 'upperLimit': '48.5'}]}]}, {'title': 'Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '406', 'groupId': 'OG003'}, {'value': '606', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '81.6', 'groupId': 'OG000', 'lowerLimit': '75.4', 'upperLimit': '86.5'}, {'value': '84.8', 'groupId': 'OG001', 'lowerLimit': '78.9', 'upperLimit': '89.3'}, {'value': '19.5', 'groupId': 'OG002', 'lowerLimit': '14.6', 'upperLimit': '25.5'}, {'value': '81.8', 'groupId': 'OG003', 'lowerLimit': '77.7', 'upperLimit': '85.2'}, {'value': '61.2', 'groupId': 'OG004', 'lowerLimit': '57.3', 'upperLimit': '65.0'}]}]}, {'title': 'Erythema/redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}, {'value': '397', 'groupId': 'OG003'}, {'value': '596', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '17.7'}, {'value': '14.9', 'groupId': 'OG001', 'lowerLimit': '10.5', 'upperLimit': '20.8'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '5.7'}, {'value': '13.1', 'groupId': 'OG003', 'lowerLimit': '10.1', 'upperLimit': '16.8'}, {'value': '9.6', 'groupId': 'OG004', 'lowerLimit': '7.5', 'upperLimit': '12.2'}]}]}, {'title': 'Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '394', 'groupId': 'OG003'}, {'value': '594', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '14.0'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '13.9'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '2.8'}, {'value': '9.1', 'groupId': 'OG003', 'lowerLimit': '6.7', 'upperLimit': '12.4'}, {'value': '6.2', 'groupId': 'OG004', 'lowerLimit': '4.6', 'upperLimit': '8.5'}]}]}, {'title': 'Induration/Hardening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}, {'value': '395', 'groupId': 'OG003'}, {'value': '594', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '15.3'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '11.2'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '3.6'}, {'value': '8.9', 'groupId': 'OG003', 'lowerLimit': '6.4', 'upperLimit': '12.1'}, {'value': '6.2', 'groupId': 'OG004', 'lowerLimit': '4.6', 'upperLimit': '8.5'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '396', 'groupId': 'OG003'}, {'value': '596', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '24.9', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '31.6'}, {'value': '21.1', 'groupId': 'OG001', 'lowerLimit': '15.8', 'upperLimit': '27.6'}, {'value': '19.5', 'groupId': 'OG002', 'lowerLimit': '14.6', 'upperLimit': '25.5'}, {'value': '23.5', 'groupId': 'OG003', 'lowerLimit': '19.6', 'upperLimit': '27.9'}, {'value': '22.1', 'groupId': 'OG004', 'lowerLimit': '19.0', 'upperLimit': '25.7'}]}]}, {'title': 'Muscle pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '401', 'groupId': 'OG003'}, {'value': '601', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.1', 'groupId': 'OG000', 'lowerLimit': '29.5', 'upperLimit': '43.2'}, {'value': '34.6', 'groupId': 'OG001', 'lowerLimit': '28.1', 'upperLimit': '41.8'}, {'value': '11.0', 'groupId': 'OG002', 'lowerLimit': '7.4', 'upperLimit': '16.1'}, {'value': '35.7', 'groupId': 'OG003', 'lowerLimit': '31.1', 'upperLimit': '40.5'}, {'value': '27.5', 'groupId': 'OG004', 'lowerLimit': '24.0', 'upperLimit': '31.2'}]}]}, {'title': 'Joint pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '395', 'groupId': 'OG003'}, {'value': '596', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '15.2'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '7.8'}, {'value': '6.5', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '10.7'}, {'value': '7.6', 'groupId': 'OG003', 'lowerLimit': '5.4', 'upperLimit': '10.6'}, {'value': '7.2', 'groupId': 'OG004', 'lowerLimit': '5.4', 'upperLimit': '9.6'}]}]}, {'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '392', 'groupId': 'OG003'}, {'value': '592', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '7.9'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '10.6'}, {'value': '6.0', 'groupId': 'OG002', 'lowerLimit': '3.5', 'upperLimit': '10.2'}, {'value': '5.4', 'groupId': 'OG003', 'lowerLimit': '3.5', 'upperLimit': '8.1'}, {'value': '5.6', 'groupId': 'OG004', 'lowerLimit': '4.0', 'upperLimit': '7.7'}]}]}, {'title': 'Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}, {'value': '392', 'groupId': 'OG003'}, {'value': '591', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '4.0'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.1'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '3.6'}, {'value': '0.8', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '2.2'}, {'value': '0.8', 'groupId': 'OG004', 'lowerLimit': '0.4', 'upperLimit': '2.0'}]}]}, {'title': 'Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '395', 'groupId': 'OG003'}, {'value': '596', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000', 'lowerLimit': '15.4', 'upperLimit': '27.2'}, {'value': '17.1', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '23.3'}, {'value': '16.4', 'groupId': 'OG002', 'lowerLimit': '11.9', 'upperLimit': '22.2'}, {'value': '19.7', 'groupId': 'OG003', 'lowerLimit': '16.1', 'upperLimit': '24.0'}, {'value': '18.6', 'groupId': 'OG004', 'lowerLimit': '15.7', 'upperLimit': '21.9'}]}]}, {'title': 'Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}, {'value': '363', 'groupId': 'OG003'}, {'value': '551', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '5.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '3.0'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '2.8'}, {'value': '0.9', 'groupId': 'OG004', 'lowerLimit': '0.4', 'upperLimit': '2.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 7 after vaccination 1 at Month 0', 'description': 'Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received. All participants reported under \'Overall Number of Participants Analyzed\' contributed data to the table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}, {'value': '399', 'groupId': 'OG003'}, {'value': '602', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VLA15', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG001', 'title': 'Group 2: VLA15 + Placebo', 'description': 'Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG002', 'title': 'Group 3: Placebo', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG003', 'title': 'Any VLA15', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.'}, {'id': 'OG004', 'title': 'All Participants', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.'}], 'classes': [{'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '390', 'groupId': 'OG003'}, {'value': '581', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '56.8', 'groupId': 'OG000', 'lowerLimit': '49.6', 'upperLimit': '63.7'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '12.8'}, {'value': '8.4', 'groupId': 'OG002', 'lowerLimit': '5.2', 'upperLimit': '13.2'}, {'value': '32.1', 'groupId': 'OG003', 'lowerLimit': '27.6', 'upperLimit': '36.8'}, {'value': '24.3', 'groupId': 'OG004', 'lowerLimit': '21.0', 'upperLimit': '27.9'}]}]}, {'title': 'Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}, {'value': '393', 'groupId': 'OG003'}, {'value': '586', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000', 'lowerLimit': '75.2', 'upperLimit': '86.3'}, {'value': '14.7', 'groupId': 'OG001', 'lowerLimit': '10.2', 'upperLimit': '20.7'}, {'value': '14.5', 'groupId': 'OG002', 'lowerLimit': '10.2', 'upperLimit': '20.2'}, {'value': '47.6', 'groupId': 'OG003', 'lowerLimit': '42.7', 'upperLimit': '52.5'}, {'value': '36.7', 'groupId': 'OG004', 'lowerLimit': '32.9', 'upperLimit': '40.7'}]}]}, {'title': 'Erythema/redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '388', 'groupId': 'OG003'}, {'value': '579', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '11.2', 'upperLimit': '21.