Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:38 AM
Study NCT ID:
NCT05299359
Status:
COMPLETED
Last Update Posted:
2024-10-21
First Post:
2022-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Single Heterologous Booster Vaccination Study of TAK-019 in Healthy Japanese Adults (COVID-19)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TrialDisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Study Director', 'organization': 'Takeda'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Main Part: Day 1 up to 366 and Extension Part: Day 1 up to Day 366 (Participants who participated in the Main Part and the Extension Part, total participation duration was approximately 17 months)', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 milliliter (mL), intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 123, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Extension Part: TAK-019', 'description': 'Participants received a second booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension Part.', 'otherNumAtRisk': 129, 'deathsNumAtRisk': 129, 'otherNumAffected': 107, 'seriousNumAtRisk': 129, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 37}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 65}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 34}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 89}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Cerebral thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Main Part: Geometric Mean Titers (GMT) Ratio of Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Day 15 Compared With That Observed on Day 36 in Participants From the TAK-019-1501 Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: Day 15 of This Study: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}, {'id': 'OG001', 'title': 'Day 36 for TAK-019-1501 Study', 'description': 'TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm, once on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '1143.9', 'groupId': 'OG000', 'lowerLimit': '1000.5', 'upperLimit': '1307.9'}, {'value': '884.4', 'groupId': 'OG001', 'lowerLimit': '749.0', 'upperLimit': '1044.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.47', 'groupDescription': 'GMT ratio was calculated GMT of TAK-019-3001 on Day 15 divided by GMT of TAK-019-1501 study on Day 36.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'If the lower limit of the 95% CI is \\>= 0.67, then the immune response to a single heterologous booster vaccination of TAK-019 is considered to be non-inferior of that to the primary series of TAK-019.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 15 for this study (14 days after the vaccination); Day 36 for TAK-019-1501 study (14 days after the second vaccination)', 'description': 'GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values was measured as below lower limit of quantification (LLOQ) were imputed to a value that was half of the LLOQ. LLOQ was equal to 20. GMT for each group and GMT ratio of neutralizing antibody titers to the ancestral strain (wild-type virus) on Day15 after a single booster vaccination (14 days after the booster vaccination) compared with that observed on Day 36 (14 days after the second vaccination) in participants from the TAK-019-1501 study (NCT04712110) were reported. GMT ratio was calculated with GMT of TAK-019-3001 on Day 15 divided by GMT of TAK-019-1501 study on Day 36. Here, ELISA is Enzyme-linked immunosorbent assay.', 'unitOfMeasure': 'ELISA units per mL (EU/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Set: PPS was defined to include participants in the Full Analysis Set (FAS) and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. FAS was defined as all enrolled participants who received at least 1 dose of the trial vaccination.'}, {'type': 'PRIMARY', 'title': 'Main Part: Percentage of Participants With Reported Solicited Local Adverse Events (AEs) for 7 Days Following the First Single Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Main Part: 7 days after the first single booster vaccination', 'description': 'AE was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product (IMP); it did not necessarily have to have a causal relationship with IMP administration. Reported solicited local AEs were defined as injection site pain, tenderness, erythema/redness, induration, and swelling.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Main Part: The safety analysis set included all participants who received at least 1 dose of the trial vaccination.'}, {'type': 'PRIMARY', 'title': 'Main Part: Percentage of Participants With Solicited Systemic AEs for 7 Days Following the First Single Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Main Part: 7 days after the first single booster vaccination', 'description': 'Solicited systemic AEs were defined as fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting, and headache.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Main Part: The safety analysis set included all participants who received at least 1 dose of the trial vaccination.'}, {'type': 'PRIMARY', 'title': 'Main Part: Percentage of Participants With Unsolicited AEs for 28 Days Following the First Single Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.67', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Main Part: 28 days after the first single booster vaccination', 'description': 'Unsolicited AEs defines as other AEs than solicited local AEs and solicited systemic AEs.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Main Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'PRIMARY', 'title': 'Main Part: Percentage of Participants With Solicited and Unsolicited Serious Adverse Events (SAE) Until Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'title': 'Solicited SAEs up to Day 29', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unsolicited SAEs up to Day 29', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Main Part: Up to Day 29', 'description': 'An SAE was defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event. Solicited SAEs and unsolicited SAEs were reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Main Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'PRIMARY', 'title': 'Main Part: Percentage of Participants With Adverse Event of Special Interest (AESI) Until Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Main Part: Up to Day 29', 'description': 'An AESI was defined as AEs that will be specifically highlighted to the Investigator. AESIs for the study included the Potential Immune Mediated Medical Conditions (PIMMC) and AEs specific to COVID-19. PIMMC is categorized as following; neuroinflammatory disorders, musculoskeletal and connective tissue disorders, vasculitides, gastrointestinal disorders, hepatic disorders, renal disorders, cardiac disorders, skin disorder, hematologic disorders, metabolic disorders, and other disorders.