Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2026-03-06 @ 8:54 AM
Study NCT ID:
NCT05921903
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2023-06-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 4 (Visit 3 + 30-42 days).', 'description': 'Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.', 'eventGroups': [{'id': 'EG000', 'title': 'RSV_IC_1 Group', 'description': 'Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).', 'otherNumAtRisk': 131, 'deathsNumAtRisk': 131, 'otherNumAffected': 106, 'seriousNumAtRisk': 131, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'RSV_IC_2 Group', 'description': 'IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 120, 'seriousNumAtRisk': 130, 'deathsNumAffected': 2, 'seriousNumAffected': 18}, {'id': 'EG002', 'title': 'RSV_HA Group', 'description': 'Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 111, 'seriousNumAtRisk': 125, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Lymph gland infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Enterococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Herpes simplex reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Pneumonia pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Stenotrophomonas maltophilia pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Oesophageal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Paranasal sinus discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'MedDRA v27.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Administration site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 95, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 173, 'numAffected': 108}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 96, 'numAffected': 95}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Axillary pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 41, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 92, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 49, 'numAffected': 49}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Vaccination site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Myelodysplastic syndrome with excess blasts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 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'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 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{'term': 'Eyelid ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numEvents': 0, 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Only participants with data available at the specified timepoints were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV_IC_1 Group', 'description': 'Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'OG001', 'title': 'RSV_IC_2 Group', 'description': 'IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).'}, {'id': 'OG002', 'title': 'RSV_HA Group', 'description': 'Healthy participants received 1 dose of RSVPreF3 OA 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'lowerLimit': '4907.6', 'upperLimit': '9193.0'}]}]}, {'title': 'RSV-A , Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3990.8', 'groupId': 'OG000', 'lowerLimit': '3219.4', 'upperLimit': '4947.0'}, {'value': '4174.0', 'groupId': 'OG001', 'lowerLimit': '3230.7', 'upperLimit': '5392.6'}, {'value': '6822.5', 'groupId': 'OG002', 'lowerLimit': '5926.2', 'upperLimit': '7854.4'}]}]}, {'title': 'RSV-A , Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4184.7', 'groupId': 'OG000', 'lowerLimit': '3360.1', 'upperLimit': '5211.7'}, {'value': '5377.9', 'groupId': 'OG001', 'lowerLimit': '4265.4', 'upperLimit': '6780.6'}, {'value': '5707.0', 'groupId': 'OG002', 'lowerLimit': '4853.6', 'upperLimit': '6710.3'}]}]}, {'title': 'RSV-B, Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '864.2', 'groupId': 'OG000', 'lowerLimit': '727.8', 'upperLimit': '1026.2'}, {'value': '892.9', 'groupId': 'OG001', 'lowerLimit': '754.1', 'upperLimit': '1057.3'}, {'value': '1027.3', 'groupId': 'OG002', 'lowerLimit': '889.6', 'upperLimit': '1186.3'}]}]}, {'title': 'RSV-B, Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2325.3', 'groupId': 'OG000', 'lowerLimit': '1592.9', 'upperLimit': '3394.5'}, {'value': '2603.1', 'groupId': 'OG001', 'lowerLimit': '1714.9', 'upperLimit': '3951.3'}, {'value': '8113.6', 'groupId': 'OG002', 'lowerLimit': '5699.9', 'upperLimit': '11549.5'}]}]}, {'title': 'RSV-B, Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5002.9', 'groupId': 'OG000', 'lowerLimit': '3901.7', 'upperLimit': '6414.8'}, {'value': '4834.7', 'groupId': 'OG001', 'lowerLimit': '3736.6', 'upperLimit': '6255.6'}, {'value': '9140.5', 'groupId': 'OG002', 'lowerLimit': '7805.3', 'upperLimit': '10704.1'}]}]}, {'title': 'RSV-B, Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4461.7', 'groupId': 'OG000', 'lowerLimit': '3519.0', 'upperLimit': '5657.0'}, {'value': '5820.8', 'groupId': 'OG001', 'lowerLimit': '4658.2', 'upperLimit': '7273.5'}, {'value': '6281.6', 'groupId': 'OG002', 'lowerLimit': 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Only participants with data available at the specified timepoints were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'RSV-A and RSV-B Serum Neutralizing Titers Expressed as GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups', 'timeFrame': 'At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)', 'description': 'Neutralizing titers were calculated as GMT and expressed in titers (ED60).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV_HA Group', 'description': 'Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'OG001', 'title': 'Pooled RSV_IC Group', 'description': 'IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\\_IC\\_1 and RSV\\_IC\\_2 groups were pooled, as pre-specified in the statistical analysis plan for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).'}], 'classes': [{'title': 'Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6689.9', 'groupId': 'OG000', 'lowerLimit': '4639.3', 'upperLimit': '9646.7'}, {'value': '1902.8', 'groupId': 'OG001', 'lowerLimit': '1479.6', 'upperLimit': '2446.9'}]}]}, {'title': 'Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6653.8', 'groupId': 'OG000', 'lowerLimit': '5503.5', 'upperLimit': '8044.6'}, {'value': '4113.0', 'groupId': 'OG001', 'lowerLimit': '3595.5', 'upperLimit': '4705.