Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-02-19 @ 9:30 AM
Study NCT ID:
NCT05160766
Status:
COMPLETED
Last Update Posted:
2025-05-20
First Post:
2021-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessing Immune Response of Different COVID-19 Vaccines in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ireland']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090982', 'term': 'BNT162 Vaccine'}, {'id': 'D000090983', 'term': '2019-nCoV Vaccine mRNA-1273'}], 'ancestors': [{'id': 'D000087503', 'term': 'mRNA Vaccines'}, {'id': 'D000087504', 'term': 'Nucleic Acid-Based Vaccines'}, {'id': 'D014614', 'term': 'Vaccines, Synthetic'}, {'id': 'D011994', 'term': 'Recombinant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000086663', 'term': 'COVID-19 Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'oliver.cornely@uk-koeln.de', 'phone': '0049 221 478 85523', 'title': 'Prof. Dr. med. Oliver A. Cornely', 'organization': 'University Hospital Cologne'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).', 'eventGroups': [{'id': 'EG000', 'title': 'BNT162b2 (Part A)', 'description': 'vaccination with BNT162b2 as 3rd vaccination\n\nComirnaty (BTN162b2): Single booster shot (3rd dose)', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 20, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'mRNA-1273 (Part A)', 'description': 'vaccination with mRNA-1273 as 3rd vaccination\n\nSpikevax (mRNA-1273): Single booster shot (3rd dose)', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 25, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BNT162b2 (Part B)', 'description': 'vaccination with BNT162b2 as 4th vaccination\n\nComirnaty (BTN162b2): Single booster shot (4th dose)', 'otherNumAtRisk': 135, 'deathsNumAtRisk': 135, 'otherNumAffected': 103, 'seriousNumAtRisk': 135, 'deathsNumAffected': 2, 'seriousNumAffected': 21}, {'id': 'EG003', 'title': 'mRNA-1273 (Part B)', 'description': 'vaccination with mRNA-1273 as 4th vaccination\n\nSpikevax (mRNA-1273): Single booster shot (4th dose)', 'otherNumAtRisk': 135, 'deathsNumAtRisk': 135, 'otherNumAffected': 110, 'seriousNumAtRisk': 135, 'deathsNumAffected': 5, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Anaemia megaloblastic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blindness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Eye oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Myopic chorioretinal degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Extensive swelling of vaccinated limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 35, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 57, 'numAffected': 51}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Injection site dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 55, 'numAffected': 54}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 62, 'numAffected': 59}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 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1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Plasmacytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Brain stem stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Obstructive sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vertebroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25}, {'groupId': 'EG001', 'numAtRisk': 27}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Antibody Titre Increase 14 Days After Study Vaccination Dose.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '133', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 (Part A)', 'description': 'vaccination with BNT162b2 as 3rd vaccination\n\nComirnaty (BTN162b2): Single booster shot (3rd dose)'}, {'id': 'OG001', 'title': 'mRNA-1273 (Part A)', 'description': 'vaccination with mRNA-1273 as 3rd vaccination\n\nSpikevax (mRNA-1273): Single booster shot (3rd dose)'}, {'id': 'OG002', 'title': 'BNT162b2 (Part B)', 'description': 'vaccination with BNT162b2 as 4th vaccination\n\nComirnaty (BTN162b2): Single booster shot (4th dose)'}, {'id': 'OG003', 'title': 'mRNA-1273 (Part B)', 'description': 'vaccination with mRNA-1273 as 4th vaccination\n\nSpikevax (mRNA-1273): Single booster shot (4th dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '83.9', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '100'}, {'value': '78.46', 'groupId': 'OG002', 'lowerLimit': '69.2', 'upperLimit': '86'}, {'value': '87.22', 'groupId': 'OG003', 'lowerLimit': '79.3', 'upperLimit': '93'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 0 until Day 14', 'description': 'Rate of 2-fold antibody titre increase 14 days after 3rd (Part A) or 4th vaccination dose (Part B) measured by qualitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wildtype virus.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All primary analyses were performed on the mITT population set. The primary endpoint was the rate π of 2-fold IgG antibody titre increase following a 3rd (Part A) or 4th dose vaccination (Part B) measured by quantitative enzyme-linked electrochemiluminescent immunoassay (Anti-RBD-ELISA) against wild-type virus at 14 days after study vaccination (versus immediately before vaccination).'}, {'type': 'SECONDARY', 'title': 'Change in Neutralizing Antibody Titre Against Wild-type 14 Days After Study Vaccination Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BTN162b2 (Part A)', 'description': 'vaccination with BNT162b2 as 3rd vaccination\n\nComirnaty (BTN162b2): Single booster shot (3rd dose)'}, {'id': 'OG001', 'title': 'mRNA-1273 (Part A)', 'description': 'vaccination with mRNA-1273 as 3rd vaccination\n\nSpikevax (mRNA-1273): Single booster shot (3rd dose)'}, {'id': 'OG002', 'title': 'BTN162b2 (Part B)', 'description': 'vaccination with BNT162b2 as 4th vaccination\n\nComirnaty (BTN162b2): Single booster shot (4th dose)'}, {'id': 'OG003', 'title': 'mRNA-1273 (Part B)', 'description': 'vaccination with mRNA-1273 as 4th vaccination\n\nSpikevax (mRNA-1273): Single booster shot (4th dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '58.49', 'spread': '16.25', 'groupId': 'OG000'}, {'value': '65.98', 'spread': '18.32', 'groupId': 'OG001'}, {'value': '37.33', 'spread': '22.93', 'groupId': 'OG002'}, {'value': '41.45', 'spread': '24.09', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.03143', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.557', 'ciLowerLimit': '1.168', 'ciUpperLimit': '23.946', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.661', 'groupDescription': 'The statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0101', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.331', 'ciLowerLimit': '1.04', 'ciUpperLimit': '7.621', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.671', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From Day 0 until Day 14', 'description': 'Change in neutralizing antibody titre (Virus Neutralisation Assay) against wild-type 14 days after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only.