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Main Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'PRIMARY', 'title': 'Main Part: Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Main Part: Up to Day 29', 'description': 'MAAEs were defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Main Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'PRIMARY', 'title': 'Main Part: Percentage of Participants With Any AE Leading to Withdrawal From the Trial Until Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Main Part: Up to Day 29', 'description': 'Percentage of participants with any AE leading to withdrawal from the trial until Day 29 was reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Main Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'PRIMARY', 'title': 'Main Part: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Main Part: Up to Day 29', 'description': 'Percentage of participants with SARS-CoV-2 infection until Day 29 of the main part of the trial were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Main Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'SECONDARY', 'title': 'Main Part: GMT of Serum Immunoglobulin G (IgG) Antibody Levels to SARS-CoV-2 Recombinant Spike (rS) Protein on Day 8, 15, 29, 91, 181, and 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'title': 'At Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24705.9', 'groupId': 'OG000', 'lowerLimit': '21894.6', 'upperLimit': '27878.2'}]}]}, {'title': 'At Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35202.2', 'groupId': 'OG000', 'lowerLimit': '31508.4', 'upperLimit': '39329.1'}]}]}, {'title': 'At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36138.3', 'groupId': 'OG000', 'lowerLimit': '32143.8', 'upperLimit': '40629.2'}]}]}, {'title': 'At Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26420.8', 'groupId': 'OG000', 'lowerLimit': '23137.2', 'upperLimit': '30170.4'}]}]}, {'title': 'At Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20246.3', 'groupId': 'OG000', 'lowerLimit': '11976.5', 'upperLimit': '34226.5'}]}]}, {'title': 'At Day 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31369.4', 'groupId': 'OG000', 'lowerLimit': '15135.7', 'upperLimit': '65014.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Main Part: Day 8, 15, 29, 91, 181, and 366', 'description': 'GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ. LLOQ was equal to 200 EU/mL.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Set: PPS was defined to include participants in the FAS and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Main Part: Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 8, 15, 29, 91, 181, and 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'title': 'At Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.21', 'groupId': 'OG000', 'lowerLimit': '3.69', 'upperLimit': '4.81'}]}]}, {'title': 'At Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000', 'lowerLimit': '5.17', 'upperLimit': '6.97'}]}]}, {'title': 'At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.16', 'groupId': 'OG000', 'lowerLimit': '5.23', 'upperLimit': '7.27'}]}]}, {'title': 'At Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.43', 'groupId': 'OG000', 'lowerLimit': '3.67', 'upperLimit': '5.36'}]}]}, {'title': 'At Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.96', 'groupId': 'OG000', 'lowerLimit': '1.45', 'upperLimit': '6.04'}]}]}, {'title': 'At Day 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.28', 'groupId': 'OG000', 'lowerLimit': '1.33', 'upperLimit': '13.77'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Main Part: Day 8, 15, 29, 91, 181, and 366', 'description': 'GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Where baseline was defined as the last measurement taken before the first dose of trial vaccination.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Set: PPS was defined to include participants in the FAS and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, number analyzed signifies participants who were evaluable at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Main Part: Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 8, 15, 29, 91, 181, and 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'title': 'At Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.4', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '61.6'}]}]}, {'title': 'At Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.9', 'groupId': 'OG000', 'lowerLimit': '62.9', 'upperLimit': '78.1'}]}]}, {'title': 'At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.3', 'groupId': 'OG000', 'lowerLimit': '62.2', 'upperLimit': '77.5'}]}]}, {'title': 'At Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000', 'lowerLimit': '47.5', 'upperLimit': '64.5'}]}]}, {'title': 'At Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '16.3', 'upperLimit': '67.7'}]}]}, {'title': 'At Day 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '31.6', 'upperLimit': '86.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Main Part: Day 8, 15, 29, 91, 181, and 366', 'description': 'SCR was defined as percentage of participants with 4-fold or more rises from baseline in titer. Baseline was defined as the last measurement taken before the first dose of trial vaccination.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Set: PPS was defined to include participants in the FAS and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, number analyzed signifies participants who were evaluable at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Main Part: GMT of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'title': 'At Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '729.7', 'groupId': 'OG000', 'lowerLimit': '634.5', 'upperLimit': '839.2'}]}]}, {'title': 'At Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1143.9', 'groupId': 'OG000', 'lowerLimit': '1000.5', 'upperLimit': '1307.9'}]}]}, {'title': 'At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '775.5', 'groupId': 'OG000', 'lowerLimit': '693.8', 'upperLimit': '866.8'}]}]}, {'title': 'At Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '656.2', 'groupId': 'OG000', 'lowerLimit': '559.6', 'upperLimit': '769.4'}]}]}, {'title': 'At Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '844.5', 'groupId': 'OG000', 'lowerLimit': '410.0', 'upperLimit': '1739.3'}]}]}, {'title': 'At Day 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1424.0', 'groupId': 'OG000', 'lowerLimit': '597.0', 'upperLimit': '3396.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Main Part: Day 8, 15, 29, 91, 181, and 366', 'description': 'The neutralization titer was expressed as the reciprocal of the highest dilution at which greater than or equal to (\\>=) 50 percent (%) of the replicate wells were protected from infection (microneutralization \\[MN\\] with an inhibitory concentration of 50% \\[MN50\\]). GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ where LLOQ was equal to 20.', 'unitOfMeasure': '1 per dilution', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Set: PPS was defined to include participants in the FAS and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, number analyzed signifies participants who were evaluable at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Main Part: GMFR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'title': 'At Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.32', 'groupId': 'OG000', 'lowerLimit': '4.55', 'upperLimit': '6.23'}]}]}, {'title': 'At Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.34', 'groupId': 'OG000', 'lowerLimit': '6.93', 'upperLimit': '10.04'}]}]}, {'title': 'At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.66', 'groupId': 'OG000', 'lowerLimit': '4.68', 'upperLimit': '6.84'}]}]}, {'title': 'At Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.72', 'groupId': 'OG000', 'lowerLimit': '3.72', 'upperLimit': '5.97'}]}]}, {'title': 'At Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.79', 'groupId': 'OG000', 'lowerLimit': '2.43', 'upperLimit': '13.80'}]}]}, {'title': 'At Day 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.90', 'groupId': 'OG000', 'lowerLimit': '2.84', 'upperLimit': '34.54'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Main Part: Day 8, 15, 29, 91, 181, and 366', 'description': 'The neutralization titer was expressed as the reciprocal of the highest dilution at which \\>=50% of the replicate wells were protected from infection (MN50). GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Baseline was defined as the last measurement taken before the first dose of trial vaccination.