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.1'}, {'value': '1.6', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '4.5'}, {'value': '7.5', 'groupId': 'OG003', 'lowerLimit': '5.3', 'upperLimit': '10.5'}, {'value': '5.5', 'groupId': 'OG004', 'lowerLimit': '3.9', 'upperLimit': '7.7'}]}]}, {'title': 'Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '387', 'groupId': 'OG003'}, {'value': '578', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '16.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.1'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '2.9'}, {'value': '5.4', 'groupId': 'OG003', 'lowerLimit': '3.6', 'upperLimit': '8.2'}, {'value': '3.8', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '5.7'}]}]}, {'title': 'Induration/Hardening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '390', 'groupId': 'OG003'}, {'value': '581', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '14.2'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '4.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '2.0'}, {'value': '5.4', 'groupId': 'OG003', 'lowerLimit': '3.5', 'upperLimit': '8.1'}, {'value': '3.6', 'groupId': 'OG004', 'lowerLimit': '2.4', 'upperLimit': '5.5'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}, {'value': '386', 'groupId': 'OG003'}, {'value': '578', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '22.9'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '8.4', 'upperLimit': '18.2'}, {'value': '13.0', 'groupId': 'OG002', 'lowerLimit': '9.0', 'upperLimit': '18.5'}, {'value': '15.3', 'groupId': 'OG003', 'lowerLimit': '12.0', 'upperLimit': '19.2'}, {'value': '14.5', 'groupId': 'OG004', 'lowerLimit': '11.9', 'upperLimit': '17.6'}]}]}, {'title': 'Muscle pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '388', 'groupId': 'OG003'}, {'value': '579', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000', 'lowerLimit': '18.2', 'upperLimit': '30.4'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '8.0'}, {'value': '3.7', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '7.4'}, {'value': '14.2', 'groupId': 'OG003', 'lowerLimit': '11.1', 'upperLimit': '18.0'}, {'value': '10.7', 'groupId': 'OG004', 'lowerLimit': '8.4', 'upperLimit': '13.5'}]}]}, {'title': 'Joint pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '386', 'groupId': 'OG003'}, {'value': '577', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '9.0'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '7.2'}, {'value': '1.6', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '4.5'}, {'value': '4.7', 'groupId': 'OG003', 'lowerLimit': '3.0', 'upperLimit': '7.3'}, {'value': '3.6', 'groupId': 'OG004', 'lowerLimit': '2.4', 'upperLimit': '5.5'}]}]}, {'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}, {'value': '385', 'groupId': 'OG003'}, {'value': '578', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '8.3'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '7.2'}, {'value': '5.7', 'groupId': 'OG002', 'lowerLimit': '3.2', 'upperLimit': '9.9'}, {'value': '3.6', 'groupId': 'OG003', 'lowerLimit': '2.2', 'upperLimit': '6.0'}, {'value': '4.3', 'groupId': 'OG004', 'lowerLimit': '2.9', 'upperLimit': '6.3'}]}]}, {'title': 'Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '385', 'groupId': 'OG003'}, {'value': '576', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '3.9'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '4.9'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '2.0'}, {'value': '1.3', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '3.0'}, {'value': '0.9', 'groupId': 'OG004', 'lowerLimit': '0.4', 'upperLimit': '2.0'}]}]}, {'title': 'Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}, {'value': '385', 'groupId': 'OG003'}, {'value': '577', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '19.3'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '14.3'}, {'value': '12.0', 'groupId': 'OG002', 'lowerLimit': '8.1', 'upperLimit': '17.3'}, {'value': '11.9', 'groupId': 'OG003', 'lowerLimit': '9.1', 'upperLimit': '15.6'}, {'value': '12.0', 'groupId': 'OG004', 'lowerLimit': '9.6', 'upperLimit': '14.9'}]}]}, {'title': 'Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}, {'value': '368', 'groupId': 'OG003'}, {'value': '550', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '4.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '2.1'}, {'value': '0.8', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '2.4'}, {'value': '0.5', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '1.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 7 after vaccination 2 at Month 2', 'description': 'Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received. All participants reported under \'Overall Number of Participants Analyzed\' contributed data to the table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '384', 'groupId': 'OG003'}, {'value': '575', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VLA15', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG001', 'title': 'Group 2: VLA15 + Placebo', 'description': 'Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG002', 'title': 'Group 3: Placebo', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG003', 'title': 'Any VLA15', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.'}, {'id': 'OG004', 'title': 'All Participants', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.'}], 'classes': [{'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '363', 'groupId': 'OG003'}, {'value': '542', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '57.3', 'groupId': 'OG000', 'lowerLimit': '50.0', 'upperLimit': '64.3'}, {'value': '62.4', 'groupId': 'OG001', 'lowerLimit': '55.1', 'upperLimit': '69.1'}, {'value': '5.6', 'groupId': 'OG002', 'lowerLimit': '3.1', 'upperLimit': '10.0'}, {'value': '59.5', 'groupId': 'OG003', 'lowerLimit': '54.4', 'upperLimit': '64.4'}, {'value': '41.7', 'groupId': 'OG004', 'lowerLimit': '37.6', 'upperLimit': '45.9'}]}]}, {'title': 'Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '365', 'groupId': 'OG003'}, {'value': '544', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '74.3', 'groupId': 'OG000', 'lowerLimit': '67.4', 'upperLimit': '80.1'}, {'value': '83.2', 'groupId': 'OG001', 'lowerLimit': '77.1', 'upperLimit': '88.0'}, {'value': '12.8', 'groupId': 'OG002', 'lowerLimit': '8.7', 'upperLimit': '18.5'}, {'value': '78.6', 'groupId': 'OG003', 'lowerLimit': '74.1', 'upperLimit': '82.5'}, {'value': '57.0', 'groupId': 'OG004', 'lowerLimit': '52.8', 'upperLimit': '61.1'}]}]}, {'title': 'Erythema/redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '362', 'groupId': 'OG003'}, {'value': '541', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '16.1'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '12.8'}, {'value': '1.1', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '4.0'}, {'value': '9.7', 'groupId': 'OG003', 'lowerLimit': '7.0', 'upperLimit': '13.1'}, {'value': '6.8', 'groupId': 'OG004', 'lowerLimit': '5.0', 'upperLimit': '9.3'}]}]}, {'title': 'Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '361', 'groupId': 'OG003'}, {'value': '540', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '12.8'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '15.5'}, {'value': '0.6', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '3.1'}, {'value': '9.1', 'groupId': 'OG003', 'lowerLimit': '6.6', 'upperLimit': '12.6'}, {'value': '6.3', 'groupId': 'OG004', 'lowerLimit': '4.5', 'upperLimit': '8.7'}]}]}, {'title': 'Induration/Hardening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '362', 'groupId': 'OG003'}, {'value': '541', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '12.8'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '14.1'}, {'value': '0.6', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '3.1'}, {'value': '8.3', 'groupId': 'OG003', 'lowerLimit': '5.9', 