\n\nMicroneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients\' antibodies neutralizing capacities.', 'unitOfMeasure': 'percentage of inhibition', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects for whom the difference of neutralizing activity (Day 14 minus Day 0) could be calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Neutralizing Antibody Titre Against Variants of Concern 14 Days After Study Vaccination Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 (Part A)', 'description': 'vaccination with BNT162b2 as 3rd vaccination\n\nComirnaty (BTN162b2): Single booster shot (3rd dose)'}, {'id': 'OG001', 'title': 'mRNA-1273 (Part A)', 'description': 'vaccination with mRNA-1273 as 3rd vaccination\n\nSpikevax (mRNA-1273): Single booster shot (3rd dose)'}, {'id': 'OG002', 'title': 'BNT162b2 (Part B)', 'description': 'vaccination with BNT162b2 as 4th vaccination\n\nComirnaty (BTN162b2): Single booster shot (4th dose)'}, {'id': 'OG003', 'title': 'mRNA-1273 (Part B)', 'description': 'vaccination with mRNA-1273 as 4th vaccination\n\nSpikevax (mRNA-1273): Single booster shot (4th dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '49.86', 'spread': '17.62', 'groupId': 'OG000'}, {'value': '57.39', 'spread': '19.77', 'groupId': 'OG001'}, {'value': '38.17', 'spread': '21.74', 'groupId': 'OG002'}, {'value': '44.04', 'spread': '23.94', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.04405', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.168', 'ciLowerLimit': '0.338', 'ciUpperLimit': '23.998', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.88', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "B.1.1.7 (alpha)".'}, {'pValue': '0.01744', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.212', 'ciLowerLimit': '2.61', 'ciUpperLimit': '25.814', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.767', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "B.1.351 (beta)".'}, {'pValue': '0.02039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.239', 'ciLowerLimit': '2.305', 'ciUpperLimit': '26.173', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.932', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "P.1 (gamma)".'}, {'pValue': '0.04989', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.331', 'ciLowerLimit': '0.005', 'ciUpperLimit': '18.656', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.636', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.1 (omicron)".'}, {'pValue': '0.02259', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.312', 'ciLowerLimit': '1.514', 'ciUpperLimit': '19.111', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.373', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.4 (omicron)".'}, {'pValue': '0.01583', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.601', 'ciLowerLimit': '2.279', 'ciUpperLimit': '20.924', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.634', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.4.6 (omicron)".'}, {'pValue': '0.00856', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.863', 'ciLowerLimit': '3.166', 'ciUpperLimit': '20.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.323', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.5 (omicron)".'}, {'pValue': '0.00258', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.83', 'ciLowerLimit': '2.41', 'ciUpperLimit': '11.249', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.244', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "B.1.1.7 (alpha)".'}, {'pValue': '0.00748', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.048', 'ciLowerLimit': '1.63', 'ciUpperLimit': '10.466', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.244', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "B.1.351 (beta)".'}, {'pValue': '0.00922', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.302', 'ciLowerLimit': '1.821', 'ciUpperLimit': '12.782', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.782', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "P.1 (gamma)".'}, {'pValue': '0.07136', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.791', 'ciLowerLimit': '-0.419', 'ciUpperLimit': '10.001', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.646', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.1 (omicron)".'}, {'pValue': '0.07218', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.965', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '8.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.196', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.4 (omicron)".'}, {'pValue': '0.02949', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.82', 'ciLowerLimit': '0.484', 'ciUpperLimit': '9.155', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.202', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.4.6 (omicron)".'}, {'pValue': '0.08403', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.926', 'ciLowerLimit': '-0.531', 'ciUpperLimit': '8.382', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.263', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.5 (omicron)".'}], 'paramType': 'MEAN', 'timeFrame': 'From Day 0 until Day 14', 'description': 'Change in neutralizing antibody titre (Virus Neutralisation Assay) against variants of concern 14 days after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only.\n\nMicroneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients\' antibodies neutralizing capacities.', 'unitOfMeasure': 'percentage of inhibition', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Antibody Titre Level at 12 Months After a Study Vaccination Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BTN162b2 (Part A)', 'description': 'vaccination with BNT162b2 as 3rd vaccination\n\nComirnaty (BTN162b2): Single booster shot (3rd dose)'}, {'id': 'OG001', 'title': 'mRNA-1273 (Part A)', 'description': 'vaccination with mRNA-1273 as 3rd vaccination\n\nSpikevax (mRNA-1273): Single booster shot (3rd dose)'}, {'id': 'OG002', 'title': 'BNT162b2 (Part B)', 'description': 'vaccination with BNT162b2 as 4th vaccination\n\nComirnaty (BTN162b2): Single booster shot (4th dose)'}, {'id': 'OG003', 'title': 'mRNA-1273 (Part B)', 'description': 'vaccination with mRNA-1273 as 4th vaccination\n\nSpikevax (mRNA-1273): Single booster shot (4th dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '9319.7', 'spread': '25896.27', 'groupId': 'OG000'}, {'value': '14163.81', 'spread': '46209.35', 'groupId': 'OG001'}, {'value': '9961.92', 'spread': '26292.23', 'groupId': 'OG002'}, {'value': '12024.3', 'spread': '29129.18', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From Day 0 until Month 12', 'description': 'Antibody titre level at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B) measured by a quantitative enzyme-linked immunosorbent assay (anti-RBD-ELISA assay).', 'unitOfMeasure': 'IU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in whom a blood sampling was performed at Month 12.'}, {'type': 'SECONDARY', 'title': 'Neutralizing Antibody Titre Against Wild-type at 12 Months After Study Vaccination Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 (Part A)', 'description': 'vaccination with BNT162b2 as 3rd vaccination\n\nComirnaty (BTN162b2): Single booster shot (3rd dose)'}, {'id': 'OG001', 'title': 'mRNA-1273 (Part A)', 'description': 'vaccination with mRNA-1273 as 3rd vaccination\n\nSpikevax (mRNA-1273): Single booster shot (3rd dose)'}, {'id': 'OG002', 'title': 'BNT162b2 (Part B)', 'description': 'vaccination with BNT162b2 as 4th vaccination\n\nComirnaty (BTN162b2): Single booster shot (4th dose)'}, {'id': 'OG003', 'title': 'mRNA-1273 (Part B)', 'description': 'vaccination with mRNA-1273 as 4th vaccination\n\nSpikevax (mRNA-1273): Single booster shot (4th dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'spread': '33.64', 'groupId': 'OG000'}, {'value': '62.65', 'spread': '33.26', 'groupId': 'OG001'}, {'value': '12.93', 'spread': '39.29', 'groupId': 'OG002'}, {'value': '18.15', 'spread': '33.24', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 0 until Month 12', 'description': 'Neutralizing antibody titre (Virus Neutralisation Assay) against wild-type SARS-CoV-2 at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only.