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Set: PPS was defined to include participants in the FAS and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, number analyzed signifies participants who were evaluable at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Main Part: SCR of Serum Neutralizing Antibody Titters to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'title': 'At Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.7', 'groupId': 'OG000', 'lowerLimit': '70.1', 'upperLimit': '84.1'}]}]}, {'title': 'At Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.5', 'groupId': 'OG000', 'lowerLimit': '77.6', 'upperLimit': '89.9'}]}]}, {'title': 'At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.7', 'groupId': 'OG000', 'lowerLimit': '67.9', 'upperLimit': '82.3'}]}]}, {'title': 'At Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000', 'lowerLimit': '59.2', 'upperLimit': '75.3'}]}]}, {'title': 'At Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '38.4', 'upperLimit': '88.2'}]}]}, {'title': 'At Day 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000', 'lowerLimit': '46.2', 'upperLimit': '95.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Main Part: Day 8, 15, 29, 91, 181, and 366', 'description': 'The neutralization titer was expressed as the reciprocal of the highest dilution at which greater than or equal to (\\>=) 50% of the replicate wells were protected from infection (MN50). SCR was defined as percentage of participants with 4-fold or more rises in from baseline. Baseline was defined as the last measurement taken before the first dose of trial vaccination.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Set: PPS was defined to include participants in the FAS and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, number analyzed signifies participants who were evaluable at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Main Part: Percentage of Participants With Solicited and Unsolicited SAEs Throughout the Main Part of Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'title': 'Solicited SAEs Throughout the Main Part of Trial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unsolicited SAEs Throughout the Main Part of Trial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Main Part: Up to Day 366', 'description': 'An SAE was defined as any untoward medical occurrence that: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event. Solicited SAEs and unsolicited SAEs were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Main Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'SECONDARY', 'title': 'Main Part: Percentage of Participants With AESI Throughout the Main Part of Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Main Part: Up to Day 366', 'description': 'An AESI was defined as AEs that will be specifically highlighted to the Investigator. AESIs for the study included the PIMMC and AEs specific to COVID-19. PIMMC is categorized as following; neuroinflammatory disorders, musculoskeletal and connective tissue disorders, vasculitides, gastrointestinal disorders, hepatic disorders, renal disorders, cardiac disorders, skin disorder, hematologic disorders, metabolic disorders, and other disorders.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Main Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'SECONDARY', 'title': 'Main Part: Percentage of Participants With MAAEs Throughout the Main Part of Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Main Part: Up to Day 366', 'description': 'MAAEs were defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Main Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'SECONDARY', 'title': "Main Part: Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial From the Day of the First Single Booster Vaccination Throughout the Main Part of Trial", 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Main Part: Day 1 up to Day 366', 'description': "Percentage of participants with any AE leading to participant's withdrawal from the trial from the day of the first single booster vaccination throughout the main part of trial was reported.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Main Part: The safety analysis set included all participants who received at least 1 dose of the trial vaccination.'}, {'type': 'SECONDARY', 'title': 'Main Part: Percentage of Participants With SARS-CoV-2 Infection Throughout the Main Part of Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Main Part: Day 1 up to Day 366', 'description': 'Percentage of participants with SARS-CoV-2 infection throughout the main part of trial was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Main Part: The safety analysis set included all participants who received at least 1 dose of the trial vaccination.'}, {'type': 'SECONDARY', 'title': 'Extension Part: GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 15, 29, 91, 181, and 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'title': 'At Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '105057.6', 'groupId': 'OG000', 'lowerLimit': '91624.1', 'upperLimit': '120460.6'}]}]}, {'title': 'At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88154.1', 'groupId': 'OG000', 'lowerLimit': '77487.0', 'upperLimit': '100289.7'}]}]}, {'title': 'At Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61090.0', 'groupId': 'OG000', 'lowerLimit': '52488.3', 'upperLimit': '71101.2'}]}]}, {'title': 'At Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46199.1', 'groupId': 'OG000', 'lowerLimit': '38752.6', 'upperLimit': '55076.6'}]}]}, {'title': 'At Day 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62823.7', 'groupId': 'OG000', 'lowerLimit': '51897.3', 'upperLimit': '76050.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Extension Part: Day 15, 29, 91, 181, and 366', 'description': 'GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ. LLOQ was equal to 200 EU/mL.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Part PPS was defined to include participants in the FAS in the Extension Part who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, "overall number of participants analyzed" signified participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Extension Part: GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Extension Part Day 15, 29, 91, 181, and 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'title': 'At Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.99', 'groupId': 'OG000', 'lowerLimit': '3.47', 'upperLimit': '4.59'}]}]}, {'title': 'At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.32', 'groupId': 'OG000', 'lowerLimit': '2.91', 'upperLimit': '3.78'}]}]}, {'title': 'At Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.30', 'groupId': 'OG000', 'lowerLimit': '1.96', 'upperLimit': '2.70'}]}]}, {'title': 'At Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.72', 'groupId': 'OG000', 'lowerLimit': '1.43', 'upperLimit': '2.08'}]}]}, {'title': 'At Day 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.33', 'groupId': 'OG000', 'lowerLimit': '1.84', 'upperLimit': '2.95'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Extension Part: Day 15, 29, 91, 181, and 366', 'description': 'The GMFR was calculated as the ratio of the post-second-booster-vaccination titer level to extension part baseline titer level. Where extension part baseline was defined as last measurement taken before the second booster vaccination.