'upperLimit': '11.6'}, {'value': '5.7', 'groupId': 'OG004', 'lowerLimit': '4.1', 'upperLimit': '8.0'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '360', 'groupId': 'OG003'}, {'value': '540', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '22.8'}, {'value': '20.8', 'groupId': 'OG001', 'lowerLimit': '15.5', 'upperLimit': '27.3'}, {'value': '8.9', 'groupId': 'OG002', 'lowerLimit': '5.5', 'upperLimit': '14.0'}, {'value': '18.6', 'groupId': 'OG003', 'lowerLimit': '14.9', 'upperLimit': '23.0'}, {'value': '15.4', 'groupId': 'OG004', 'lowerLimit': '12.6', 'upperLimit': '18.7'}]}]}, {'title': 'Muscle pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '362', 'groupId': 'OG003'}, {'value': '541', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000', 'lowerLimit': '20.7', 'upperLimit': '33.7'}, {'value': '29.6', 'groupId': 'OG001', 'lowerLimit': '23.4', 'upperLimit': '36.7'}, {'value': '7.8', 'groupId': 'OG002', 'lowerLimit': '4.7', 'upperLimit': '12.7'}, {'value': '28.2', 'groupId': 'OG003', 'lowerLimit': '23.8', 'upperLimit': '33.0'}, {'value': '21.4', 'groupId': 'OG004', 'lowerLimit': '18.2', 'upperLimit': '25.1'}]}]}, {'title': 'Joint pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '360', 'groupId': 'OG003'}, {'value': '540', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '10.9'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '7.9'}, {'value': '3.3', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '7.1'}, {'value': '5.0', 'groupId': 'OG003', 'lowerLimit': '3.2', 'upperLimit': '7.8'}, {'value': '4.4', 'groupId': 'OG004', 'lowerLimit': '3.0', 'upperLimit': '6.5'}]}]}, {'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '359', 'groupId': 'OG003'}, {'value': '538', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '5.7'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '7.9'}, {'value': '2.2', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '5.6'}, {'value': '3.1', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '5.4'}, {'value': '2.8', 'groupId': 'OG004', 'lowerLimit': '1.7', 'upperLimit': '4.5'}]}]}, {'title': 'Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '359', 'groupId': 'OG003'}, {'value': '538', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '4.1'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '4.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '2.1'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '2.8'}, {'value': '0.7', 'groupId': 'OG004', 'lowerLimit': '0.3', 'upperLimit': '1.9'}]}]}, {'title': 'Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '360', 'groupId': 'OG003'}, {'value': '540', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '24.0'}, {'value': '16.9', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '23.0'}, {'value': '11.7', 'groupId': 'OG002', 'lowerLimit': '7.8', 'upperLimit': '17.2'}, {'value': '17.2', 'groupId': 'OG003', 'lowerLimit': '13.7', 'upperLimit': '21.5'}, {'value': '15.4', 'groupId': 'OG004', 'lowerLimit': '12.6', 'upperLimit': '18.7'}]}]}, {'title': 'Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}, {'value': '346', 'groupId': 'OG003'}, {'value': '519', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.2'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '5.1'}, {'value': '0.6', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '3.2'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '2.5'}, {'value': '0.8', 'groupId': 'OG004', 'lowerLimit': '0.3', 'upperLimit': '2.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 7 after vaccination 3 at Month 6', 'description': 'Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received. All participants reported under \'Overall Number of Participants Analyzed\' contributed data to the table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '417', 'groupId': 'OG003'}, {'value': '625', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VLA15', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG001', 'title': 'Group 2: VLA15 + Placebo', 'description': 'Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG002', 'title': 'Group 3: Placebo', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG003', 'title': 'Any VLA15', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.'}, {'id': 'OG004', 'title': 'All Participants', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '80.5', 'groupId': 'OG000', 'lowerLimit': '74.3', 'upperLimit': '85.5'}, {'value': '77.0', 'groupId': 'OG001', 'lowerLimit': '70.5', 'upperLimit': '82.5'}, {'value': '16.8', 'groupId': 'OG002', 'lowerLimit': '12.4', 'upperLimit': '22.5'}, {'value': '77.0', 'groupId': 'OG003', 'lowerLimit': '72.7', 'upperLimit': '80.8'}, {'value': '57.0', 'groupId': 'OG004', 'lowerLimit': '53.0', 'upperLimit': '60.8'}]}]}, {'title': 'Tenderness', 'categories': [{'measurements': [{'value': '92.6', 'groupId': 'OG000', 'lowerLimit': '88.0', 'upperLimit': '95.6'}, {'value': '92.5', 'groupId': 'OG001', 'lowerLimit': '87.8', 'upperLimit': '95.5'}, {'value': '28.4', 'groupId': 'OG002', 'lowerLimit': '22.7', 'upperLimit': '34.8'}, {'value': '90.6', 'groupId': 'OG003', 'lowerLimit': '87.5', 'upperLimit': '93.1'}, {'value': '69.9', 'groupId': 'OG004', 'lowerLimit': '66.2', 'upperLimit': '73.4'}]}]}, {'title': 'Erythema/Redness', 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000', 'lowerLimit': '21.0', 'upperLimit': '33.6'}, {'value': '18.7', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': '24.9'}, {'value': '3.4', 'groupId': 'OG002', 'lowerLimit': '1.6', 'upperLimit': '6.8'}, {'value': '21.8', 'groupId': 'OG003', 'lowerLimit': '18.1', 'upperLimit': '26.0'}, {'value': '15.7', 'groupId': 'OG004', 'lowerLimit': '13.0', 'upperLimit': '18.7'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '15.4', 'upperLimit': '26.8'}, {'value': '16.6', 'groupId': 'OG001', 'lowerLimit': '11.9', 'upperLimit': '22.6'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '4.2'}, {'value': '18.0', 'groupId': 'OG003', 'lowerLimit': '14.6', 'upperLimit': '22.0'}, {'value': '12.5', 'groupId': 'OG004', 'lowerLimit': '10.1', 'upperLimit': '15.3'}]}]}, {'title': 'Induration/Hardening', 'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '14.5', 'upperLimit': '25.7'}, {'value': '14.4', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '20.2'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '4.2'}, {'value': '16.5', 'groupId': 'OG003', 'lowerLimit': '13.3', 'upperLimit': '20.4'}, {'value': '11.5', 'groupId': 'OG004', 'lowerLimit': '9.2', 'upperLimit': '14.3'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '38.4', 'groupId': 'OG000', 'lowerLimit': '31.8', 'upperLimit': '45.5'}, {'value': '36.4', 'groupId': 'OG001', 'lowerLimit': '29.8', 'upperLimit': '43.5'}, {'value': '28.8', 'groupId': 'OG002', 'lowerLimit': '23.1', 'upperLimit': '35.3'}, {'value': '37.4', 'groupId': 'OG003', 'lowerLimit': '32.9', 'upperLimit': '42.1'}, {'value': '34.6', 'groupId': 'OG004', 'lowerLimit': '30.9', 'upperLimit': '38.4'}]}]}, {'title': 'Muscle pain', 'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000', 'lowerLimit': '38.9', 'upperLimit': '52.9'}, {'value': '48.1', 'groupId': 'OG001', 'lowerLimit': '41.1', 'upperLimit': '55.3'}, {'value': '17.8', 'groupId': 'OG002', 'lowerLimit': '13.2', 'upperLimit': '23.6'}, {'value': '46.8', 'groupId': 'OG003', 'lowerLimit': '42.0', 'upperLimit': '51.6'}, {'value': '37.1', 'groupId': 'OG004', 'lowerLimit': '33.4', 'upperLimit': '41.0'}]}]}, {'title': 'Joint pain', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '21.1'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '14.7'}, {'value': '8.2', 'groupId': 'OG002', 'lowerLimit': '5.2', 'upperLimit': '12.7'}, {'value': '13.2', 'groupId': 'OG003', 'lowerLimit': '10.3', 'upperLimit': '16.8'}, {'value': '11.5', 'groupId': 'OG004', 'lowerLimit': '9.2', 