\n\nMicroneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients\' antibodies neutralizing capacities.', 'unitOfMeasure': 'percentage of inhibition', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Titres of neutralizing antibodies were reported as change in neutralization capacity.'}, {'type': 'SECONDARY', 'title': 'Neutralizing Antibody Titre Against Variants of Concern at 12 Months After Study Vaccination Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 (Part A)', 'description': 'vaccination with BNT162b2 as 3rd vaccination\n\nComirnaty (BTN162b2): Single booster shot (3rd dose)'}, {'id': 'OG001', 'title': 'mRNA-1273 (Part A)', 'description': 'vaccination with mRNA-1273 as 3rd vaccination\n\nSpikevax (mRNA-1273): Single booster shot (3rd dose)'}, {'id': 'OG002', 'title': 'BNT162b2 (Part B)', 'description': 'vaccination with BNT162b2 as 4th vaccination\n\nComirnaty (BTN162b2): Single booster shot (4th dose)'}, {'id': 'OG003', 'title': 'mRNA-1273 (Part B)', 'description': 'vaccination with mRNA-1273 as 4th vaccination\n\nSpikevax (mRNA-1273): Single booster shot (4th dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '40.59', 'spread': '35.37', 'groupId': 'OG000'}, {'value': '49', 'spread': '36.37', 'groupId': 'OG001'}, {'value': '15.76', 'spread': '38.4', 'groupId': 'OG002'}, {'value': '20.24', 'spread': '37.24', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.42797', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.835', 'ciLowerLimit': '-13.475', 'ciUpperLimit': '31.145', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.03', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "B.1.1.7 (alpha)".'}, {'pValue': '0.73961', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.54', 'ciLowerLimit': '-17.85', 'ciUpperLimit': '24.929', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.575', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "B.1.351 (beta)".'}, {'pValue': '0.45370', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.086', 'ciLowerLimit': '-13.524', 'ciUpperLimit': '29.695', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.683', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "P.1 (gamma)".'}, {'pValue': '0.87323', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.636', 'ciLowerLimit': '-18.969', 'ciUpperLimit': '22.241', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.187', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.1 (omicron)".'}, {'pValue': '0.93489', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '-19.109', 'ciUpperLimit': '20.728', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.848', 'groupDescription': 'This statistical analysis relfects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.4 (omicron)".'}, {'pValue': '0.74784', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.511', 'ciLowerLimit': '-18.425', 'ciUpperLimit': '25.448', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.845', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.4.6 (omicron)".'}, {'pValue': '0.84202', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.088', 'ciLowerLimit': '-18.966', 'ciUpperLimit': '23.143', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.409', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.5 (omicron)".'}, {'pValue': '0.15477', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.807', 'ciLowerLimit': '-2.207', 'ciUpperLimit': '13.821', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.068', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "B.1.1.7 (alpha)".'}, {'pValue': '0.37773', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.52', 'ciLowerLimit': '-4.327', 'ciUpperLimit': '11.368', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.984', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "B.1.351 (beta)".'}, {'pValue': '0.29212', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.413', 'ciLowerLimit': '-3.821', 'ciUpperLimit': '12.647', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.18', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "P.1 (gamma)".'}, {'pValue': '0.14140', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.961', 'ciLowerLimit': '-1.998', 'ciUpperLimit': '13.919', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.04', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.1 (omicron)".'}, {'pValue': '0.57090', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.199', 'ciLowerLimit': '-5.434', 'ciUpperLimit': '9.832', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.875', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.4 (omicron)".'}, {'pValue': '0.11012', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.528', 'ciLowerLimit': '-1.491', 'ciUpperLimit': '14.548', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.071', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.4.6 (omicron)".'}, {'pValue': '0.29755', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.239', 'ciLowerLimit': '-3.759', 'ciUpperLimit': '12.237', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.06', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.5 (omicron)".'}], 'paramType': 'MEAN', 'timeFrame': 'From Day 0 until Month 12', 'description': 'Neutralizing antibody titre (Virus Neutralisation Assay) against variants of concern at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only.\n\nMicroneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients\' antibodies neutralizing capacities.', 'unitOfMeasure': 'percentage of inhibition', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Titres of neutralizing antibodies were reported as change in neutralization capacity. Provided values refer to the variant "B.1.1.7 (alpha)". Besides for B.1.1.7 (alpha), all tests described above were also conducted for the following variants of concern: B.1.351 (beta), P.1 (gamma), BA.1 (omicron), BA.4 (omicron), BA.4.6 (omicron), and BA.5 (omicron).