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension part PPS was defined to include participants in the FAS in the Extension Part who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, "overall number of participants analyzed" signified participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Extension Part: Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Extension Part Day 15, 29, 91, 181, and 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'title': 'At Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000', 'lowerLimit': '41.7', 'upperLimit': '61.0'}]}]}, {'title': 'At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000', 'lowerLimit': '31.6', 'upperLimit': '50.7'}]}]}, {'title': 'At Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': '28.4'}]}]}, {'title': 'At Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '25.3'}]}]}, {'title': 'At Day 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000', 'lowerLimit': '19.8', 'upperLimit': '39.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension Part: Day 15, 29, 91, 181, and 366', 'description': 'SCR was defined as percentage of participants with 4-fold or more rises in titer from extension part baseline. Where extension part baseline was defined as last measurement taken before the second booster vaccination.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension part PPS was defined to include participants in the FAS in the Extension Part who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, "overall number of participants analyzed" signified participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Extension Part: GMT of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, 29, 91, 181, and 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'title': 'At Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1716.6', 'groupId': 'OG000', 'lowerLimit': '1463.2', 'upperLimit': '2013.9'}]}]}, {'title': 'At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1732.1', 'groupId': 'OG000', 'lowerLimit': '1465.8', 'upperLimit': '2046.8'}]}]}, {'title': 'At Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1255.4', 'groupId': 'OG000', 'lowerLimit': '1019.2', 'upperLimit': '1546.3'}]}]}, {'title': 'At Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1360.7', 'groupId': 'OG000', 'lowerLimit': '1081.2', 'upperLimit': '1712.6'}]}]}, {'title': 'At Day 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '660.0', 'groupId': 'OG000', 'lowerLimit': '531.0', 'upperLimit': '820.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Extension Part: Day 15, 29, 91, 181, and 366', 'description': 'The neutralization titer was expressed as the reciprocal of the highest dilution at \\>= 50% of the replicate wells were protected from infection (MN50). GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ where LLOQ was equal to 20.', 'unitOfMeasure': '1 per dilution', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension part PPS was defined to include participants in the FAS in the Extension Part who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, "overall number of participants analyzed" signified participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Extension Part: GMFR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, 29, 91, 181, and 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'title': 'At Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.04', 'groupId': 'OG000', 'lowerLimit': '2.59', 'upperLimit': '3.57'}]}]}, {'title': 'At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.05', 'groupId': 'OG000', 'lowerLimit': '2.57', 'upperLimit': '3.63'}]}]}, {'title': 'At Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.19', 'groupId': 'OG000', 'lowerLimit': '1.81', 'upperLimit': '2.66'}]}]}, {'title': 'At Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.34', 'groupId': 'OG000', 'lowerLimit': '1.86', 'upperLimit': '2.94'}]}]}, {'title': 'At Day 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.16', 'groupId': 'OG000', 'lowerLimit': '0.86', 'upperLimit': '1.55'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Extension Part: Day 15, 29, 91, 181, and 366', 'description': 'The neutralization titer was expressed as the reciprocal of the highest dilution at \\>= 50% of the replicate wells were protected from infection (MN50). The GMFR was calculated as the ratio of the post-second-booster-vaccination titer level to extension part baseline titer level. Where extension part baseline was defined as last measurement taken before the second booster vaccination.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension part PPS was defined to include participants in the FAS in the Extension Part who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, "overall number of participants analyzed" signified participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Extension Part: SCR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, 29, 91, 181, and 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'title': 'At Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000', 'lowerLimit': '41.7', 'upperLimit': '61.0'}]}]}, {'title': 'At Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.7', 'groupId': 'OG000', 'lowerLimit': '43.0', 'upperLimit': '62.3'}]}]}, {'title': 'At Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000', 'lowerLimit': '22.3', 'upperLimit': '40.5'}]}]}, {'title': 'At Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.3', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '46.4'}]}]}, {'title': 'At Day 366', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '34.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension Part: Day 15, 29, 91, 181, and 366', 'description': 'The neutralization titer was expressed as the reciprocal of the highest dilution at \\>= 50% of the replicate wells were protected from infection (MN50). SCR was defined as percentage of participants with 4-fold or more rises in titer from extension part baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension part PPS was defined to include participants in the FAS in the Extension Part who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, "overall number of participants analyzed" signified participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Extension Part: Percentage of Participants With Reported Solicited Local AEs for 7 Days Following the Second Single Booster Vaccination in Extension Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension Part: 7 days after the second single booster vaccination', 'description': 'AE was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product (IMP); it did not necessarily have to have a causal relationship with IMP administration. Reported solicited local AEs were defined as injection site pain, tenderness, erythema/redness, induration, and swelling.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'SECONDARY', 'title': 'Extension Part: Percentage of Participants With Solicited Systemic AEs for 7 Days Following the Second Single Booster Vaccination in Extension Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension Part: 7 days after the second single booster vaccination', 'description': 'Solicited systemic AEs included were defined as fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting and headache.