'upperLimit': '14.3'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '13.2'}, {'value': '11.2', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '16.6'}, {'value': '9.6', 'groupId': 'OG002', 'lowerLimit': '6.3', 'upperLimit': '14.4'}, {'value': '9.6', 'groupId': 'OG003', 'lowerLimit': '7.1', 'upperLimit': '12.8'}, {'value': '9.6', 'groupId': 'OG004', 'lowerLimit': '7.5', 'upperLimit': '12.2'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '6.7'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '6.8'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '3.4'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '5.0'}, {'value': '2.2', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '3.7'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '33.2', 'groupId': 'OG000', 'lowerLimit': '26.9', 'upperLimit': '40.1'}, {'value': '29.9', 'groupId': 'OG001', 'lowerLimit': '23.8', 'upperLimit': '36.9'}, {'value': '28.4', 'groupId': 'OG002', 'lowerLimit': '22.7', 'upperLimit': '34.8'}, {'value': '31.4', 'groupId': 'OG003', 'lowerLimit': '27.1', 'upperLimit': '36.0'}, {'value': '30.4', 'groupId': 'OG004', 'lowerLimit': '26.9', 'upperLimit': '34.1'}]}]}, {'title': 'Fever', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '6.7'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '4.6'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '3.4'}, {'value': '2.4', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '4.4'}, {'value': '1.9', 'groupId': 'OG004', 'lowerLimit': '1.1', 'upperLimit': '3.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 7 after vaccination 1, 2 or 3 at Month 0, 2 and 6 respectively', 'description': 'Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table and for each specified row."}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VLA15', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG001', 'title': 'Group 2: VLA15 + Placebo', 'description': 'Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG002', 'title': 'Group 3: Placebo', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.'}], 'classes': [{'title': 'ST1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '333.2', 'groupId': 'OG000', 'lowerLimit': '275.2', 'upperLimit': '403.4'}, {'value': '197.3', 'groupId': 'OG001', 'lowerLimit': '156.2', 'upperLimit': '249.3'}, {'value': '23.8', 'groupId': 'OG002', 'lowerLimit': '21.6', 'upperLimit': '26.2'}]}]}, {'title': 'ST2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '656.0', 'groupId': 'OG000', 'lowerLimit': '560.2', 'upperLimit': '768.2'}, {'value': '460.3', 'groupId': 'OG001', 'lowerLimit': '370.6', 'upperLimit': '571.8'}, {'value': '21.9', 'groupId': 'OG002', 'lowerLimit': '20.2', 'upperLimit': '23.7'}]}]}, {'title': 'ST3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '586.4', 'groupId': 'OG000', 'lowerLimit': '497.4', 'upperLimit': '691.4'}, {'value': '436.2', 'groupId': 'OG001', 'lowerLimit': '344.8', 'upperLimit': '551.8'}, {'value': '21.9', 'groupId': 'OG002', 'lowerLimit': '20.2', 'upperLimit': '23.8'}]}]}, {'title': 'ST4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '422.8', 'groupId': 'OG000', 'lowerLimit': '355.3', 'upperLimit': '503.1'}, {'value': '245.8', 'groupId': 'OG001', 'lowerLimit': '196.1', 'upperLimit': '308.2'}, {'value': '23.5', 'groupId': 'OG002', 'lowerLimit': '21.3', 'upperLimit': '25.8'}]}]}, {'title': 'ST5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '443.4', 'groupId': 'OG000', 'lowerLimit': '375.5', 'upperLimit': '523.6'}, {'value': '239.4', 'groupId': 'OG001', 'lowerLimit': '190.5', 'upperLimit': '301.0'}, {'value': '22.4', 'groupId': 'OG002', 'lowerLimit': '20.6', 'upperLimit': '24.4'}]}]}, {'title': 'ST6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '429.7', 'groupId': 'OG000', 'lowerLimit': '360.2', 'upperLimit': '512.8'}, {'value': '222.0', 'groupId': 'OG001', 'lowerLimit': '177.4', 'upperLimit': '277.8'}, {'value': '24.3', 'groupId': 'OG002', 'lowerLimit': '22.1', 'upperLimit': '26.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 208 (Month 7)', 'description': 'GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay at Day 208 is presented in this outcome measure.', 'unitOfMeasure': 'Units per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Analysis Set (PPAS) consisted of the FAS population excluding those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). All participants reported under \'Overall Number of Participants Analyzed\' contributed data to the table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants with available results for each serotype.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Dose', 'timeFrame': 'Within 7 days after booster dose', 'description': 'Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '417', 'groupId': 'OG003'}, {'value': '625', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VLA15', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG001', 'title': 'Group 2: VLA15 + Placebo', 'description': 'Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG002', 'title': 'Group 3: Placebo', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG003', 'title': 'Any VLA15', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.'}, {'id': 'OG004', 'title': 'All Participants', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.0'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '3.8'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '4.8'}, {'value': '0.7', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '2.1'}, {'value': '1.1', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '2.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 of vaccination up to Day 208 (Month 7)', 'description': 'SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. Two-sided 95% confidence intervals were calculated according to Altman method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events of Special Interest (AESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '417', 'groupId': 'OG003'}, {'value': '625', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VLA15', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG001', 'title': 'Group 2: VLA15 + Placebo', 'description': 'Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG002', 'title': 'Group 3: Placebo', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG003', 'title': 'Any VLA15', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.'}, {'id': 'OG004', 'title': 'All Participants', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.0'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '1.2', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '2.8'}, {'value': '0.8', 'groupId': 'OG004', 'lowerLimit': '0.3', 'upperLimit': '1.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 of vaccination up to Day 208 (Month 7)', 'description': "An AESI (serious or non-serious) was one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor were appropriate. Two-sided 95% confidence intervals were calculated according to Altman method.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Unsolicited Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '417', 'groupId': 'OG003'}, {'value': '625', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VLA15', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG001', 'title': 'Group 2: VLA15 + Placebo', 'description': 'Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG002', 'title': 'Group 3: Placebo', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG003', 'title': 'Any VLA15', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.'