\n\nFor values of these variants of concern, please see the open-access publication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Unsolicited AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 (Part A)', 'description': 'vaccination with BNT162b2 as 3rd vaccination\n\nComirnaty (BTN162b2): Single booster shot (3rd dose)'}, {'id': 'OG001', 'title': 'mRNA-1273 (Part A)', 'description': 'vaccination with mRNA-1273 as 3rd vaccination\n\nSpikevax (mRNA-1273): Single booster shot (3rd dose)'}, {'id': 'OG002', 'title': 'BNT162b2 (Part B)', 'description': 'vaccination with BNT162b2 as 4th vaccination\n\nComirnaty (BTN162b2): Single booster shot (4th dose)'}, {'id': 'OG003', 'title': 'mRNA-1273 (Part B)', 'description': 'vaccination with mRNA-1273 as 4th vaccination\n\nSpikevax (mRNA-1273): Single booster shot (4th dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 until Month 12', 'description': 'Number of Participants with Unsolicited AEs until the end of trial', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Solicited AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 (Part A)', 'description': 'vaccination with BNT162b2 as 3rd vaccination\n\nComirnaty (BTN162b2): Single booster shot (3rd dose)'}, {'id': 'OG001', 'title': 'mRNA-1273 (Part A)', 'description': 'vaccination with mRNA-1273 as 3rd vaccination\n\nSpikevax (mRNA-1273): Single booster shot (3rd dose)'}, {'id': 'OG002', 'title': 'BNT162b2 (Part B)', 'description': 'vaccination with BNT162b2 as 4th vaccination\n\nComirnaty (BTN162b2): Single booster shot (4th dose)'}, {'id': 'OG003', 'title': 'mRNA-1273 (Part B)', 'description': 'vaccination with mRNA-1273 as 4th vaccination\n\nSpikevax (mRNA-1273): Single booster shot (4th dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 until Day 7', 'description': 'Number of Participants with Solicited AEs for 7 days after study vaccination dose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Rate of SAEs Grade ≥3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 (Part A)', 'description': 'vaccination with BNT162b2 as 3rd vaccination\n\nComirnaty (BTN162b2): Single booster shot (3rd dose)'}, {'id': 'OG001', 'title': 'mRNA-1273 (Part A)', 'description': 'vaccination with mRNA-1273 as 3rd vaccination\n\nSpikevax (mRNA-1273): Single booster shot (3rd dose)'}, {'id': 'OG002', 'title': 'BNT162b2 (Part B)', 'description': 'vaccination with BNT162b2 as 4th vaccination\n\nComirnaty (BTN162b2): Single booster shot (4th dose)'}, {'id': 'OG003', 'title': 'mRNA-1273 (Part B)', 'description': 'vaccination with mRNA-1273 as 4th vaccination\n\nSpikevax (mRNA-1273): Single booster shot (4th dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 until Month 3', 'description': 'Number of Participants with Rate of serious adverse events (SAEs) Grade ≥3 according to the National Cancer Institute Common Toxicity Criteria up to three months after study vaccination dose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Provided values refer to SAEs related to the IMP. All other trial data is available upon request.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Cellular Immune Response Measured by qPCR 14 Days After 4th Vaccination Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2', 'description': 'vaccination with BNT162b2 as 4th vaccination\n\nComirnaty(BTN162b2): Single booster shot (4th dose)'}, {'id': 'OG001', 'title': 'mRNA-1273', 'description': 'vaccination with mRNA-1273 as 4th vaccination\n\nSpikevax (mRNA-1273): Single booster shot (4th dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '26.63', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '26.63', 'spread': '1.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 0 until Day 14', 'description': 'Change in cellular immune response (CD4+ and CD8+ T cell response) to SARS-CoV-2 measured by fold change of CXCL10 mRNA levels measured by qPCR after 4th vaccination dose, to be determined in a subgroup only.', 'unitOfMeasure': 'Fold change of CXCL10 mRNA levels', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Inclusion required completed visits at Day 0 and Day 14 with a sufficient number of aliquots as per CTP.\n\nProvided results are absolute values of the cellular immune response on Day 14 of tubes stimulated with peptides from spike (tube A). Samples were also stimulated with peptides from a virus membrane nucleoprotein (tube B) and with peptides from the Omicron variant (tube C). All trial results will be provided upon request.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Neutralizing Antibody Titre Against Newly Emerging Variants in Bio-banked Samples After Study Vaccination Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 (Part A)', 'description': 'vaccination with BNT162b2 as 3rd vaccination\n\nComirnaty (BTN162b2): Single booster shot (3rd dose)'}, {'id': 'OG001', 'title': 'mRNA-1273 (Part A)', 'description': 'vaccination with mRNA-1273 as 3rd vaccination\n\nSpikevax (mRNA-1273): Single booster shot (3rd dose)'}, {'id': 'OG002', 'title': 'BNT162b2 (Part B)', 'description': 'vaccination with BNT162b2 as 4th vaccination\n\nComirnaty (BTN162b2): Single booster shot (4th dose)'}, {'id': 'OG003', 'title': 'mRNA-1273 (Part B)', 'description': 'vaccination with mRNA-1273 as 4th vaccination\n\nSpikevax (mRNA-1273): Single booster shot (4th dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '19.28', 'spread': '30.94', 'groupId': 'OG000'}, {'value': '27.18', 'spread': '28.14', 'groupId': 'OG001'}, {'value': '16.75', 'spread': '34.24', 'groupId': 'OG002'}, {'value': '19.03', 'spread': '33.01', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.39426', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.64', 'ciLowerLimit': '-12.995', 'ciUpperLimit': '32.275', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.191', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "P.2 (gamma)".'}, {'pValue': '0.42055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.764', 'ciLowerLimit': '-13.011', 'ciUpperLimit': '30.539', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.765', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "B.1.617".'}, {'pValue': '0.44391', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.472', 'ciLowerLimit': '-13.683', 'ciUpperLimit': '30.627', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.953', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "B.1.617.1 (kappa)".'}, {'pValue': '0.43775', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.483', 'ciLowerLimit': '-13.402', 'ciUpperLimit': '30.368', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.82', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "AY.3 (delta)".'}, {'pValue': '0.53511', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.19', 'ciLowerLimit': '-13.819', 'ciUpperLimit': '26.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.892', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "AY.4.2 (delta)".'}, {'pValue': '0.67576', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.552', 'ciLowerLimit': '-17.295', 'ciUpperLimit': '26.399', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.801', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "B.1.617.3".'}, {'pValue': '0.45443', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.438', 'ciLowerLimit': '-14.15', 'ciUpperLimit': '31.027', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.168', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "B.1.526.1 (iota)".'}, {'pValue': '0.38904', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.901', 'ciLowerLimit': '-11.768', 'ciUpperLimit': '29.569', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.218', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.2+L452M (omicron)".'}, {'pValue': '0.47466', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.302', 'ciLowerLimit': '-13.147', 'ciUpperLimit': '27.751', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.11', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.2+L452R (omicron)".'}, {'pValue': '0.77110', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.878', 'ciLowerLimit': '-16.993', 'ciUpperLimit': '22.749', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.824', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.2.12.1 (omicron)".'