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'SECONDARY', 'title': 'Extension Part: Percentage of Participants With Unsolicited AEs for 28 Days Following the Second Single Booster Vaccination in Extension Part', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension Part: 28 days after the second single booster vaccination', 'description': 'Unsolicited AEs defined as AEs other than solicited local AEs and solicited systemic AEs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'SECONDARY', 'title': 'Extension Part: Percentage of Participants With Solicited and Unsolicited SAEs Until Extension Part Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'title': 'Solicited SAEs Up to Extension Part Day 29', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unsolicited SAEs Up to Extension Part Day 29', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension Part: Up to Day 29', 'description': 'An SAE was defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event. Solicited SAEs and unsolicited SAEs were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'SECONDARY', 'title': 'Extension Part: Percentage of Participants With AESIs Until Extension Part Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension Part: Up to Day 29', 'description': 'An AESI was defined as AEs that will be specifically highlighted to the investigator. AESIs for the study included the PIMMC and AEs specific to COVID-19. PIMMC is categorized as following; neuroinflammatory disorders, musculoskeletal and connective tissue disorders, vasculitides, gastrointestinal disorders, hepatic disorders, renal disorders, cardiac disorders, skin disorder, hematologic disorders, metabolic disorders, and other disorders.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'SECONDARY', 'title': 'Extension Part: Percentage of Participants With MAAEs Until Extension Part Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension Part: Up to Day 29', 'description': 'MAAEs were defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'SECONDARY', 'title': 'Extension Part: Percentage of Participants With Any AEs Leading to Withdrawal From the Trial Until Extension Part Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension Part: Up to Day 29', 'description': 'Percentage of participants with any AEs leading to withdrawal from the trial until extension part Day 29 was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'SECONDARY', 'title': 'Extension Part: Percentage of Participants With SARS-CoV-2 Infection Until Extension Part Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension Part: Up to Day 29', 'description': 'Percentage of participants with SARS-CoV-2 infection until extension part Day 29 was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'SECONDARY', 'title': 'Extension Part: Percentage of Participants With Solicited and Unsolicited SAEs Throughout the Extension Part of the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'title': 'Solicited SAEs Throughout the Extension Part', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unsolicited SAEs Throughout the Extension Part', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension Part: Up to Day 366', 'description': 'An SAE was defined as any untoward medical occurrence that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Leads to a congenital anomaly/birth defect in the offspring of a participant, or Is an important medical event. Solicited SAEs and unsolicited SAEs were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'SECONDARY', 'title': 'Extension Part: Percentage of Participants With AESIs Throughout the Extension Part of the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension Part: Up to Day 366', 'description': 'An AESI was defined as AEs that will be specifically highlighted to the Investigator. AESIs for the study included the PIMMC and AEs specific to COVID-19. PIMMC is categorized as following; neuroinflammatory disorders, musculoskeletal and connective tissue disorders, vasculitides, gastrointestinal disorders, hepatic disorders, renal disorders, cardiac disorders, skin disorder, hematologic disorders, metabolic disorders, and other disorders.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'SECONDARY', 'title': 'Extension Part: Percentage of Participants With MAAEs Throughout the Extension Part of the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension Part: Up to Day 366', 'description': 'MAAEs were defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'SECONDARY', 'title': 'Extension Part: Percentage of Participants With Any AEs Leading to Withdrawal From the Trial From the Day of the Second Single Booster Vaccination Throughout the Extension Part of the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension Part: From Day 1 up to Day 366', 'description': 'Percentage of participants with any AEs leading to withdrawal from the trial from the day of the second single booster vaccination throughout the extension part of the trial was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}, {'type': 'SECONDARY', 'title': 'Extension Part: Percentage of Participants With SARS-CoV-2 Infection Throughout the Extension Part of Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extension Part: TAK-019', 'description': 'Participants received TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension part.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension Part: Up to Day 366', 'description': 'Percentage of participants with SARS-CoV-2 infection throughout the extension part of trial was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Part: The safety analysis set included all participants who received at least 1 dose of trial vaccination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 milliliter (mL), intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}, {'id': 'FG001', 'title': 'Extension Part: TAK-019', 'description': 'Participants received a second booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension Part.'}], 'periods': [{'title': 'Main Part: Day 1 up to Day 366', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Participants moved to extension part', 'reasons': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Extension Part: Day 1 to Day 366', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants who had received the first single booster vaccination of TAK-019 in the Main Part and remained in study follow-up for at least 5 months were offered second single booster vaccination of TAK-019 in Extension Part.', 'groupId': 'FG001', 'numSubjects': '129'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '121'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 2 investigative sites in Japan. Healthy Japanese participants who completed 2 doses of primary vaccinations 6 to 12 months prior to trial vaccination were enrolled to receive a first dose of single booster vaccination of TAK-019 in Main Part and a second dose of booster vaccination of TAK-019 in Extension Part.', 'preAssignmentDetails': 'Participants were followed for up to 12 months after each vaccination in both parts. However, participants who remained for at least 5 months in Main Part were offered second single booster vaccination of TAK-019 in Extension Part, leading to a total participation duration of approximately 17 months.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Main Part: TAK-019', 'description': 'Participants received a first single booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.7', 'spread': '13.00', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '150', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'categories': [{'title': 'Japan', 'measurements': [{'value': '150', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '61.70', 'spread': '11.497', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '164.47', 'spread': '9.408', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeter (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '22.68', 'spread': '2.940', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilogram (kg)/meter (m)^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Main Part: The safety analysis set included all participants who received at least 1 dose of the trial vaccination.