}, {'id': 'OG004', 'title': 'All Participants', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000', 'lowerLimit': '12.2', 'upperLimit': '22.8'}, {'value': '25.1', 'groupId': 'OG001', 'lowerLimit': '19.5', 'upperLimit': '31.8'}, {'value': '24.5', 'groupId': 'OG002', 'lowerLimit': '19.2', 'upperLimit': '30.8'}, {'value': '20.9', 'groupId': 'OG003', 'lowerLimit': '17.2', 'upperLimit': '25.0'}, {'value': '22.1', 'groupId': 'OG004', 'lowerLimit': '19.0', 'upperLimit': '25.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 28 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively', 'description': 'An AE was any untoward medical occurrence in a participant administered an investigational product, whether or not related to this treatment. Unsolicited AEs were defined as any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event. Two-sided 95% confidence intervals were calculated according to Altman method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '417', 'groupId': 'OG003'}, {'value': '625', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: VLA15', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG001', 'title': 'Group 2: VLA15 + Placebo', 'description': 'Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG002', 'title': 'Group 3: Placebo', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'OG003', 'title': 'Any VLA15', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.'}, {'id': 'OG004', 'title': 'All Participants', 'description': 'Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.'}], 'classes': [{'title': 'SAE: 18 to 65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '213', 'groupId': 'OG003'}, {'value': '320', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.8'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '6.0'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '6.6'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '2.6'}, {'value': '0.9', 'groupId': 'OG004', 'lowerLimit': '0.3', 'upperLimit': '2.7'}]}]}, {'title': 'SAE: 12 to 17 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.4'}, {'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '13.5'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '5.4'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '0.7', 'upperLimit': '5.7'}]}]}, {'title': 'SAE: 5 to 11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '155', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.3'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '10.7'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '5.2'}, {'value': '0.6', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '3.6'}]}]}, {'title': 'AESI: 18 to 65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '213', 'groupId': 'OG003'}, {'value': '320', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.5'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '3.4'}, {'value': '0.6', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '2.2'}]}]}, {'title': 'AESI: 12 to 17 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.1'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '5.4'}, {'value': '0.7', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '3.7'}]}]}, {'title': 'AESI: 5 to 11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '155', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.3'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '10.7'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '1.9', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '6.7'}, {'value': '1.3', 'groupId': 'OG004', 'lowerLimit': '0.4', 'upperLimit': '4.6'}]}]}, {'title': 'Solicited AE: 18 to 65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '213', 'groupId': 'OG003'}, {'value': '320', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG000', 'lowerLimit': '88.5', 'upperLimit': '97.8'}, {'value': '95.6', 'groupId': 'OG001', 'lowerLimit': '89.1', 'upperLimit': '98.3'}, {'value': '62.6', 'groupId': 'OG002', 'lowerLimit': '53.2', 'upperLimit': '71.2'}, {'value': '93.9', 'groupId': 'OG003', 'lowerLimit': '89.8', 'upperLimit': '96.4'}, {'value': '83.4', 'groupId': 'OG004', 'lowerLimit': '79.0', 'upperLimit': '87.1'}]}]}, {'title': 'Solicited AE: 12 to 17 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '88.2', 'upperLimit': '99.6'}, {'value': '93.8', 'groupId': 'OG001', 'lowerLimit': '83.2', 'upperLimit': '97.9'}, {'value': '60.0', 'groupId': 'OG002', 'lowerLimit': '46.2', 'upperLimit': '72.4'}, {'value': '95.0', 'groupId': 'OG003', 'lowerLimit': '88.8', 'upperLimit': '97.8'}, {'value': '83.3', 'groupId': 'OG004', 'lowerLimit': '76.6', 'upperLimit': '88.4'}]}]}, {'title': 'Solicited AE: 5 to 11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '155', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000', 'lowerLimit': '75.8', 'upperLimit': '94.3'}, {'value': '98.0', 'groupId': 'OG001', 'lowerLimit': '89.3', 'upperLimit': '99.6'}, {'value': '64.7', 'groupId': 'OG002', 'lowerLimit': '51.0', 'upperLimit': '76.4'}, {'value': '93.3', 'groupId': 'OG003', 'lowerLimit': '86.8', 'upperLimit': '96.7'}, {'value': '83.9', 'groupId': 'OG004', 'lowerLimit': '77.3', 'upperLimit': '88.8'}]}]}, {'title': 'Unsolicited AE: 18 to 65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '213', 'groupId': 'OG003'}, {'value': '320', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '33.1'}, {'value': '30.0', 'groupId': 'OG001', 'lowerLimit': '21.5', 'upperLimit': '40.1'}, {'value': '29.0', 'groupId': 'OG002', 'lowerLimit': '21.2', 'upperLimit': '38.2'}, {'value': '26.3', 'groupId': 'OG003', 'lowerLimit': '20.8', 'upperLimit': '32.6'}, {'value': '27.2', 'groupId': 'OG004', 'lowerLimit': '22.6', 'upperLimit': '32.3'}]}]}, {'title': 'Unsolicited AE: 12 to 17 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '32.0'}, {'value': '20.8', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '34.3'}, {'value': '22.0', 'groupId': 'OG002', 'lowerLimit': '12.8', 'upperLimit': '35.2'}, {'value': '19.0', 'groupId': 'OG003', 'lowerLimit': '12.5', 'upperLimit': '27.8'}, {'value': '20.0', 'groupId': 'OG004', 'lowerLimit': '14.4', 'upperLimit': '27.1'}]}]}, {'title': 'Unsolicited AE: 5 to 11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '155', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '10.7'}, {'value': '20.4', 'groupId': 'OG001', 'lowerLimit': '11.5', 'upperLimit': '33.6'}, {'value': '17.6', 'groupId': 'OG002', 'lowerLimit': '9.6', 'upperLimit': '30.3'}, {'value': '11.5', 'groupId': 'OG003', 'lowerLimit': '6.7', 'upperLimit': '19.1'}, {'value': '13.5', 'groupId': 'OG004', 'lowerLimit': '9.0', 'upperLimit': '19.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'SAEs, AESIs: From Day 1 of vaccination (vac) up to Day 208 (Month 7), Solicited AEs: From Day 1 to Day 7 after vac 1, 2 and 3 at Month 0, 2 and 6, respectively; Unsolicited AEs: From Day 1 to Day 28 after vac 1, 2 and 3 at Month 0, 2 and 6, respectively', 'description': "Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs stratified by age group 18 to 65, 12 to 17 and 5 to 11 years were reported. SAE: any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. AESI: scientific and medical concern specific to the sponsor's product or program. Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AEs: any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event. Unsolicited AEs were collected only up to 28 days after any vaccination. Two-sided 95% confidence intervals were calculated according to Altman method.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. All participants reported under \'Overall Number of Participants Analyzed\' contributed data to the table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Baseline, Day 85, Day 180 and Day 194 During the Main Study Phase', 'timeFrame': 'Baseline, Day 85, Day 180 and Day 194', 'description': 'GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'SECONDARY', 'title': 'Seroconversion Rate for Each OspA Serotype (ST1 to ST6) Specific IgG at Day 85, 180, 194 and 208', 'timeFrame': 'Day 85, Day 180, Day 194 and Day 208', 'description': 'Seroconversion Rate (SCR) for each OspA serotype specific IgG ST1 to ST6, determined by enzyme linked immunosorbent assay (ELISA). Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of \\>=40 Units per milliliter \\[U/mL\\]) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a \\>= 4-fold rise in OspA IgG antibody titer from screening.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'SECONDARY', 'title': 'Geometric Mean of the Fold Rise (GMFR) for IgG Against Each OspA Serotype (ST1 to ST6) at Day 85 and Day 208 During the Main Study Phase', 'timeFrame': 'Baseline, Day 85 and 208', 'description': 'GMFR as compared to baseline for IgG against each OspA serotype ST1 to ST6, determined by IgG binding assay at Day 85 and Day 208.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'SECONDARY', 'title': 'GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Baseline, Day 85, Day 180, Day 194 and Day 208 During the Main Study Phase', 'timeFrame': 'Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208', 'description': 'GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (18 to 65, 12 to 17 and 5 to 11 years).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'SECONDARY', 'title': 'Seroconversion Rate for Each OspA Serotype (ST1 to ST6) Specific IgG at Day 85, 180, 194 and 208 Stratified by Age Group During the Main Study Phase', 'timeFrame': 'Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208', 'description': 'SCR for each OspA serotype specific IgG ST1 to ST6, determined by ELISA stratified by age group (18 to 65, 12 to 17 and 5 to 11 years). Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of \\>=40 Units per milliliter \\[U/mL\\]) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a \\>= 4-fold rise in OspA IgG antibody titer from screening.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'SECONDARY', 'title': 'Geometric Mean of the Fold Rise (GMFR) for IgG Against Each OspA Serotype (ST1 to ST6) at Day 85, Day 180, Day 194 and Day 208 Stratified by Age Group During the Main Study Phase', 'timeFrame': 'Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208', 'description': 'GMFR as compared to baseline for IgG against each OspA serotype ST1 to ST6, stratified by age group (18 to 65, 12 to 17 and 5 to 11 years) determined by IgG binding assay at Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'SECONDARY', 'title': 'GMTs for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase', 'timeFrame': 'Up to Month 48', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'SECONDARY', 'title': 'SCR for Each OspA Serotype (ST1 to ST6) IgG During the Booster Phase', 'timeFrame': 'Up to Month 48', 'description': 'Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: a change from seronegative at screening to seropositive (i.e. antibody titer of \\>=40 U/mL) at a certain time point. 2) For participants who were seropositive at screening: a \\>= 4-fold rise in OspA IgG antibody titer from screening.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'SECONDARY', 'title': 'GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Month 19 During the Booster Phase', 'timeFrame': 'Month 19', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'SECONDARY', 'title': 'GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase', 'timeFrame': 'Up to Month 48', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'SECONDARY', 'title': 'SCR for Each OspA Serotype (ST1 to ST6) IgG Stratified by Age Cohort During the Booster Phase', 'timeFrame': 'Up to Month 48', 'description': 'Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: a change from seronegative at screening to seropositive (i.e. antibody titer of \\>=40 U/mL) at a certain time point. 2) For participants who were seropositive at screening: a \\>= 4-fold rise in OspA IgG antibody titer from screening.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'SECONDARY', 'title': 'GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase', 'timeFrame': 'Up to Month 48', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: VLA15', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'FG001', 'title': 'Group 2: VLA15 + Placebo', 'description': 'Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'FG002', 'title': 'Group 3: Placebo', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '209'}, {'groupId': 'FG002', 'numSubjects': '208'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '209'}, {'groupId': 'FG002', 'numSubjects': '208'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Individual stopping criteria reached', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Ongoing in the study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '195'}, {'groupId': 'FG001', 'numSubjects': '195'}, {'groupId': 'FG002', 'numSubjects': '192'}]}]}], 'preAssignmentDetails': 'A total of 714 participants were screened of which 89 failed screening and 625 participants were randomized into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}, {'value': '625', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: VLA15', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'BG001', 'title': 'Group 2: VLA15 + Placebo', 'description': 'Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'BG002', 'title': 'Group 3: Placebo', 'description': 'Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'spread': '19.08', 'groupId': 'BG000'}, {'value': '28.9', 'spread': '19.56', 'groupId': 'BG001'}, {'value': '29.0', 'spread': '19.72', 'groupId': 'BG002'}, {'value': '28.9', 'spread': '19.42', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '321', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '304', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}, {'value': '532', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set included all participants enrolled who received at least one vaccination. Participants were analyzed according to the study group they were allocated to, rather than by the actual treatment they received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-31', 'size': 1696738, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-31T11:26', 'hasProtocol': True}, {'date': '2022-03-03', 'size': 5661563, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-24T14:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 625}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2021-03-08', 'resultsFirstSubmitDate': '2023-03-24', 'studyFirstSubmitQcDate': '2021-03-15', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-05-10', 'studyFirstPostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1', 'timeFrame': 'From Day 1 to Day 7 after vaccination 1 at Month 0', 'description': 'Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.'}, {'measure': 'Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2', 'timeFrame': 'From Day 1 to Day 7 after vaccination 2 at Month 2', 'description': 'Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.'}, {'measure': 'Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3', 'timeFrame': 'From Day 1 to Day 7 after vaccination 3 at Month 6', 'description': 'Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.'}, {'measure': 'Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase', 'timeFrame': 'From Day 1 to Day 7 after vaccination 1, 2 or 3 at Month 0, 2 and 6 respectively', 'description': 'Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.'}, {'measure': 'Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase', 'timeFrame': 'Day 208 (Month 7)', 'description': 'GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay at Day 208 is presented in this outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Dose', 'timeFrame': 'Within 7 days after booster dose', 'description': 'Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.'