}, {'pValue': '0.86646', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.753', 'ciLowerLimit': '-19.195', 'ciUpperLimit': '22.701', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.2.75 (omicron)".'}, {'pValue': '0.57972', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.42', 'ciLowerLimit': '-14.21', 'ciUpperLimit': '25.049', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.705', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.2.75.2 (omicron)".'}, {'pValue': '0.90166', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '-17.859', 'ciUpperLimit': '20.199', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.408', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.3 (omicron)".'}, {'pValue': '0.92279', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.018', 'ciLowerLimit': '-20.099', 'ciUpperLimit': '22.136', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.44', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BF.7 (omicron)".'}, {'pValue': '0.71191', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.532', 'ciLowerLimit': '-15.675', 'ciUpperLimit': '22.74', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.496', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BQ.1 (omicron)".'}, {'pValue': '0.73415', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.995', 'ciLowerLimit': '-14.714', 'ciUpperLimit': '20.703', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.755', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BQ.1.1 (omicron)".'}, {'pValue': '0.45798', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.157', 'ciLowerLimit': '-12.155', 'ciUpperLimit': '26.469', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.548', 'groupDescription': 'This statistical analysis reflects Part A of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "XBB.1 (omicron)".'}, {'pValue': '0.23582', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.819', 'ciLowerLimit': '-3.169', 'ciUpperLimit': '12.808', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.055', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "P.2 (gamma)".'}, {'pValue': '0.19354', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.312', 'ciLowerLimit': '-2.713', 'ciUpperLimit': '13.337', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.074', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "B.1.617".'}, {'pValue': '0.17033', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.714', 'ciLowerLimit': '-2.471', 'ciUpperLimit': '13.899', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.155', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "B.1.617.1 (kappa)".'}, {'pValue': '0.13895', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.934', 'ciLowerLimit': '-1.94', 'ciUpperLimit': '13.808', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.997', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "AY.3 (delta)".'}, {'pValue': '0.26924', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.222', 'ciLowerLimit': '-3.288', 'ciUpperLimit': '11.732', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.812', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "AY.4.2 (delta)".'}, {'pValue': '0.17080', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.49', 'ciLowerLimit': '-2.382', 'ciUpperLimit': '13.362', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.996', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "B.1.617.3".'}, {'pValue': '0.18502', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.567', 'ciLowerLimit': '-2.683', 'ciUpperLimit': '13.818', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.188', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "B.1.526.1 (iota)".'}, {'pValue': '0.38344', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.438', 'ciLowerLimit': '-4.318', 'ciUpperLimit': '11.195', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.938', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.2+L452M (omicron)".'}, {'pValue': '0.41100', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.279', 'ciLowerLimit': '-4.565', 'ciUpperLimit': '11.124', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.982', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.2+L452R (omicron)".'}, {'pValue': '0.50660', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.67', 'ciLowerLimit': '-5.237', 'ciUpperLimit': '10.577', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.014', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.2.12.1 (omicron)".'}, {'pValue': '0.28604', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.535', 'ciLowerLimit': '-3.82', 'ciUpperLimit': '12.891', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.242', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.2.75 (omicron)".'}, {'pValue': '0.11715', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.259', 'ciLowerLimit': '-1.582', 'ciUpperLimit': '14.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.98', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.2.75.2 (omicron)".'}, {'pValue': '0.33567', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.818', 'ciLowerLimit': '-3.978', 'ciUpperLimit': '11.613', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.957', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BA.3 (omicron)".'}, {'pValue': '0.15232', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.775', 'ciLowerLimit': '-2.147', 'ciUpperLimit': '13.697', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.022', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BF.7 (omicron)".'}, {'pValue': '0.21234', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.808', 'ciLowerLimit': '-2.766', 'ciUpperLimit': '12.383', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.845', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BQ.1 (omicron)".'}, {'pValue': '0.22687', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.58', 'ciLowerLimit': '-2.866', 'ciUpperLimit': '12.026', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.78', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "BQ.1.1 (omicron)".'}, {'pValue': '0.38832', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of means in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.498', 'ciLowerLimit': '-4.475', 'ciUpperLimit': '11.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.047', 'groupDescription': 'This statistical analysis reflects Part B of the study.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The above provided values refer to the variant "XBB.1 (omicron)".'}], 'paramType': 'MEAN', 'timeFrame': 'From Day 0 until Month 12', 'description': '"Neutralizing antibody titre (Virus Neutralisation Assay)" against newly emerging variants in bio-banked samples after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only.\n\nMicroneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients\' antibodies neutralizing capacities.', 'unitOfMeasure': 'percentage of inhibition', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Titres of neutralizing antibodies were reported as change in neutralization capacity. Provided values refer to the VoI "XBB.1 (omicron)".'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BNT162b2 (Part A)', 'description': 'Part A:\n\nParticipants were pre-vaccinated with 2 vaccinations when entering the trial, as follows:\n\nBNT162b2 + BNT162b2 mRNA-1273 + mRNA-1273 ChAdOx-1-S + ChAdOx-1-S\n\nA 3rd dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).'