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.52', 'ciLowerLimit': '2.26', 'ciUpperLimit': '5.48', 'estimateComment': 'The comparison is done using the group ratio of adjusted GMT (RSV\\_HA/Pooled RSV\\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.', 'groupDescription': 'To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\\_IC group) and healthy participants (RSV\\_HA group) for the RSV-A strain at Visit 2.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '1.28', 'ciUpperLimit': '2.04', 'estimateComment': 'The comparison is done using the group ratio of adjusted GMT (RSV\\_HA/Pooled RSV\\_IC) (ANCOVA model applied to the log10- transformed titers). 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The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\\_HA and Pooled RSV\\_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan.', 'unitOfMeasure': 'Titers (ED60)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral immunogenicity. 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The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\\_IC\\_1 and RSV\\_IC\\_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan.', 'unitOfMeasure': 'Titers (ED60)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral immunogenicity. 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The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\\_IC\\_2 and RSV\\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.', 'unitOfMeasure': 'Titers (ED60)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'RSV-A Serum Neutralizing Titers Expressed as Group GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups', 'timeFrame': 'At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV_HA Group', 'description': 'Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'OG001', 'title': 'Pooled RSV_IC Group', 'description': 'IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\\_IC\\_1 and RSV\\_IC\\_2 groups were pooled, as pre-specified in the statistical analysis plan for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).'}], 'classes': [{'title': 'Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8238.7', 'groupId': 'OG000', 'lowerLimit': '5972.9', 'upperLimit': '11364.1'}, {'value': '2442.6', 'groupId': 'OG001', 'lowerLimit': '1958.3', 'upperLimit': '3046.7'}]}]}, {'title': 'Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8545.5', 'groupId': 'OG000', 'lowerLimit': '7031.3', 'upperLimit': '10385.8'}, {'value': '5106.9', 'groupId': 'OG001', 'lowerLimit': '4448.4', 'upperLimit': '5863.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.37', 'ciLowerLimit': '2.28', 'ciUpperLimit': '4.98', 'estimateComment': 'The comparison is done using the group ratio of adjusted GMT (RSV\\_HA/Pooled RSV\\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.', 'groupDescription': 'To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\\_IC group) and healthy participants (RSV\\_HA group) for the RSV-B strain at Visit 2.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.67', 'ciLowerLimit': '1.32', 'ciUpperLimit': '2.13', 'estimateComment': 'The comparison is done using the group ratio of adjusted GMT (RSV\\_HA/Pooled RSV\\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.', 'groupDescription': 'To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\\_IC group) and healthy participants (RSV\\_HA group) for the RSV-B strain at Visit 3.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)', 'description': 'Group GMT was assessed for RSV\\_HA group over pooled RSV\\_IC group (combined RSV\\_IC\\_1 and RSV\\_IC\\_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\\_HA and Pooled RSV\\_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan.', 'unitOfMeasure': 'Titers (ED60)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV_IC_1 Group', 'description': 'Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'OG001', 'title': 'RSV_IC_2 Group', 'description': 'IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '4333.3', 'groupId': 'OG000', 'lowerLimit': '3510.0', 'upperLimit': '5349.8'}, {'value': '5550.5', 'groupId': 'OG001', 'lowerLimit': '4478.3', 'upperLimit': '6879.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.70', 'estimateComment': 'The comparison is done using the group ratio of adjusted GMT (RSV\\_IC\\_2/RSV\\_IC\\_1) (ANCOVA model applied to the log10- transformed titers). ANCOVA model included the group as fixed effect, and SOT type and baseline log10-transformed titer as covariate.', 'groupDescription': 'To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of vaccine (RSV\\_IC\\_1 group) and participants that received lung or kidney solid organ transplant and 2 doses of vaccine (RSV\\_IC\\_2 group) for the RSV-B strain at Visit 4.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)', 'description': 'Group GMT ratio of RSV\\_IC\\_2 over RSV\\_IC\\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\\_IC\\_1 and RSV\\_IC\\_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan.', 'unitOfMeasure': 'Titers (ED60)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV_IC_1 Group', 'description': 'Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'OG001', 'title': 'RSV_HA Group', 'description': 'Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '4632.9', 'groupId': 'OG000', 'lowerLimit': '3890.8', 'upperLimit': '5516.6'}, {'value': '5973.5', 'groupId': 'OG001', 'lowerLimit': '5000.9', 'upperLimit': '7135.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.65', 'estimateComment': 'The comparison is done using the group ratio of adjusted GMT (RSV\\_HA/RSV\\_IC\\_1) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.', 'groupDescription': 'To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of study intervention (RSV\\_IC\\_1 group) and healthy participants (RSV\\_HA group) for the RSV-B strain at Visit 4.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)', 'description': 'Group GMT of RSV\\_HA over RSV\\_IC\\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\\_IC\\_1 and RSV\\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.', 'unitOfMeasure': 'Titers (ED60)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV_IC_2 Group', 'description': 'IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).'