Viewing Study NCT05590403

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Ignite Creation Date: 2025-12-24 @ 7:44 PM
Ignite Modification Date: 2025-12-29 @ 9:08 PM
Study NCT ID: NCT05590403
Status: COMPLETED
Last Update Posted: 2025-03-06
First Post: 2022-10-18
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Canada', 'Germany', 'Japan', 'Netherlands', 'Poland', 'Spain', 'United States'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}}}}, '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 were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. SAEs and pIMDs were collected from Day 1 up to Month 6 post dose-administration. Related SAEs, related pIMDs and fatal SAEs were collected from Day 1 up to study end (Month 12).', 'description': 'Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.', 'eventGroups': [{'id': 'EG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.', 'otherNumAtRisk': 383, 'deathsNumAtRisk': 383, 'otherNumAffected': 325, 'seriousNumAtRisk': 383, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.', 'otherNumAtRisk': 192, 'deathsNumAtRisk': 192, 'otherNumAffected': 76, 'seriousNumAtRisk': 192, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.', 'otherNumAtRisk': 386, 'deathsNumAtRisk': 386, 'otherNumAffected': 318, 'seriousNumAtRisk': 386, 'deathsNumAffected': 1, 'seriousNumAffected': 15}, {'id': 'EG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.', 'otherNumAtRisk': 191, 'deathsNumAtRisk': 191, 'otherNumAffected': 74, 'seriousNumAtRisk': 191, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.', 'otherNumAtRisk': 381, 'deathsNumAtRisk': 381, 'otherNumAffected': 279, 'seriousNumAtRisk': 381, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Ocular retrobulbar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Abdominal wall haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Noninfective sialoadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Poor dental condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Administration site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Administration site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 386, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 381, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numEvents': 1, 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{'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '7906.0', 'groupId': 'OG000', 'lowerLimit': '7178.1', 'upperLimit': '8707.7'}, {'value': '7518.9', 'groupId': 'OG001', 'lowerLimit': '6843.2', 'upperLimit': '8261.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.09', 'estimateComment': 'The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-HA-RSV) (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 demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is less than (\\<) 1.5 at 1 month post RSVPreF3 OA vaccine administration.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 1 month after the RSVPreF3 OA vaccine administration (Day 31)', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated subjects. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the per protocol set (PPS) for humoral analysis which included all eligible participants who received the study intervention as per protocol, had RSV-A immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.'}, {'type': 'PRIMARY', 'title': 'RSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.8', 'groupId': 'OG000', 'lowerLimit': '78.3', 'upperLimit': '86.8'}, {'value': '80.2', 'groupId': 'OG001', 'lowerLimit': '75.6', 'upperLimit': '84.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.65', 'ciLowerLimit': '-8.54', 'ciUpperLimit': '3.28', 'estimateComment': 'The comparison is done using the difference of SRR (OA-RSV -Adults-HA-RSV)', 'groupDescription': 'To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is \\<10%, at 1 month post RSVPreF3 OA vaccine administration.'}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)', 'description': 'The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to 4 (\\>=4).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-A at pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.'}, {'type': 'PRIMARY', 'title': 'RSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '9024.8', 'groupId': 'OG000', 'lowerLimit': '8240.8', 'upperLimit': '9883.3'}, {'value': '8070.3', 'groupId': 'OG001', 'lowerLimit': '7385.2', 'upperLimit': '8819.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.02', 'estimateComment': 'The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-HA-RSV) (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 demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is \\<1.5 at 1 month post RSVPreF3 OA vaccine administration.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 1 month after the RSVPreF3 OA vaccine administration (Day 31)', 'description': 'Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had RSV-B immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.'}, {'type': 'PRIMARY', 'title': 'RSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.2', 'groupId': 'OG000', 'lowerLimit': '73.3', 'upperLimit': '82.6'}, {'value': '74.3', 'groupId': 'OG001', 'lowerLimit': '69.3', 'upperLimit': '78.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.95', 'ciLowerLimit': '-10.39', 'ciUpperLimit': '2.53', 'estimateComment': 'The comparison is done using the difference of SRR (OA-RSV -Adults-HA-RSV)', 'groupDescription': 'To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is \\<10%, at 1 month post RSVPreF3 OA vaccine administration.'}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)', 'description': 'The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) \\>=4.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-B at pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.'}, {'type': 'PRIMARY', 'title': 'RSV-A Neutralization Titers Expressed as Group GMT Titer in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '8925.1', 'groupId': 'OG000', 'lowerLimit': '8117.9', 'upperLimit': '9812.6'}, {'value': '7460.7', 'groupId': 'OG001', 'lowerLimit': '6786.8', 'upperLimit': '8201.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.73', 'ciUpperLimit': '0.96', 'estimateComment': 'The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-AIR-RSV) (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 demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is \\<1.5 at 1 month post RSVPreF3 OA vaccine administration.