}, {'id': 'FG001', 'title': 'mRNA-1273 (Part A)', 'description': 'Part A:\n\nParticipants were pre-vaccinated with 2 vaccinations when entering the trial, as follows:\n\nBNT162b2 + BNT162b2 mRNA-1273 + mRNA-1273 ChAdOx-1-S + ChAdOx-1-S\n\nA 3rd dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).'}, {'id': 'FG002', 'title': 'BTN162b2 (Part B)', 'description': 'Part B:\n\nParticipants were pre-vaccinated with 3 vaccinations when entering the trial, as follows:\n\nBNT162b2 + BNT162b2 + BNT162b2 BNT162b2 + BNT162b2 + mRNA-1273 mRNA-1273 + mRNA-1273 + mRNA-1273 mRNA-1273 + mRNA-1273 + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + mRNA-1273\n\nA 4th dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).'}, {'id': 'FG003', 'title': 'mRNA-1273 (Part B)', 'description': 'Part B:\n\nParticipants were pre-vaccinated with 3 vaccinations when entering the trial, as follows:\n\nBNT162b2 + BNT162b2 + BNT162b2 BNT162b2 + BNT162b2 + mRNA-1273 mRNA-1273 + mRNA-1273 + mRNA-1273 mRNA-1273 + mRNA-1273 + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + mRNA-1273\n\nA 4th dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '135'}, {'groupId': 'FG003', 'numSubjects': '135'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '126'}, {'groupId': 'FG003', 'numSubjects': '123'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COVID-19 infection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'travel time', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'No show', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Due to poor recruitment, Part A of the trial (3rd COVID-19 vaccination) was closed to further enrolment on 13 Jan 2022. Part B (4th COVID-19 vaccination) started on 21 Jan 2022.\n\nIn Part A, one randomised subject did not receive the allocated intervention (mRNA-1273) due to an acute onset of SARS-CoV-2 infection.\n\nBoth Part A and B belong to one trial and fall under one NCT number.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}, {'value': '322', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'BNT162b2 (Part A)', 'description': 'Part A:\n\nParticipants were pre-vaccinated with 2 vaccinations when entering the trial, as follows:\n\nBNT162b2 + BNT162b2 mRNA-1273 + mRNA-1273 ChAdOx-1-S + ChAdOx-1-S A 3rd dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).'}, {'id': 'BG001', 'title': 'mRNA-1273 (Part A)', 'description': 'Part A:\n\nParticipants were pre-vaccinated with 2 vaccinations when entering the trial, as follows:\n\nBNT162b2 + BNT162b2 mRNA-1273 + mRNA-1273 ChAdOx-1-S + ChAdOx-1-S A 3rd dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).'}, {'id': 'BG002', 'title': 'BNT162b2 (Part B)', 'description': 'Part B:\n\nParticipants were pre-vaccinated with 3 vaccinations when entering the trial, as follows:\n\nBNT162b2 + BNT162b2 + BNT162b2 BNT162b2 + BNT162b2 + mRNA-1273 mRNA-1273 + mRNA-1273 + mRNA-1273 mRNA-1273 + mRNA-1273 + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + mRNA-1273 A 4th dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).'}, {'id': 'BG003', 'title': 'mRNA-1273 (Part B)', 'description': 'Part B:\n\nParticipants were pre-vaccinated with 3 vaccinations when entering the trial, as follows:\n\nBNT162b2 + BNT162b2 + BNT162b2 BNT162b2 + BNT162b2 + mRNA-1273 mRNA-1273 + mRNA-1273 + mRNA-1273 mRNA-1273 + mRNA-1273 + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + mRNA-1273 A 4th dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}, {'value': '322', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000', 'lowerLimit': '75', 'upperLimit': '87'}, {'value': '78', 'groupId': 'BG001', 'lowerLimit': '75', 'upperLimit': '85'}, {'value': '79', 'groupId': 'BG002', 'lowerLimit': '75', 'upperLimit': '99'}, {'value': '79', 'groupId': 'BG003', 'lowerLimit': '75', 'upperLimit': '99'}, {'value': '79', 'groupId': 'BG004', 'lowerLimit': '75', 'upperLimit': '99'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}, {'value': '322', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '155', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '167', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}, {'value': '322', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000', 'lowerLimit': '155', 'upperLimit': '190'}, {'value': '174', 'groupId': 'BG001', 'lowerLimit': '149', 'upperLimit': '198'}, {'value': '169', 'groupId': 'BG002', 'lowerLimit': '143', 'upperLimit': '189'}, {'value': '169', 'groupId': 'BG003', 'lowerLimit': '145', 'upperLimit': '198'}, {'value': '169', 'groupId': 'BG004', 'lowerLimit': '143', 'upperLimit': '198'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}, {'value': '322', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000', 'lowerLimit': '53', 'upperLimit': '97'}, {'value': '73', 'groupId': 'BG001', 'lowerLimit': '51', 'upperLimit': '100'}, {'value': '72', 'groupId': 'BG002', 'lowerLimit': '41', 'upperLimit': '119'}, {'value': '75', 'groupId': 'BG003', 'lowerLimit': '41.7', 'upperLimit': '110'}, {'value': '74', 'groupId': 'BG004', 'lowerLimit': '41', 'upperLimit': '119'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}, {'value': '322', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '25.6', 'groupId': 'BG000', 'lowerLimit': '20.3', 'upperLimit': '32.8'}, {'value': '24.1', 'groupId': 'BG001', 'lowerLimit': '16.8', 'upperLimit': '32.6'}, {'value': '25.4', 'groupId': 'BG002', 'lowerLimit': '16.6', 'upperLimit': '40.2'}, {'value': '25.4', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '41.8'}, {'value': '25.4', 'groupId': 'BG004', 'lowerLimit': '16.6', 'upperLimit': '41.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Duration between 1st and 2nd vaccination in days', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}, {'value': '322', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '84'}, {'value': '42', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '111'}, {'value': '22', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '86'}, {'value': '22', 'groupId': 'BG003', 'lowerLimit': '16', 'upperLimit': '114'}, {'value': '22', 'groupId': 'BG004', 'lowerLimit': '16', 'upperLimit': '114'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}, {'title': 'Duration between 2nd and 3rd vaccination in days', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}, {'value': '322', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000', 'lowerLimit': '185', 'upperLimit': '255'}, {'value': '190', 'groupId': 'BG001', 'lowerLimit': '184', 'upperLimit': '273'}, {'value': '207', 'groupId': 'BG002', 'lowerLimit': '124', 'upperLimit': '303'}, {'value': '205', 'groupId': 'BG003', 'lowerLimit': '126', 'upperLimit': '313'}, {'value': '206.5', 'groupId': 'BG004', 'lowerLimit': '124', 'upperLimit': '313'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-27', 'size': 926903, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-09T09:25', 'hasProtocol': True}, {'date': '2022-12-02', 'size': 718604, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-09T09:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No blinding is foreseen in this trial.