}, {'id': 'OG001', 'title': 'RSV_HA Group', 'description': 'Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '6090.6', 'groupId': 'OG000', 'lowerLimit': '5184.6', 'upperLimit': '7155.0'}, {'value': '6123.0', 'groupId': 'OG001', 'lowerLimit': '5212.1', 'upperLimit': '7193.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.26', 'estimateComment': 'The comparison is done using the group ratio of adjusted GMT (RSV\\_HA/RSV\\_IC\\_2) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.', 'groupDescription': 'To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 2 doses of study intervention (RSV\\_IC\\_2 group) and healthy participants (RSV\\_HA group) for the RSV-B strain at Visit 4.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)', 'description': 'Group GMT of RSV\\_HA over RSV\\_IC\\_2 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\\_IC\\_2 and RSV\\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.', 'unitOfMeasure': 'Titers (ED60)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'RSV-B Serum Neutralizing Titers Expressed as Group GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups', 'timeFrame': 'At Visit 5 (last dose +180-210 days) and Visit 6 (last dose + 350-380 days)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '235', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV_IC_1 Group', 'description': 'Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'OG001', 'title': 'RSV_IC_2 Group', 'description': 'IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).'}, {'id': 'OG002', 'title': 'RSV_HA Group', 'description': 'Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'OG003', 'title': 'Pooled RSV_IC Group', 'description': 'IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\\_IC\\_1 and RSV\\_IC\\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).'}], 'classes': [{'title': 'RSV-A, Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.14', 'groupId': 'OG000', 'lowerLimit': '1.44', 'upperLimit': '3.18'}, {'value': '2.20', 'groupId': 'OG001', 'lowerLimit': '1.45', 'upperLimit': '3.34'}, {'value': '7.59', 'groupId': 'OG002', 'lowerLimit': '5.44', 'upperLimit': '10.58'}, {'value': '2.17', 'groupId': 'OG003', 'lowerLimit': '1.64', 'upperLimit': '2.87'}]}]}, {'title': 'RSV-A, Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '235', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.92', 'groupId': 'OG000', 'lowerLimit': '3.95', 'upperLimit': '6.12'}, {'value': '5.01', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '6.27'}, {'value': '7.82', 'groupId': 'OG002', 'lowerLimit': '6.74', 'upperLimit': '9.06'}, {'value': '4.96', 'groupId': 'OG003', 'lowerLimit': '4.24', 'upperLimit': '5.80'}]}]}, {'title': 'RSV-A, Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.29', 'groupId': 'OG000', 'lowerLimit': '4.24', 'upperLimit': '6.60'}, {'value': '6.53', 'groupId': 'OG001', 'lowerLimit': '5.32', 'upperLimit': '8.01'}, {'value': '6.55', 'groupId': 'OG002', 'lowerLimit': '5.60', 'upperLimit': '7.6'}]}]}, {'title': 'RSV-B, Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.51', 'groupId': 'OG000', 'lowerLimit': '1.78', 'upperLimit': '3.55'}, {'value': '2.54', 'groupId': 'OG001', 'lowerLimit': '1.75', 'upperLimit': '3.67'}, {'value': '8.59', 'groupId': 'OG002', 'lowerLimit': '6.59', 'upperLimit': '11.20'}, {'value': '2.53', 'groupId': 'OG003', 'lowerLimit': '1.98', 'upperLimit': '3.23'}]}]}, {'title': 'RSV-B, Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '235', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.72', 'groupId': 'OG000', 'lowerLimit': '4.53', 'upperLimit': '7.21'}, {'value': '5.34', 'groupId': 'OG001', 'lowerLimit': '4.25', 'upperLimit': '6.72'}, {'value': '8.80', 'groupId': 'OG002', 'lowerLimit': '7.67', 'upperLimit': '10.11'}, {'value': '5.53', 'groupId': 'OG003', 'lowerLimit': '4.71', 'upperLimit': '6.51'}]}]}, {'title': 'RSV-B, Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.22', 'groupId': 'OG000', 'lowerLimit': '4.20', 'upperLimit': '6.49'}, {'value': '6.52', 'groupId': 'OG001', 'lowerLimit': '5.34', 'upperLimit': '7.97'}, {'value': '6.35', 'groupId': 'OG002', 'lowerLimit': '5.50', 'upperLimit': '7.33'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days), each compared to Visit 1 (Day 1)', 'description': 'MGI was assessed at Visit 2 (in a subset of participants) over Visit 1 and Visit 3 over Visit 1 in RSV\\_HA and pooled RSV\\_IC (combined RSV\\_IC\\_1 and RSV\\_IC\\_2 groups), and at Visit 4 over Visit 1 in RSV\\_IC\\_1, RSV\\_IC\\_2, RSV\\_HA groups.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'RSV-A and RSV-B Serum Neutralizing Titers Expressed as MGI', 'timeFrame': 'At Visit 5 (last dose +180-210 days) and Visit 6 (last dose + 350-380 days), each compared with Visit 1 (Day 1)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV_IC_1 Group', 'description': 'Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'OG001', 'title': 'RSV_IC_2 Group', 'description': 'IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).'}, {'id': 'OG002', 'title': 'RSV_HA Group', 'description': 'Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}], 'classes': [{'title': 'Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '86.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '110.3', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '107.8', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2932.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3704.3', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '2959.8', 'spread': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1049.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1718.5', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '1042.4', 'spread': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '910.