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-29', 'size': 1601771, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-06T23:04', 'hasProtocol': True}, {'date': '2023-05-23', 'size': 2254898, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-18T23:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-18', 'studyFirstSubmitDate': '2022-03-27', 'resultsFirstSubmitDate': '2023-06-06', 'studyFirstSubmitQcDate': '2022-03-27', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-07', 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Main Part: Geometric Mean Titers (GMT) Ratio of Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Day 15 Compared With That Observed on Day 36 in Participants From the TAK-019-1501 Study', 'timeFrame': 'Day 15 for this study (14 days after the vaccination); Day 36 for TAK-019-1501 study (14 days after the second vaccination)', 'description': 'GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values was measured as below lower limit of quantification (LLOQ) were imputed to a value that was half of the LLOQ. LLOQ was equal to 20. GMT for each group and GMT ratio of neutralizing antibody titers to the ancestral strain (wild-type virus) on Day15 after a single booster vaccination (14 days after the booster vaccination) compared with that observed on Day 36 (14 days after the second vaccination) in participants from the TAK-019-1501 study (NCT04712110) were reported. GMT ratio was calculated with GMT of TAK-019-3001 on Day 15 divided by GMT of TAK-019-1501 study on Day 36. Here, ELISA is Enzyme-linked immunosorbent assay.'}, {'measure': 'Main Part: Percentage of Participants With Reported Solicited Local Adverse Events (AEs) for 7 Days Following the First Single Booster Vaccination', 'timeFrame': 'Main Part: 7 days after the first single booster vaccination', 'description': 'AE was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product (IMP); it did not necessarily have to have a causal relationship with IMP administration. Reported solicited local AEs were defined as injection site pain, tenderness, erythema/redness, induration, and swelling.'}, {'measure': 'Main Part: Percentage of Participants With Solicited Systemic AEs for 7 Days Following the First Single Booster Vaccination', 'timeFrame': 'Main Part: 7 days after the first single booster vaccination', 'description': 'Solicited systemic AEs were defined as fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting, and headache.'}, {'measure': 'Main Part: Percentage of Participants With Unsolicited AEs for 28 Days Following the First Single Booster Vaccination', 'timeFrame': 'Main Part: 28 days after the first single booster vaccination', 'description': 'Unsolicited AEs defines as other AEs than solicited local AEs and solicited systemic AEs.'}, {'measure': 'Main Part: Percentage of Participants With Solicited and Unsolicited Serious Adverse Events (SAE) Until Day 29', 'timeFrame': 'Main Part: Up to Day 29', 'description': 'An SAE was defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event. Solicited SAEs and unsolicited SAEs were reported.'}, {'measure': 'Main Part: Percentage of Participants With Adverse Event of Special Interest (AESI) Until Day 29', 'timeFrame': 'Main Part: Up to Day 29', 'description': 'An AESI was defined as AEs that will be specifically highlighted to the Investigator. AESIs for the study included the Potential Immune Mediated Medical Conditions (PIMMC) and AEs specific to COVID-19. PIMMC is categorized as following; neuroinflammatory disorders, musculoskeletal and connective tissue disorders, vasculitides, gastrointestinal disorders, hepatic disorders, renal disorders, cardiac disorders, skin disorder, hematologic disorders, metabolic disorders, and other disorders.'}, {'measure': 'Main Part: Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 29', 'timeFrame': 'Main Part: Up to Day 29', 'description': 'MAAEs were defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria.'}, {'measure': 'Main Part: Percentage of Participants With Any AE Leading to Withdrawal From the Trial Until Day 29', 'timeFrame': 'Main Part: Up to Day 29', 'description': 'Percentage of participants with any AE leading to withdrawal from the trial until Day 29 was reported.'}, {'measure': 'Main Part: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 29', 'timeFrame': 'Main Part: Up to Day 29', 'description': 'Percentage of participants with SARS-CoV-2 infection until Day 29 of the main part of the trial were reported in this outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Main Part: GMT of Serum Immunoglobulin G (IgG) Antibody Levels to SARS-CoV-2 Recombinant Spike (rS) Protein on Day 8, 15, 29, 91, 181, and 366', 'timeFrame': 'Main Part: Day 8, 15, 29, 91, 181, and 366', 'description': 'GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ. LLOQ was equal to 200 EU/mL.'}, {'measure': 'Main Part: Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 8, 15, 29, 91, 181, and 366', 'timeFrame': 'Main Part: Day 8, 15, 29, 91, 181, and 366', 'description': 'GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Where baseline was defined as the last measurement taken before the first dose of trial vaccination.'}, {'measure': 'Main Part: Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 8, 15, 29, 91, 181, and 366', 'timeFrame': 'Main Part: Day 8, 15, 29, 91, 181, and 366', 'description': 'SCR was defined as percentage of participants with 4-fold or more rises from baseline in titer. Baseline was defined as the last measurement taken before the first dose of trial vaccination.'}, {'measure': 'Main Part: GMT of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366', 'timeFrame': 'Main Part: Day 8, 15, 29, 91, 181, and 366', 'description': 'The neutralization titer was expressed as the reciprocal of the highest dilution at which greater than or equal to (\\>=) 50 percent (%) of the replicate wells were protected from infection (microneutralization \\[MN\\] with an inhibitory concentration of 50% \\[MN50\\]). GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ where LLOQ was equal to 20.'}, {'measure': 'Main Part: GMFR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366', 'timeFrame': 'Main Part: Day 8, 15, 29, 91, 181, and 366', 'description': 'The neutralization titer was expressed as the reciprocal of the highest dilution at which \\>=50% of the replicate wells were protected from infection (MN50). GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Baseline was defined as the last measurement taken before the first dose of trial vaccination.'}, {'measure': 'Main Part: SCR of Serum Neutralizing Antibody Titters to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366', 'timeFrame': 'Main Part: Day 8, 15, 29, 91, 181, and 366', 'description': 'The neutralization titer was expressed as the reciprocal of the highest dilution at which greater than or equal to (\\>=) 50% of the replicate wells were protected from infection (MN50). SCR was defined as percentage of participants with 4-fold or more rises in from baseline. Baseline was defined as the last measurement taken before the first dose of trial vaccination.'}, {'measure': 'Main Part: Percentage of Participants With Solicited and Unsolicited SAEs Throughout the Main Part of Trial', 'timeFrame': 'Main Part: Up to Day 366', 'description': 'An SAE was defined as any untoward medical occurrence that: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event. Solicited SAEs and unsolicited SAEs were reported.'}, {'measure': 'Main Part: Percentage of Participants With AESI Throughout the Main Part of Trial', 'timeFrame': 'Main Part: Up to Day 366', 'description': 'An AESI was defined as AEs that will be specifically highlighted to the Investigator. AESIs for the study included the PIMMC and AEs specific to COVID-19. PIMMC is categorized as following; neuroinflammatory disorders, musculoskeletal and connective tissue disorders, vasculitides, gastrointestinal disorders, hepatic disorders, renal disorders, cardiac disorders, skin disorder, hematologic disorders, metabolic disorders, and other disorders.'