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomised controlled, adaptive, multicentre Phase II protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2. This trial foresees testing of different vaccines as a third (first booster, Part A) or fourth vaccine dose (second booster, Part B) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 and SARS-CoV-2 variants in the elderly.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2021-11-11', 'resultsFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2021-12-14', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-02', 'studyFirstPostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Unsolicited AEs', 'timeFrame': 'From Day 0 until Month 12', 'description': 'Number of Participants with Unsolicited AEs until the end of trial'}, {'measure': 'Number of Participants With Solicited AEs', 'timeFrame': 'From Day 0 until Day 7', 'description': 'Number of Participants with Solicited AEs for 7 days after study vaccination dose.'}, {'measure': 'Number of Participants With Rate of SAEs Grade ≥3', 'timeFrame': 'From Day 0 until Month 3', 'description': 'Number of Participants with Rate of serious adverse events (SAEs) Grade ≥3 according to the National Cancer Institute Common Toxicity Criteria up to three months after study vaccination dose.'}, {'measure': 'Change in Cellular Immune Response Measured by qPCR 14 Days After 4th Vaccination Dose', 'timeFrame': 'From Day 0 until Day 14', 'description': 'Change in cellular immune response (CD4+ and CD8+ T cell response) to SARS-CoV-2 measured by fold change of CXCL10 mRNA levels measured by qPCR after 4th vaccination dose, to be determined in a subgroup only.'}, {'measure': 'Neutralizing Antibody Titre Against Newly Emerging Variants in Bio-banked Samples After Study Vaccination Dose', 'timeFrame': 'From Day 0 until Month 12', 'description': '"Neutralizing antibody titre (Virus Neutralisation Assay)" against newly emerging variants in bio-banked samples after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only.\n\nMicroneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients\' antibodies neutralizing capacities.'}], 'primaryOutcomes': [{'measure': 'Antibody Titre Increase 14 Days After Study Vaccination Dose.', 'timeFrame': 'From Day 0 until Day 14', 'description': 'Rate of 2-fold antibody titre increase 14 days after 3rd (Part A) or 4th vaccination dose (Part B) measured by qualitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wildtype virus.'}], 'secondaryOutcomes': [{'measure': 'Change in Neutralizing Antibody Titre Against Wild-type 14 Days After Study Vaccination Dose', 'timeFrame': 'From Day 0 until Day 14', 'description': 'Change in neutralizing antibody titre (Virus Neutralisation Assay) against wild-type 14 days after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only.\n\nMicroneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients\' antibodies neutralizing capacities.'}, {'measure': 'Change in Neutralizing Antibody Titre Against Variants of Concern 14 Days After Study Vaccination Dose', 'timeFrame': 'From Day 0 until Day 14', 'description': 'Change in neutralizing antibody titre (Virus Neutralisation Assay) against variants of concern 14 days after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only.\n\nMicroneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients\' antibodies neutralizing capacities.'}, {'measure': 'Antibody Titre Level at 12 Months After a Study Vaccination Dose', 'timeFrame': 'From Day 0 until Month 12', 'description': 'Antibody titre level at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B) measured by a quantitative enzyme-linked immunosorbent assay (anti-RBD-ELISA assay).'}, {'measure': 'Neutralizing Antibody Titre Against Wild-type at 12 Months After Study Vaccination Dose', 'timeFrame': 'From Day 0 until Month 12', 'description': 'Neutralizing antibody titre (Virus Neutralisation Assay) against wild-type SARS-CoV-2 at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only.\n\nMicroneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients\' antibodies neutralizing capacities.'}, {'measure': 'Neutralizing Antibody Titre Against Variants of Concern at 12 Months After Study Vaccination Dose', 'timeFrame': 'From Day 0 until Month 12', 'description': 'Neutralizing antibody titre (Virus Neutralisation Assay) against variants of concern at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only.\n\nMicroneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients\' antibodies neutralizing capacities.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'COVID-19', 'Vaccination', 'Immunogenicity', 'BNT162b2', 'mRNA-1273', 'Booster', 'Elderly', 'head-to-head comparison'], 'conditions': ['Prevention of COVID-19']}, 'referencesModule': {'references': [{'pmid': '36209129', 'type': 'DERIVED', 'citation': 'Neuhann JM, Stemler J, Carcas A, Frias-Iniesta J, Bethe U, Heringer S, Tischmann L, Zarrouk M, Cuppers A, Konig F, Posch M, Cornely OA. A multinational, phase 2, randomised, adaptive protocol to evaluate immunogenicity and reactogenicity of different COVID-19 vaccines in adults >/=75 already vaccinated against SARS-CoV-2 (EU-COVAT-1-AGED): a trial conducted within the VACCELERATE network. Trials. 2022 Oct 8;23(1):865. doi: 10.1186/s13063-022-06791-y.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomised controlled, adaptive, multicentre Phase II protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2.\n\nPart A of this trial foresees testing of different vaccines as a 3rd vaccination dose (first booster) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 wild-type and variants in the elderly, a usually neglected population.\n\nPart B of this trial foresees testing of different vaccines as a 4th vaccination dose (second booster) for comparative assessment of their immunogenicity and safety against SARSCoV-2 wild-type and variants in the identical population.', 'detailedDescription': 'Part A of the present trial in which individuals received a 3rd vaccination (first booster) of either BNT162b2 or mRNA-1273 was closed to further recruitment as of January 13, 2022. This was due to a change in vaccination policies, recommending a 3rd vaccination with either BNT162b2 or mRNA-1273. Therefore, Part A was supplanted by Part B that investigated a 4th COVID-19 vaccination and started on 21 Jan 2022.\n\nThe initial study protocol started the trial with Part A in which participants were randomized to a 3rd vaccination (first booster) with either BNT162b2 or mRNA-1273:\n\nSubjects who - prior to study entry - received a vaccination series of either BNT162b2 \\& BNT162b2 or mRNA-1273 \\& mRNA-1273 or ChAdOx-1-S \\& ChAdOx-1-S.\n\nFor the reasons mentioned above, the study protocol was amended to continue the trial with Part B in which participants were randomized to a 4th vaccination (second booster) with either BNT162b2 or mRNA-1273:\n\nSubjects who - prior to study entry - received a vaccination series of either BNT162b2 \\& BNT162b2 \\& BNT162b2 or BNT162b2 \\& BNT162b2 \\& mRNA-1273 or mRNA-1273 \\& mRNA-1273 \\& mRNA-1273 or mRNA-1273 \\& mRNA-1273 \\& BNT162b2 or ChAdOx-1-S \\& ChAdOx-1-S \\& BNT162b2 or ChAdOx-1-S \\& ChAdOx-1-S \\& mRNA-1273.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (Part A):\n\n* Subject is ≥75 years old.