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2709.0', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '734.4', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days)', 'description': 'CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific cluster of differentiation CD4+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV\\_IC\\_1 and RSV\\_IC\\_2 groups) and healthy participants (from RSV\\_HA group).', 'unitOfMeasure': 'Specific CD4+ Tcells/million CD4+ Tcells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PPS for cell mediated immunity (CMI), which included all participants who received the study intervention administration as per protocol, had cell mediated immunogenicity results pre and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity, without prohibited concomitant medication/vaccination. Only participants with data available for CD4+ T cells at the specified timepoints were included in analysis.'}, {'type': 'SECONDARY', 'title': 'CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV_IC_1 Group', 'description': 'Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'OG001', 'title': 'RSV_IC_2 Group', 'description': 'IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).'}, {'id': 'OG002', 'title': 'RSV_HA Group', 'description': 'Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}], 'classes': [{'title': 'Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.9', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '27.7', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '13.0', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '22.3', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '21.0', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '16.9', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '13.2', 'spread': '1.1', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days)', 'description': 'CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV\\_IC\\_1 and RSV\\_IC\\_2 groups) and healthy participants (from RSV\\_HA group).', 'unitOfMeasure': 'Specific CD8+ Tcells/million CD8+ Tcells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for CMI. Only participants with data available for CD8+ T cells for the specified groups at the specified timepoints were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'CMI Response in a Subset of Participants', 'timeFrame': 'At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number Of Participants Reporting Any Solicited Administration Site Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV_IC_1 Group', 'description': 'Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'OG001', 'title': 'RSV_IC_2 Group', 'description': 'IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).'}, {'id': 'OG002', 'title': 'RSV_HA Group', 'description': 'Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}], 'classes': [{'title': 'Pain, Dosing at visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}]}, {'title': 'Pain, Dosing at visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'Erythema, Dosing at visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Erythema, Dosing at visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Swelling, Dosing at visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Swelling, Dosing at visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)', 'description': 'Assessed solicited administration site events included pain, erythema (redness) and swelling, at the injection site. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Exposed set (ES) which included all participants who received the study intervention administration. Only participants with solicited administration site events at the specified timepoints were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number Of Participants Reporting Any Solicited Systemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV_IC_1 Group', 'description': 'Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'OG001', 'title': 'RSV_IC_2 Group', 'description': 'IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).'}, {'id': 'OG002', 'title': 'RSV_HA Group', 'description': 'Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}], 'classes': [{'title': 'Fever , Dosing at visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Fever , Dosing at visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia, Dosing at visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': 'Myalgia, Dosing at visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia, Dosing at visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Arthralgia, Dosing at visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Headache, Dosing at visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}, {'title': 'Headache, Dosing at visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue, Dosing at visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue, Dosing at visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)', 'description': 'Assessed solicited systemic events included fever (pyrexia), myalgia, arthralgia, headache, and fatigue. Fever is defined as body temperature greater or equal to (≥) 38 degrees Celsius (ºC). Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ES. Only participants with solicited systemic events at the specified timepoints were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number Of Participants Reporting Any Unsolicited Adverse Events (AEs) At Any Dose Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV_IC_1 Group', 'description': 'Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'OG001', 'title': 'RSV_IC_2 Group', 'description': 'IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).'}, {'id': 'OG002', 'title': 'RSV_HA Group', 'description': 'Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days (i.e., the day of vaccination and 29 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)', 'description': "An unsolicited AE is an AE that was not included in the list of solicited events. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ES. Only participants with unsolicited AEs at the specified timepoints were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV_IC_1 Group', 'description': 'Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'OG001', 'title': 'RSV_IC_2 Group', 'description': 'IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).'}, {'id': 'OG002', 'title': 'RSV_HA Group', 'description': 'Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}], 'classes': [{'title': 'Any SAEs', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Related SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Fatal SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Visit 1 (Day 1) up to Visit 4 (Visit 3 + 30-42 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of relation to study vaccination. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ES.'}, {'type': 'SECONDARY', 'title': 'Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV_IC_1 Group', 'description': 'Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'OG001', 'title': 'RSV_IC_2 Group', 'description': 'IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).'}, {'id': 'OG002', 'title': 'RSV_HA Group', 'description': 'Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}], 'classes': [{'title': 'Any pIMD', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Related pIMD', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Visit 1 (Day 1) up to Visit 4 (Visit 3 + 30-42 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)', 'description': 'pIMDs are a subset of AESIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any pIMDs = occurrence of the pIMDs regardless of relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ES.'}, {'type': 'SECONDARY', 'title': 'Number Of Participants With Any AEs Of Special Interest (AESIs) Specific To Renal And Lung SOT Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV_IC_1 Group', 'description': 'Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'OG001', 'title': 'RSV_IC_2 Group', 'description': 'IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Visit 1 (Day 1) up to Visit 4 (Visit 3 + 30-42 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)', 'description': 'AESIs include the acute rejection of transplant (specific to renal and lung SOT participants). Analysis was performed only on participants that received transplant in RSV\\_IC\\_1 and RSV\\_IC\\_2 groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ES. Only SOT participants that had data available at the specified timepoints were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Any SAEs, SAEs Related to Study Intervention and Fatal SAEs', 'timeFrame': 'From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of relation to study vaccination. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Any pIMDs and pIMDs Related to Study Intervention', 'timeFrame': 'From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)', 'description': 'pIMDs are a subset of AESIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any pIMDs = occurrence of the pIMDs regardless of relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Any AESIs Specific to Renal and Lung SOT Participants', 'timeFrame': 'From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)', 'description': 'AESIs include the acute rejection of transplant (specific to renal and lung SOT participants). Analysis was performed only on participants that received transplant in RSV\\_IC\\_1 and RSV\\_IC\\_2 groups.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RSV_IC_1 Group', 'description': 'Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'FG001', 'title': 'RSV_IC_2 Group', 'description': 'IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).'}, {'id': 'FG002', 'title': 'RSV_HA Group', 'description': 'Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '130'}, {'groupId': 'FG002', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '130'}, {'groupId': 'FG002', 'numSubjects': '113'}]}], 'dropWithdraws': [{'type': 'Unsolicited non-SAE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'SAEs/pIMDs/AESIs specific to SOT', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Ongoing at the time of Primary Completion Analysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '126'}, {'groupId': 'FG002', 'numSubjects': '112'}]}]}], 'recruitmentDetails': 'Participants from 48 study sites were enrolled in the study.', 'preAssignmentDetails': 'All participants enrolled were randomized to the Exposed set and started the study. Analysis presented includes data up to Primary Completion. Additional results will be provided within one year of study completion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '386', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'RSV_IC_1 Group', 'description': 'Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'BG001', 'title': 'RSV_IC_2 Group', 'description': 'IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).'}, {'id': 'BG002', 'title': 'RSV_HA Group', 'description': 'Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '61.4', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '63.8', 'spread': '8.2', 'groupId': 'BG002'}, {'value': '62.4', 'spread': '8.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'YEARS', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '170', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '216', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '263', 'groupId': 'BG003'}]}]}, {'title': 'All Other Races', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '123', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Races where 0\\<n\\<11 (i.e., ASIAN, AMERICAN INDIAN OR ALASKA NATIVE, BLACK OR AFRICAN AMERICAN, NOT REPORTED, MULTIPLE and UNKNOWN) are combined into one category ("All Other Races") to maintain participant confidentiality and privacy.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Exposed set included all participants that received at least one study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-11', 'size': 2050454, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-25T08:26', 'hasProtocol': True}, {'date': '2024-07-23', 'size': 1302102, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-25T08:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This study is an open label study.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 386}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2023-06-16', 'resultsFirstSubmitDate': '2025-06-25', 'studyFirstSubmitQcDate': '2023-06-16', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-25', 'studyFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RSV-A Serum Neutralizing Titers Expressed As Mean Geometric Increase (MGI) Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group', 'timeFrame': 'At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)', 'description': 'MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-A post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).'