}, {'measure': 'Main Part: Percentage of Participants With MAAEs Throughout the Main Part of Trial', 'timeFrame': 'Main Part: Up to Day 366', 'description': 'MAAEs were defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria.'}, {'measure': "Main Part: Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial From the Day of the First Single Booster Vaccination Throughout the Main Part of Trial", 'timeFrame': 'Main Part: Day 1 up to Day 366', 'description': "Percentage of participants with any AE leading to participant's withdrawal from the trial from the day of the first single booster vaccination throughout the main part of trial was reported."}, {'measure': 'Main Part: Percentage of Participants With SARS-CoV-2 Infection Throughout the Main Part of Trial', 'timeFrame': 'Main Part: Day 1 up to Day 366', 'description': 'Percentage of participants with SARS-CoV-2 infection throughout the main part of trial was reported.'}, {'measure': 'Extension Part: GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 15, 29, 91, 181, and 366', 'timeFrame': 'Extension Part: Day 15, 29, 91, 181, and 366', 'description': 'GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ. LLOQ was equal to 200 EU/mL.'}, {'measure': 'Extension Part: GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Extension Part Day 15, 29, 91, 181, and 366', 'timeFrame': 'Extension Part: Day 15, 29, 91, 181, and 366', 'description': 'The GMFR was calculated as the ratio of the post-second-booster-vaccination titer level to extension part baseline titer level. Where extension part baseline was defined as last measurement taken before the second booster vaccination.'}, {'measure': 'Extension Part: Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Extension Part Day 15, 29, 91, 181, and 366', 'timeFrame': 'Extension Part: Day 15, 29, 91, 181, and 366', 'description': 'SCR was defined as percentage of participants with 4-fold or more rises in titer from extension part baseline. Where extension part baseline was defined as last measurement taken before the second booster vaccination.'}, {'measure': 'Extension Part: GMT of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, 29, 91, 181, and 366', 'timeFrame': 'Extension Part: Day 15, 29, 91, 181, and 366', 'description': 'The neutralization titer was expressed as the reciprocal of the highest dilution at \\>= 50% of the replicate wells were protected from infection (MN50). GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ where LLOQ was equal to 20.'}, {'measure': 'Extension Part: GMFR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, 29, 91, 181, and 366', 'timeFrame': 'Extension Part: Day 15, 29, 91, 181, and 366', 'description': 'The neutralization titer was expressed as the reciprocal of the highest dilution at \\>= 50% of the replicate wells were protected from infection (MN50). The GMFR was calculated as the ratio of the post-second-booster-vaccination titer level to extension part baseline titer level. Where extension part baseline was defined as last measurement taken before the second booster vaccination.'}, {'measure': 'Extension Part: SCR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, 29, 91, 181, and 366', 'timeFrame': 'Extension Part: Day 15, 29, 91, 181, and 366', 'description': 'The neutralization titer was expressed as the reciprocal of the highest dilution at \\>= 50% of the replicate wells were protected from infection (MN50). SCR was defined as percentage of participants with 4-fold or more rises in titer from extension part baseline.'}, {'measure': 'Extension Part: Percentage of Participants With Reported Solicited Local AEs for 7 Days Following the Second Single Booster Vaccination in Extension Part', 'timeFrame': 'Extension Part: 7 days after the second single booster vaccination', 'description': 'AE was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product (IMP); it did not necessarily have to have a causal relationship with IMP administration. Reported solicited local AEs were defined as injection site pain, tenderness, erythema/redness, induration, and swelling.'}, {'measure': 'Extension Part: Percentage of Participants With Solicited Systemic AEs for 7 Days Following the Second Single Booster Vaccination in Extension Part', 'timeFrame': 'Extension Part: 7 days after the second single booster vaccination', 'description': 'Solicited systemic AEs included were defined as fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting and headache.'}, {'measure': 'Extension Part: Percentage of Participants With Unsolicited AEs for 28 Days Following the Second Single Booster Vaccination in Extension Part', 'timeFrame': 'Extension Part: 28 days after the second single booster vaccination', 'description': 'Unsolicited AEs defined as AEs other than solicited local AEs and solicited systemic AEs.'}, {'measure': 'Extension Part: Percentage of Participants With Solicited and Unsolicited SAEs Until Extension Part Day 29', 'timeFrame': 'Extension Part: Up to Day 29', 'description': 'An SAE was defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event. Solicited SAEs and unsolicited SAEs were reported.'}, {'measure': 'Extension Part: Percentage of Participants With AESIs Until Extension Part Day 29', 'timeFrame': 'Extension Part: Up to Day 29', 'description': 'An AESI was defined as AEs that will be specifically highlighted to the investigator. AESIs for the study included the PIMMC and AEs specific to COVID-19. PIMMC is categorized as following; neuroinflammatory disorders, musculoskeletal and connective tissue disorders, vasculitides, gastrointestinal disorders, hepatic disorders, renal disorders, cardiac disorders, skin disorder, hematologic disorders, metabolic disorders, and other disorders.'}, {'measure': 'Extension Part: Percentage of Participants With MAAEs Until Extension Part Day 29', 'timeFrame': 'Extension Part: Up to Day 29', 'description': 'MAAEs were defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria.'}, {'measure': 'Extension Part: Percentage of Participants With Any AEs Leading to Withdrawal From the Trial Until Extension Part Day 29', 'timeFrame': 'Extension Part: Up to Day 29', 'description': 'Percentage of participants with any AEs leading to withdrawal from the trial until extension part Day 29 was reported.'}, {'measure': 'Extension Part: Percentage of Participants With SARS-CoV-2 Infection Until Extension Part Day 29', 'timeFrame': 'Extension Part: Up to Day 29', 'description': 'Percentage of participants with SARS-CoV-2 infection until extension part Day 29 was reported.'}, {'measure': 'Extension Part: Percentage of Participants With Solicited and Unsolicited SAEs Throughout the Extension Part of the Trial', 'timeFrame': 'Extension Part: Up to Day 366', 'description': 'An SAE was defined as any untoward medical occurrence that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Leads to a congenital anomaly/birth defect in the offspring of a participant, or Is an important medical event. Solicited SAEs and unsolicited SAEs were reported.'}, {'measure': 'Extension Part: Percentage of Participants With AESIs Throughout the Extension Part of the Trial', 'timeFrame': 'Extension Part: Up to Day 366', 'description': 'An AESI was defined as AEs that will be specifically highlighted to the Investigator. AESIs for the study included the PIMMC and AEs specific to COVID-19. PIMMC is categorized as following; neuroinflammatory disorders, musculoskeletal and connective tissue disorders, vasculitides, gastrointestinal disorders, hepatic disorders, renal disorders, cardiac disorders, skin disorder, hematologic disorders, metabolic disorders, and other disorders.'