\n* Prior to study entry the subject was vaccinated with BNT162b2, mRNA-1273 or ChAdOx-1-S (same vaccine product for 1st + 2nd dose)\n\nBNT162b2 + BNT162b2\n\nmRNA-1273 + mRNA-1273\n\nChAdOx-1-S + ChAdOx-1-S\n\n* 9 ± 3 months since the second vaccine dose at time of enrolment for the planned 3rd vaccine dose in the trial. Vaccination status should be documented in the source data and captured in the eCRF.\n* No contra-indication against any of the vaccine products in the trial.\n* Written informed consent from subject has been obtained.\n\nExclusion Criteria (Part A):\n\n* Primary vaccination performed with different vaccine products as sole (e.g., COVID-19 Vaccine Janssen) or, 1st and 2nd vaccination doses (heterologous vaccination scheme).\n* Subjects with any significant or uncontrolled disease posing a risk due to vaccination as judged by the investigator.\n* Current immunosuppressive therapy, for example continuous glucocorticosteroid treatment equivalent to \\>10 mg/day prednisolone.\n* Participation in other interventional trials.\n* Subjects unable to report solicited adverse events.\n* Subject with any contraindications to the vaccines in the trial at randomisation. A list of contraindications as listed in the Summary of medicinal Product Characteristics (SmPC, the Fachinformation in Germany), if appropriate.\n* Use of drugs with significant interaction with the investigational product according to the SmPC or similar documents.\n* Diseases or findings that may have a significant effect on the target variables and which may therefore mask or inhibit the therapeutic effect under investigation.\n* Any current SARS-CoV-2 infection or proven in the preceding 3 months.\n* Persons with any kind of dependency on the principal investigator or employed by the sponsor or principal investigator.\n* Legally incapacitated persons.\n* Persons held in an institution by legal or official order.\n\nInclusion Criteria (Part B):\n\n* Subject is ≥75 years old.\n* Prior to study entry the subject was vaccinated with one of the following vaccination regimens (1st + 2nd + 3rd dose):\n\nBNT162b2 + BNT162b2 + BNT162b2\n\nBNT162b2 + BNT162b2 + mRNA-1273\n\nmRNA-1273 + mRNA-1273 + mRNA-1273\n\nmRNA-1273 + mRNA-1273 + BNT162b2\n\nChAdOx-1-S + ChAdOx-1-S + BNT162b2\n\nChAdOx-1-S + ChAdOx-1-S + mRNA-1273\n\nThe last dose of the above listed vaccinations must have been administered at least 1 month prior to study entry. Vaccination status should be documented in the source data and will be captured in the eCRF.\n\n\\- Written informed consent from subject has been obtained.\n\nExclusion Criteria (Part B):\n\n* Prior to study entry the subject got vaccinated with a regimen not included in the list given above.\n* Last anti-SARS-CoV-2 vaccine dose administered less than one month prior to study entry.\n* Vaccination against a disease other than COVID-19 within 2 weeks prior to study entry. Only exception: Influenza vaccination which is allowed at any time.\n* Subjects with any significant or uncontrolled disease posing a risk due to vaccination as judged by the investigator.\n* Current immunosuppressive therapy, for example continuous glucocorticosteroid treatment equivalent to \\>10 mg/day prednisolone.\n* Subject simultaneously participates in another clinical trials or has participated in the past 30 days.\n* Subjects unable to report solicited adverse events.\n* Subject with any contraindications to the vaccines in the trial. A list of contraindications as listed in the Summary of medicinal Product Characteristics (SmPC, the Fachinformation in Germany), if appropriate.'}, 'identificationModule': {'nctId': 'NCT05160766', 'acronym': 'EU-COVAT-1', 'briefTitle': 'Assessing Immune Response of Different COVID-19 Vaccines in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'A Multinational, Phase 2, Randomised, Adaptive Protocol to Evaluate Immunogenicity and Reactogenicity of Different COVID-19 Vaccines Administration in Older Adults (≥75) Already Vaccinated Against SARS-COV-2 (EU-COVAT-1_AGED)', 'orgStudyIdInfo': {'id': 'EU-COVAT-1_AGED'}, 'secondaryIdInfos': [{'id': '2021-004526-29', 'type': 'EUDRACT_NUMBER'}, {'id': 'uni-koeln-4602', 'type': 'OTHER', 'domain': 'University of Cologne'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BNT162b2 (Part A)', 'description': 'vaccination with BNT162b2 as 3rd vaccination', 'interventionNames': ['Biological: Comirnaty (BTN162b2)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'mRNA-1273 (Part A)', 'description': 'vaccination with mRNA-1273 as 3rd vaccination', 'interventionNames': ['Biological: Spikevax (mRNA-1273)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BNT162b2 (Part B)', 'description': 'vaccination with BNT162b2 as 4th vaccination', 'interventionNames': ['Biological: Comirnaty (BTN162b2)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'mRNA-1273 (Part B)', 'description': 'vaccination with mRNA-1273 as 4th vaccination', 'interventionNames': ['Biological: Spikevax (mRNA-1273)']}], 'interventions': [{'name': 'Comirnaty (BTN162b2)', 'type': 'BIOLOGICAL', 'description': 'Single booster shot (3rd dose in Part A and 4th dose in Part B)', 'armGroupLabels': ['BNT162b2 (Part A)', 'BNT162b2 (Part B)']}, {'name': 'Spikevax (mRNA-1273)', 'type': 'BIOLOGICAL', 'description': 'Single booster shot (3rd dose in Part A and 4th dose in Part B)', 'armGroupLabels': ['mRNA-1273 (Part A)', 'mRNA-1273 (Part B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50931', 'city': 'Cologne', 'country': 'Germany', 'facility': 'University Hospital Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'University Hospital Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Hannover Medical School Hospital', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '08661', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Vilnius University Hospital Santaros Klinikos', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Helse Bergen HF, Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '08916', 'city': 'Badalona', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Reina Sofia University Hospital', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'La Paz University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '20014', 'city': 'San Sebastián', 'country': 'Spain', 'facility': 'Biodonostia Health Research Institute', 'geoPoint': {'lat': 43.56667, 'lon': -5.9}}], 'overallOfficials': [{'name': 'Oliver A Cornely, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cologne'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Making de-identified/anonymized data accessible is currently under way. We expect to grant access through a central independent data repository no later than January 2025. Any pertinent information will be updated in due course.', 'ipdSharing': 'YES', 'description': 'Making de-identified/anonymized data accessible is currently under way. We expect to grant access through a central independent data repository no later than January 2025. Any pertinent information will be updated in due course.', 'accessCriteria': 'To be announced.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oliver Cornely, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'VACCELERATE', 'class': 'UNKNOWN'}, {'name': 'European Commission', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Coordinating Investigator', 'investigatorFullName': 'Oliver Cornely, MD', 'investigatorAffiliation': 'University of Cologne'}}}}