}, {'measure': 'RSV-B Serum Neutralizing Titers Expressed As MGI Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group', 'timeFrame': 'At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)', 'description': 'MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-B post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).'}], 'secondaryOutcomes': [{'measure': 'RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups', 'timeFrame': 'At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 in a subset of participants (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days)', 'description': 'Neutralizing titers were calculated as GMT and expressed in titers (Estimated Dilution 60 \\[ED60\\]).'}, {'measure': 'RSV-A and RSV-B Serum Neutralizing Titers Expressed as GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups', 'timeFrame': 'At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)', 'description': 'Neutralizing titers were calculated as GMT and expressed in titers (ED60).'}, {'measure': 'RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups', 'timeFrame': 'At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)', 'description': 'Group GMT was assessed for RSV\\_HA group over pooled RSV\\_IC group (combined RSV\\_IC\\_1 and RSV\\_IC\\_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\\_HA and Pooled RSV\\_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan.'}, {'measure': 'RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups', 'timeFrame': 'At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)', 'description': 'Group GMT of RSV\\_IC\\_2 over RSV\\_IC\\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\\_IC\\_1 and RSV\\_IC\\_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan.'}, {'measure': 'RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups', 'timeFrame': 'At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)', 'description': 'Group GMT of RSV\\_HA over RSV\\_IC\\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\\_IC\\_1 and RSV\\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.'}, {'measure': 'RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups', 'timeFrame': 'At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)', 'description': 'Group GMT of RSV\\_HA over RSV\\_IC\\_2 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\\_IC\\_2 and RSV\\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.'}, {'measure': 'RSV-A Serum Neutralizing Titers Expressed as Group GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups', 'timeFrame': 'At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)'}, {'measure': 'RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups', 'timeFrame': 'At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)', 'description': 'Group GMT was assessed for RSV\\_HA group over pooled RSV\\_IC group (combined RSV\\_IC\\_1 and RSV\\_IC\\_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\\_HA and Pooled RSV\\_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan.'}, {'measure': 'RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups', 'timeFrame': 'At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)', 'description': 'Group GMT ratio of RSV\\_IC\\_2 over RSV\\_IC\\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\\_IC\\_1 and RSV\\_IC\\_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan.'}, {'measure': 'RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups', 'timeFrame': 'At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)', 'description': 'Group GMT of RSV\\_HA over RSV\\_IC\\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\\_IC\\_1 and RSV\\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.'}, {'measure': 'RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups', 'timeFrame': 'At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)', 'description': 'Group GMT of RSV\\_HA over RSV\\_IC\\_2 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\\_IC\\_2 and RSV\\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.'}, {'measure': 'RSV-B Serum Neutralizing Titers Expressed as Group GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups', 'timeFrame': 'At Visit 5 (last dose +180-210 days) and Visit 6 (last dose + 350-380 days)'}, {'measure': 'RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI', 'timeFrame': 'At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days), each compared to Visit 1 (Day 1)', 'description': 'MGI was assessed at Visit 2 (in a subset of participants) over Visit 1 and Visit 3 over Visit 1 in RSV\\_HA and pooled RSV\\_IC (combined RSV\\_IC\\_1 and RSV\\_IC\\_2 groups), and at Visit 4 over Visit 1 in RSV\\_IC\\_1, RSV\\_IC\\_2, RSV\\_HA groups.'}, {'measure': 'RSV-A and RSV-B Serum Neutralizing Titers Expressed as MGI', 'timeFrame': 'At Visit 5 (last dose +180-210 days) and Visit 6 (last dose + 350-380 days), each compared with Visit 1 (Day 1)'}, {'measure': 'Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells', 'timeFrame': 'At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days)', 'description': 'CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific cluster of differentiation CD4+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV\\_IC\\_1 and RSV\\_IC\\_2 groups) and healthy participants (from RSV\\_HA group).'}, {'measure': 'CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells', 'timeFrame': 'At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days)', 'description': 'CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV\\_IC\\_1 and RSV\\_IC\\_2 groups) and healthy participants (from RSV\\_HA group).'}, {'measure': 'CMI Response in a Subset of Participants', 'timeFrame': 'At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)'}, {'measure': 'Number Of Participants Reporting Any Solicited Administration Site Events', 'timeFrame': 'Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)', 'description': 'Assessed solicited administration site events included pain, erythema (redness) and swelling, at the injection site. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.'}, {'measure': 'Number Of Participants Reporting Any Solicited Systemic Events', 'timeFrame': 'Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)', 'description': 'Assessed solicited systemic events included fever (pyrexia), myalgia, arthralgia, headache, and fatigue. Fever is defined as body temperature greater or equal to (≥) 38 degrees Celsius (ºC). Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.'}, {'measure': 'Number Of Participants Reporting Any Unsolicited Adverse Events (AEs) At Any Dose Administration', 'timeFrame': 'Within 30 days (i.e., the day of vaccination and 29 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)', 'description': "An unsolicited AE is an AE that was not included in the list of solicited events. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention."}, {'measure': 'Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs', 'timeFrame': 'From Visit 1 (Day 1) up to Visit 4 (Visit 3 + 30-42 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of relation to study vaccination. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination.'}, {'measure': 'Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention', 'timeFrame': 'From Visit 1 (Day 1) up to Visit 4 (Visit 3 + 30-42 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)', 'description': 'pIMDs are a subset of AESIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any pIMDs = occurrence of the pIMDs regardless of relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination.'}, {'measure': 'Number Of Participants With Any AEs Of Special Interest (AESIs) Specific To Renal And Lung SOT Participants', 'timeFrame': 'From Visit 1 (Day 1) up to Visit 4 (Visit 3 + 30-42 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)', 'description': 'AESIs include the acute rejection of transplant (specific to renal and lung SOT participants). Analysis was performed only on participants that received transplant in RSV\\_IC\\_1 and RSV\\_IC\\_2 groups.'}, {'measure': 'Number of Participants Reporting Any SAEs, SAEs Related to Study Intervention and Fatal SAEs', 'timeFrame': 'From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of relation to study vaccination. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination.'}, {'measure': 'Number of Participants Reporting Any pIMDs and pIMDs Related to Study Intervention', 'timeFrame': 'From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)', 'description': 'pIMDs are a subset of AESIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any pIMDs = occurrence of the pIMDs regardless of relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination.'}, {'measure': 'Number of Participants Reporting Any AESIs Specific to Renal and Lung SOT Participants', 'timeFrame': 'From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)', 'description': 'AESIs include the acute rejection of transplant (specific to renal and lung SOT participants). Analysis was performed only on participants that received transplant in RSV\\_IC\\_1 and RSV\\_IC\\_2 groups.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory syncytial virus', 'Vaccine', 'Immunogenicity', 'Safety'], 'conditions': ['Respiratory Syncytial Virus Infections']}, 'referencesModule': {'references': [{'pmid': '41199924', 'type': 'DERIVED', 'citation': 'Vyse A, Hockey C, Wright H, Ellsbury G. Could more adults than just those aged 75-79 years potentially benefit from vaccination against RSV: insights from UK data. J Pharm Policy Pract. 2025 Nov 4;18(1):2576618. doi: 10.1080/20523211.2025.2576618. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants and/or participant's parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n* Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living.\n* Written or witnessed informed consent obtained from the participant/participant's parent(s)/LAR(s) (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.\n* Female participants of nonchildbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and post-menopause.\n* Female participants of childbearing potential may be enrolled in the study if the participant has practiced adequate contraception from 1 month prior to study intervention administration and agreed to continue adequate contraception until study end for this study, and has a negative pregnancy test on the day of and prior to study intervention administration.\n\nSpecific inclusion criteria for renal/lung transplant patients:\n\n* A male or female, \\>=18 YoA at the time of signing the Informed consent form (ICF) or Informed assent form (IAF).\n* Written informed assent obtained from the participant (participant must be able to understand the informed assent) if he/she is less than legal age of consent, or written informed consent obtained from the participant if the participant has achieved legal age of consent.\n* Participant who has received an ABO compatible allogeneic renal or lung transplant (allograft) more than 12 months (365 days) prior to the first study intervention administration.\n* Participant receiving maintenance immunosuppressive therapy for the prevention of allograft rejection.\n\nSpecific inclusion criteria for renal transplant (RTx) patients:\n\n• Participant with stable renal function, stability defined as less than 20% variability between last two results of eGFR or in the opinion of the investigator after investigator review of more than the last two results of eGFRs and based on medical history.\n\nSpecific inclusion criteria for lung transplant (LTx) patients:\n\n• Participant with stable lung function, with stability defined as the stability in the FEV1 compared to post-transplant baseline FEV1 and based on medical history of the last 3 months, in the opinion of the investigator.\n\nSpecific inclusion criteria for healthy participants:\n\n* A male or female, \\>=50 YoA at the time of signing the ICF.\n* Healthy participants as established by medical history and clinical examination before entering the study.\n* Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration.\n* Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.\n\nExclusion Criteria:\n\nMedical conditions:\n\n* History of any reaction/ hypersensitivity likely to be exacerbated by any component of the study intervention.\n* Acute or chronic clinically significant cardiovascular or hepatic functional abnormality as determined by physical examination or laboratory screening tests.