}, {'measure': 'Percentage of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'From Day 1 of vaccination up to Day 208 (Month 7)', 'description': 'SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. Two-sided 95% confidence intervals were calculated according to Altman method.'}, {'measure': 'Percentage of Participants With Adverse Events of Special Interest (AESIs)', 'timeFrame': 'From Day 1 of vaccination up to Day 208 (Month 7)', 'description': "An AESI (serious or non-serious) was one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor were appropriate. Two-sided 95% confidence intervals were calculated according to Altman method."}, {'measure': 'Percentage of Participants With Unsolicited Adverse Events', 'timeFrame': 'From Day 1 to Day 28 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively', 'description': 'An AE was any untoward medical occurrence in a participant administered an investigational product, whether or not related to this treatment. Unsolicited AEs were defined as any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event. Two-sided 95% confidence intervals were calculated according to Altman method.'}, {'measure': 'Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group', 'timeFrame': 'SAEs, AESIs: From Day 1 of vaccination (vac) up to Day 208 (Month 7), Solicited AEs: From Day 1 to Day 7 after vac 1, 2 and 3 at Month 0, 2 and 6, respectively; Unsolicited AEs: From Day 1 to Day 28 after vac 1, 2 and 3 at Month 0, 2 and 6, respectively', 'description': "Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs stratified by age group 18 to 65, 12 to 17 and 5 to 11 years were reported. SAE: any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. AESI: scientific and medical concern specific to the sponsor's product or program. Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AEs: any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event. Unsolicited AEs were collected only up to 28 days after any vaccination. Two-sided 95% confidence intervals were calculated according to Altman method."}, {'measure': 'GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Baseline, Day 85, Day 180 and Day 194 During the Main Study Phase', 'timeFrame': 'Baseline, Day 85, Day 180 and Day 194', 'description': 'GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay.'}, {'measure': 'Seroconversion Rate for Each OspA Serotype (ST1 to ST6) Specific IgG at Day 85, 180, 194 and 208', 'timeFrame': 'Day 85, Day 180, Day 194 and Day 208', 'description': 'Seroconversion Rate (SCR) for each OspA serotype specific IgG ST1 to ST6, determined by enzyme linked immunosorbent assay (ELISA). Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of \\>=40 Units per milliliter \\[U/mL\\]) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a \\>= 4-fold rise in OspA IgG antibody titer from screening.'}, {'measure': 'Geometric Mean of the Fold Rise (GMFR) for IgG Against Each OspA Serotype (ST1 to ST6) at Day 85 and Day 208 During the Main Study Phase', 'timeFrame': 'Baseline, Day 85 and 208', 'description': 'GMFR as compared to baseline for IgG against each OspA serotype ST1 to ST6, determined by IgG binding assay at Day 85 and Day 208.'}, {'measure': 'GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Baseline, Day 85, Day 180, Day 194 and Day 208 During the Main Study Phase', 'timeFrame': 'Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208', 'description': 'GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (18 to 65, 12 to 17 and 5 to 11 years).'}, {'measure': 'Seroconversion Rate for Each OspA Serotype (ST1 to ST6) Specific IgG at Day 85, 180, 194 and 208 Stratified by Age Group During the Main Study Phase', 'timeFrame': 'Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208', 'description': 'SCR for each OspA serotype specific IgG ST1 to ST6, determined by ELISA stratified by age group (18 to 65, 12 to 17 and 5 to 11 years). Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of \\>=40 Units per milliliter \\[U/mL\\]) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a \\>= 4-fold rise in OspA IgG antibody titer from screening.'}, {'measure': 'Geometric Mean of the Fold Rise (GMFR) for IgG Against Each OspA Serotype (ST1 to ST6) at Day 85, Day 180, Day 194 and Day 208 Stratified by Age Group During the Main Study Phase', 'timeFrame': 'Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208', 'description': 'GMFR as compared to baseline for IgG against each OspA serotype ST1 to ST6, stratified by age group (18 to 65, 12 to 17 and 5 to 11 years) determined by IgG binding assay at Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208.'}, {'measure': 'GMTs for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase', 'timeFrame': 'Up to Month 48'}, {'measure': 'SCR for Each OspA Serotype (ST1 to ST6) IgG During the Booster Phase', 'timeFrame': 'Up to Month 48', 'description': 'Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: a change from seronegative at screening to seropositive (i.e. antibody titer of \\>=40 U/mL) at a certain time point. 2) For participants who were seropositive at screening: a \\>= 4-fold rise in OspA IgG antibody titer from screening.'}, {'measure': 'GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Month 19 During the Booster Phase', 'timeFrame': 'Month 19'}, {'measure': 'GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase', 'timeFrame': 'Up to Month 48'}, {'measure': 'SCR for Each OspA Serotype (ST1 to ST6) IgG Stratified by Age Cohort During the Booster Phase', 'timeFrame': 'Up to Month 48', 'description': 'Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: a change from seronegative at screening to seropositive (i.e. antibody titer of \\>=40 U/mL) at a certain time point. 2) For participants who were seropositive at screening: a \\>= 4-fold rise in OspA IgG antibody titer from screening.'}, {'measure': 'GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase', 'timeFrame': 'Up to Month 48'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VLA15', 'Lyme Borreliosis', 'Vaccine', 'Lyme disease', 'Borrelia'], 'conditions': ['Lyme Borreliosis']}, 'referencesModule': {'references': [{'pmid': '41213278', 'type': 'DERIVED', 'citation': 'Wagner L, Obersriebnig M, Hochreiter R, Kadlecek V, Larcher-Senn J, Hegele L, Maguire JD, Murphy T, Derhaschnig U, Bezay N, Jaramillo JC, Eder-Lingelbach S, Messier M. Immunogenicity and safety of an 18-month booster dose of the VLA15 Lyme borreliosis vaccine candidate after primary immunisation in children, adolescents, and adults in the USA: a randomised, observer-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2025 Nov 7:S1473-3099(25)00541-9. doi: 10.1016/S1473-3099(25)00541-9. Online ahead of print.'}, {'pmid': '40294611', 'type': 'DERIVED', 'citation': 'Wagner L, Obersriebnig M, Kadlecek V, Hochreiter R, Ghadge SK, Larcher-Senn J, Hegele L, Maguire JD, Derhaschnig U, Jaramillo JC, Eder-Lingelbach S, Bezay N. Immunogenicity and safety of different immunisation schedules of the VLA15 Lyme borreliosis vaccine candidate in adults, adolescents, and children: a randomised, observer-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2025 Sep;25(9):986-999. doi: 10.1016/S1473-3099(25)00092-1. Epub 2025 Apr 25.