}, {'measure': 'Extension Part: Percentage of Participants With MAAEs Throughout the Extension Part of the Trial', 'timeFrame': 'Extension Part: Up to Day 366', 'description': 'MAAEs were defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria.'}, {'measure': 'Extension Part: Percentage of Participants With Any AEs Leading to Withdrawal From the Trial From the Day of the Second Single Booster Vaccination Throughout the Extension Part of the Trial', 'timeFrame': 'Extension Part: From Day 1 up to Day 366', 'description': 'Percentage of participants with any AEs leading to withdrawal from the trial from the day of the second single booster vaccination throughout the extension part of the trial was reported.'}, {'measure': 'Extension Part: Percentage of Participants With SARS-CoV-2 Infection Throughout the Extension Part of Trial', 'timeFrame': 'Extension Part: Up to Day 366', 'description': 'Percentage of participants with SARS-CoV-2 infection throughout the extension part of trial was reported.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus Disease (COVID-19)']}, 'referencesModule': {'references': [{'pmid': '38129286', 'type': 'DERIVED', 'citation': 'Kuriyama K, Murakami K, Sugiura K, Sakui S, Schuring RP, Mori M. Immunogenicity and safety of a second heterologous booster dose of NVX-CoV2373 (TAK-019) in healthy Japanese adults who had previously received a primary series of COVID-19 mRNA vaccine: Interim analysis report of a phase 3 open-label trial. Vaccine. 2024 Jan 25;42(3):662-670. doi: 10.1016/j.vaccine.2023.12.036. Epub 2023 Dec 21.'}, {'pmid': '37198021', 'type': 'DERIVED', 'citation': 'Kuriyama K, Murakami K, Masuda T, Sugiura K, Sakui S, Schuring RP, Mori M. Immunogenicity and safety of a single booster dose of NVX-CoV2373 (TAK-019) in healthy Japanese adults who had previously received a primary series of COVID-19 mRNA vaccine: Primary analysis report of a phase 3 open-label trial. Vaccine. 2023 Jun 7;41(25):3763-3771. doi: 10.1016/j.vaccine.2023.05.001. Epub 2023 May 8.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/234514379776426d?id=', 'label': 'To obtain more information on the study, click here/on this link'}]}, 'descriptionModule': {'briefSummary': 'TAK-019 is a vaccine in development to protect people against Covid-19. The main aims of the study are to learn if TAK-019 can protect people from Covid-19 and to check for side effects from TAK-019 for participants who will receive TAK-019 as heterologous booster vaccination.\n\nThis study consists of two parts, main part and extension part. Firstly, participants who completed 2 doses primary vaccinations 6 to 12 months prior to the trial vaccination can take part in main study. At the first visit of main part of this study, the study doctor will check if each person can take part. Participants who can take part will receive an injection of TAK-019 as booster vaccination.\n\nParticipants will be asked to record their temperature and any medical problems in an electronic diary for up to 7 days after the injection. During the main part, participants will visit the clinic for regular check-ups, blood tests, and sometimes for nose swab samples. When all participants have attended a clinic visit 28 days after the injection, the study sponsor (Takeda) will check how many participants have made enough antibodies to protect them against Covid-19.\n\nParticipants who received the first single booster vaccination of TAK-019 in the main part and remained in study follow-up at least 5 months will be able to decide to take part in the extension part of this study. At the first visit of extension part of this study, the study doctor will check if each person can take part. Participants who can take part will receive an injection of TAK-019 as a second booster vaccination at the first visit of extension part.\n\nThe participants will stay in the main part of this study for up to 12 months after they have had their injection or up to the start of extension part. For participants who will take part in the extension part, they will stay in the extension part for up to 12 months from the start of extension part. During this time, the doctors will continue to collect blood samples to check immune response. Also, they will check if participants have any more side effects from TAK-019.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMAIN PART:\n\n1. Healthy Japanese male and female adult participants aged \\>= 20 years of age at the time of signing of informed consent.\n2. Participant who completed 2 doses primary vaccinations with another specified mRNA vaccine which is available in Japan 6 to 12 months prior to the trial vaccination.\n\n EXTENSION PART:\n3. Participants who received the first trial vaccination at least 5 months earlier and are currently enrolled in the Main Part (ie, not have withdrawn or discontinued early).\n\nExclusion Criteria:\n\nMAIN PART:\n\n1. Participants who received any other SARS-CoV-2 vaccine (except for the specified mRNA vaccine) or other experimental novel coronavirus vaccine prior to the trial.\n2. Participant who received a booster vaccination (i.e. 3rd dose)\n3. Participants who have close contact of anyone known to have COVID-19 within 14 days prior to the trial vaccination.\n4. Participants who were tested positive for SARS-CoV-2 prior to the trial.\n5. Participants who have traveled outside of Japan in the 30 days prior to the trial participation.\n6. Participants with a clinically significant active infection or oral temperature \\>= 38 degree Celsius within 3 days of the intended date of the first single booster vaccination.\n7. Participants with body mass index (BMI) greater than or equal to 30 kg/m\\^2 (BMI= weight in kg/ height in meters\\^2)\n\n EXTENSION PART:\n8. Participants with a clinically significant active infection or oral temperature \\>=38 degree Celsius within 3 days of the intended date of the second single booster vaccination.'}, 'identificationModule': {'nctId': 'NCT05299359', 'briefTitle': 'A Single Heterologous Booster Vaccination Study of TAK-019 in Healthy Japanese Adults (COVID-19)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 3, Single Arm, Open-Label Trial to Evaluate the Immunogenicity and Safety of a Single Heterologous Booster Vaccination of TAK-019 in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)', 'orgStudyIdInfo': {'id': 'TAK-019-3001'}, 'secondaryIdInfos': [{'id': 'jRCT2071210141', 'type': 'REGISTRY', 'domain': 'jRCT'}, {'id': 'U1111-1281-3948', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAK-019 Main Part', 'description': 'TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm', 'interventionNames': ['Biological: TAK-019']}, {'type': 'EXPERIMENTAL', 'label': 'TAK-019 Extension Part', 'description': 'TAK-019 0 .5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm. The participants who received the first single booster vaccination of TAK-019 in the main part and remained in study follow-up at least 5 months will receive a second single booster vaccination of TAK-019 by intramuscular injection.', 'interventionNames': ['Biological: TAK-019']}], 'interventions': [{'name': 'TAK-019', 'type': 'BIOLOGICAL', 'description': 'TAK-019 intramuscular injection', 'armGroupLabels': ['TAK-019 Extension Part', 'TAK-019 Main Part']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sumida-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Sumida Hospital'}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'PS Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}