\n* Recurrent/uncontrolled neurological disorders or seizures. Participants with medically controlled chronic neurological diseases can be enrolled in the study if their condition will allow them to comply with the requirements of the protocol, with the help of a caregiver if needed.\n* Any history of dementia or any medical condition that moderately or severely impairs cognition.\n* Any condition which would make IM injection unsafe.\n* Significant underlying illness that would prevent completion of the study).\n* Acute disease and/or fever at the time of study intervention administration (\\>=38°C /100.4°F, oral or axillary). Participants with a minor illness without fever may be enrolled at the discretion of the investigator.\n* Bedridden participants.\n\nPrior/Concomitant therapy:\n\n* Use of any other investigational or non-registered product (drug, vaccine, or medical device) up to 30 days before the first dose administration (Day -30 to Day 1), or their planned use during the study period (up to Visit 6).\n* Previous vaccination with the study antigen (RSV), including investigational RSV vaccines.\n* Unexpected vaccine administration during a study should not occur 30 days prior to the first dose or 30 days after the last dose. For COVID-19 and inactivated/subunit/split influenza vaccines, this window is shortened to 14 days.\n\nPrior/Concurrent clinical study experience:\n\n• Concurrently participating in another active clinical study\n\nOther exclusion criteria:\n\n* Pregnant or lactating female participant.\n* Female participant planning to become pregnant or planning to discontinue contraceptive precautions.\n* History of chronic alcohol consumption and/or drug abuse\n* Participation of any study personnel or their immediate dependents.\n* Planned move during the study period that will prohibit participating in the study until study end.\n\nSpecific exclusion criteria for renal/lung transplant patients:\n\n* More than one organ transplanted. Dual organ is allowed.\n* History of events that may put the participant at increased risk for chronic allograft dysfunction.\n* Participant with an episode of allograft rejection over the previous 90 days prior to the first study intervention administration.\n* Histologic evidence of chronic allograft injury.\n* Active treatment for acute rejection.\n* Current diagnosis of malignancy (except non-melanoma skin cancer that does not require systemic therapy).\n* Any autoimmune conditions or pIMDs that may put the participant at increased risk.\n* Any confirmed or suspected HIV infection, primary immunodeficiency disease or ongoing CMV infection with a viremia \\>200 IU/mL.\n* Use of anti-CD20 or other B-cell monoclonal antibody agents for the prevention of allograft rejection within 274 days of first dose of study.\n* Use of investigational and non-registered immunosuppressants at the local/country level, unless specifically prescribed for the prevention of allograft rejection, and which are in process of approval, approved in other countries and locally available.\n* Evidence/high suspicion\\\\ of noncompliance/nonadherence to use of induction and/or maintenance immunosuppressive therapies.\n* Any clinically significant hematologic and/or biochemical laboratory abnormality.\n\nSpecific exclusion criteria for RTx patients:\n\n* Previous allograft loss secondary to recurrent primary kidney disease. Multiple consecutive kidney transplants are allowed if the reason is not recurrent primary kidney disease.\n* Evidence of significant proteinuria/albuminuria.\n\nSpecific exclusion criteria for LTx patients:\n\n* At study intervention administration visit, diagnosis of documented acute pulmonary infection within the 2 prior weeks.\n* Patients with diagnosis of chronic lung allograft dysfunction (decrement of \\>=20% in FEV1 compared to post-transplant baseline FEV1).\n\nSpecific exclusion criteria for healthy participants:\n\n* Any confirmed/suspected immunosuppressive/immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.\n* Unstable serious chronic illness.\n* Chronic administration of immune-modifying drugs (\\>14 days in total) and/or administration of long-acting immune-modifying treatments or planned administration at any time up to the end of the study.\n\n * Up to 3 months prior to the study intervention administration:\n * For corticosteroids -prednisone equivalent ≥20 mg/day, or equivalent. Inhaled, topical and intra-articular steroids are allowed.\n * Administration of immunoglobulins and/or any blood products or plasma derivatives.\n * Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs."}, 'identificationModule': {'nctId': 'NCT05921903', 'acronym': 'RSV OA=ADJ-023', 'briefTitle': 'A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase 2b, Randomized, Controlled, Open-label Study to Evaluate the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults (>=18 Years of Age) When Administered to Lung and Renal Transplant Recipients Comparing 1 Versus 2 Doses and Compared to Healthy Controls (>=50 Years of Age) Receiving 1 Dose.', 'orgStudyIdInfo': {'id': '219900'}, 'secondaryIdInfos': [{'id': '2023-503951-81-00', 'type': 'OTHER', 'domain': 'EU CT number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RSV_IC_1 group', 'description': 'Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).', 'interventionNames': ['Biological: RSVPreF3 OA Investigational Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'RSV_IC_2 group', 'description': 'IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).', 'interventionNames': ['Biological: RSVPreF3 OA Investigational Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RSV_HA group', 'description': 'Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).', 'interventionNames': ['Biological: RSVPreF3 OA Investigational Vaccine']}], 'interventions': [{'name': 'RSVPreF3 OA Investigational Vaccine', 'type': 'BIOLOGICAL', 'description': '0.5 mililiter dose was administered intramuscularly as 1 dose to RSV\\_IC\\_1 and RSV\\_HA groups, and 2 doses to RSV\\_IC\\_2 group.', 'armGroupLabels': ['RSV_HA group', 'RSV_IC_1 group', 'RSV_IC_2 group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198-2456', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 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