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=VLA15-221', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'VLA15-221 is a Phase 2 study, which will be conducted in two parts: Main Study Phase (Part A) and Booster Phase (Part B). The study will compare the safety and immunogenicity of two different primary immunization schedules applying three (Month 0-2-6) or two (Month 0- 6) vaccinations. Within the study, 600 healthy subjects aged 5-65 years will be included. Subjects with a history of Lyme borreliosis (previous infection with Borrelia) as well as Borrelia naïve subjects will be enrolled. Study duration per subject will be a maximum of 50 months per subject.', 'detailedDescription': 'VLA15-221 is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study, which is set up in two parts: Main Study Phase (Part A) and Booster Phase (Part B). In Part A 600 subjects aged 5-65 years will be enrolled 1:1:1 into three groups: Group 1 will be vaccinated with VLA15 at Month 0-2-6, Group 2 will be vaccinated with VLA15 at Month 0-6 and with placebo at Month 2 and Group 3 will be vaccinated with placebo at Month 0-2-6. In Part B all eligible subjects will receive booster injections with VLA15 or placebo at Month 18, 30 and 42.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is aged 5 to 65 years at the day of screening (Visit 0)\n* Subject is of good general health\n* Parent(s)/legal representative(s) and subject understand the study and its procedures, agree to its provisions\n\n * for subjects aged 18-65 years: written informed consent prior to any study related procedures\n * for subjects aged 5-17 years: written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable, prior to any study related procedures.\n* If subject is of childbearing potential: Subject has a negative serum pregnancy test at screening (Visit 0) and agrees to employ adequate birth control measures according to following timelines:\n\n * Main Study Phase: duration of entire study\n * Booster Phase: until 5 months after each booster vaccination (Booster 1 until Month 23, Booster 2 until Month 35 and Booster 3 until Month 47)\n* Subject is willing and able to comply with scheduled visits, treatment plan, and other study procedures\n* Subject is available for the duration of the study and can be contacted by telephone during study participation\n\nExclusion Criteria:\n\n* Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB, or received treatment for LB within the last 3 months prior to Day 1;\n* Subject received previous vaccination against LB;\n* Subject had a tick bite within 4 weeks prior to Day 1;\n* Subject has a medical history of or currently has a clinically relevant disease;\n* Subject has a medical history of or currently has a neuro- inflammatory or autoimmune disease;\n* Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the 3 weeks prior to Day 1;\n* Subject has received an active or passive immunization within 4 weeks prior to Day 1;\n* Subject has received any other registered or non-registered medicinal product in another clinical trial within 4 weeks prior to vaccination at Day 1;\n* Subject has a known or suspected defect of the immune system or received immuno-suppressive therapy within 4 weeks prior to Day 1;\n* Subject has a history of anaphylaxis of unknown cause or severe allergic reactions of unknown cause or has a known hypersensitivity or allergic reactions to one of the components of the vaccine;\n* Subject had any malignancy in the past 5 years;\n* Subject is pregnant, has plans to become pregnant during the course of the study or is lactating at the time of enrollment;\n* Subject has donated or plans to donate blood or blood-derived products 4 weeks prior to Day 1;\n* Subject has any condition that may compromise its well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study;\n* Subject is in a dependent relationship with the sponsor/investigator"}, 'identificationModule': {'nctId': 'NCT04801420', 'briefTitle': 'Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'SAFETY AND IMMUNOGENICITY STUDY OF VLA15, A MULTIVALENT RECOMBINANT OSPA BASED VACCINE CANDIDATE AGAINST LYME BORRELIOSIS: A RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE 2 STUDY IN A HEALTHY PEDIATRIC AND ADULT STUDY POPULATION', 'orgStudyIdInfo': {'id': 'VLA15-221'}, 'secondaryIdInfos': [{'id': 'C4601008', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A+B - Group 1', 'description': 'Part A: VLA15 at Month 0, 2 and 6 Part B: VLA15 at Month 18, 30 and 42', 'interventionNames': ['Biological: VLA15']}, {'type': 'EXPERIMENTAL', 'label': 'Part A+B - Group 2', 'description': 'Part A: VLA15 at Month 0 and 6, placebo at Month 2 Part B: VLA15 at Month 18, 30 and 42', 'interventionNames': ['Biological: VLA15', 'Biological: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A+B - Group 3', 'description': 'Part A: Placebo at Month 0, 2 and 6 Part B: Placebo at Month 18, 30 and 42', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'VLA15', 'type': 'BIOLOGICAL', 'description': 'a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate', 'armGroupLabels': ['Part A+B - Group 1', 'Part A+B - Group 2']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'PBS (Phosphate Buffered Saline)', 'armGroupLabels': ['Part A+B - Group 2', 'Part A+B - Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06606', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New England Research Associates', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '06905', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Stamford Therapeutics Consortium', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Chase Medical Research, LLC', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pediatric Associates of Conn. PC', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '01752', 'city': 'Marlborough', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Quest Diagnostics', 'geoPoint': {'lat': 42.34593, 'lon': -71.55229}}, {'zip': '55402', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Clinical Research Institute, Inc.', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '07018', 'city': 'East Orange', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Foundation Pediatrics', 'geoPoint': {'lat': 40.76732, 'lon': -74.20487}}, {'zip': '07111', 'city': 'Irvington', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Med Clinical Research Partners, LLC', 'geoPoint': {'lat': 40.73232, 'lon': -74.23487}}, {'zip': '13905', 'city': 'Binghamton', 'state': 'New York', 'country': 'United States', 'facility': 'Meridian Clinical Research LLC', 'geoPoint': {'lat': 42.09869, 'lon': -75.91797}}, {'zip': '10965', 'city': 'Pearl River', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Vaccine Research and Development', 'geoPoint': {'lat': 41.05899, 'lon': -74.02181}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Clinical Research, Inc.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '10314', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Richmond Behavioral Associates', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Advantage Clinical Trials', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Velocity Clinical Research, Inc.', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '16506', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny Health and Wellness Pavilion', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '16508', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Liberty Family Practice', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '19034', 'city': 'Fort Washington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lockman & Lubell Pediatric Associates', 'geoPoint': {'lat': 40.14178, 'lon': -75.20906}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': "Hasbro Children's Hospital", 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Velocity Clinical Research Providence', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '12247', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Synevo Studien Service Labor GmbH c/o Institut für Medizinische Diagnostik', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Valneva Austria GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}