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)', 'description': 'Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the per protocol set (PPS) for humoral analysis which included all eligible participants who received the study intervention as per protocol, had RSV-A immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.'}, {'type': 'PRIMARY', 'title': 'RSV-A Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.8', 'groupId': 'OG000', 'lowerLimit': '82.8', 'upperLimit': '90.2'}, {'value': '80.2', 'groupId': 'OG001', 'lowerLimit': '75.6', 'upperLimit': '84.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.67', 'ciLowerLimit': '-12.26', 'ciUpperLimit': '-1.12', 'estimateComment': 'The comparison is done using the difference of SRR (OA-RSV -Adults-AIR-RSV)', 'groupDescription': 'To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is \\<10%, at 1 month post RSVPreF3 OA vaccine administration.'}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)', 'description': 'The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) \\>=4.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-A at pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.'}, {'type': 'PRIMARY', 'title': 'RSV-B Neutralization Titers Expressed as Group GMT in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '10048.6', 'groupId': 'OG000', 'lowerLimit': '9218.4', 'upperLimit': '10953.5'}, {'value': '8073.4', 'groupId': 'OG001', 'lowerLimit': '7406.4', 'upperLimit': '8800.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.71', 'ciUpperLimit': '0.91', 'estimateComment': 'The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-AIR-RSV) (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 demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is \\<1.5 at 1 month post RSVPreF3 OA vaccine administration.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 1 month after the RSVPreF3 OA vaccine administration (Day 31)', 'description': 'Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had RSV-B immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.'}, {'type': 'PRIMARY', 'title': 'RSV-B Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.6', 'groupId': 'OG000', 'lowerLimit': '77.1', 'upperLimit': '85.5'}, {'value': '74.3', 'groupId': 'OG001', 'lowerLimit': '69.3', 'upperLimit': '78.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.31', 'ciLowerLimit': '-13.52', 'ciUpperLimit': '-1.09', 'estimateComment': 'The comparison is done using the difference of SRR (OA-RSV -Adults-AIR-RSV)', 'groupDescription': 'To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is \\<10%, at 1 month post RSVPreF3 OA vaccine administration.'}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)', 'description': 'The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) \\>=4.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-B at pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '379', 'groupId': 'OG002'}, {'value': '189', 'groupId': 'OG003'}, {'value': '379', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'title': 'Erythema', 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '15.6'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.9'}, {'value': '14.5', 'groupId': 'OG002', 'lowerLimit': '11.1', 'upperLimit': '18.5'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '2.9'}, {'value': '12.1', 'groupId': 'OG004', 'lowerLimit': '9.0', 'upperLimit': '15.9'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '76.7', 'groupId': 'OG000', 'lowerLimit': '72.1', 'upperLimit': '80.8'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '15.7'}, {'value': '75.2', 'groupId': 'OG002', 'lowerLimit': '70.5', 'upperLimit': '79.5'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '9.6', 'upperLimit': '20.1'}, {'value': '61.2', 'groupId': 'OG004', 'lowerLimit': '56.1', 'upperLimit': '66.1'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '12.7'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.7'}, {'value': '11.6', 'groupId': 'OG002', 'lowerLimit': '8.6', 'upperLimit': '15.3'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '2.9'}, {'value': '7.7', 'groupId': 'OG004', 'lowerLimit': '5.2', 'upperLimit': '10.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)', 'description': 'Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the Exposed Set (ES), which included all participants who received the study intervention and had data for solicited administration site events analysis at the assessed timeframe.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '379', 'groupId': 'OG002'}, {'value': '190', 'groupId': 'OG003'}, {'value': '379', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000', 'lowerLimit': '21.6', 'upperLimit': '30.7'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '10.1'}, {'value': '20.8', 'groupId': 'OG002', 'lowerLimit': '16.9', 'upperLimit': '25.3'}, {'value': '10.0', 'groupId': 'OG003', 'lowerLimit': '6.1', 'upperLimit': '15.2'}, {'value': '12.9', 'groupId': 'OG004', 'lowerLimit': '9.7', 'upperLimit': '16.7'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000', 'lowerLimit': '39.0', 'upperLimit': '49.2'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '12.2', 'upperLimit': '23.4'}, {'value': '36.1', 'groupId': 'OG002', 'lowerLimit': '31.3', 'upperLimit': '41.2'}, {'value': '19.5', 'groupId': 'OG003', 'lowerLimit': '14.1', 'upperLimit': '25.8'}, {'value': '24.0', 'groupId': 'OG004', 'lowerLimit': '19.8', 'upperLimit': '28.6'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '35.8', 'groupId': 'OG000', 'lowerLimit': '31.0', 'upperLimit': '40.9'}, {'value': '16.8', 'groupId': 'OG001', 'lowerLimit': '11.8', 'upperLimit': '22.8'}, {'value': '27.7', 'groupId': 'OG002', 'lowerLimit': '23.3', 'upperLimit': '32.5'}, {'value': '17.4', 'groupId': 'OG003', 'lowerLimit': '12.3', 'upperLimit': '23.5'}, {'value': '21.1', 'groupId': 'OG004', 'lowerLimit': '17.1', 'upperLimit': '25.6'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000', 'lowerLimit': '34.3', 'upperLimit': '44.4'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '10.1'}, {'value': '32.5', 'groupId': 'OG002', 'lowerLimit': '27.8', 'upperLimit': '37.4'}, {'value': '14.2', 'groupId': 'OG003', 'lowerLimit': '9.6', 'upperLimit': '20.0'}, {'value': '21.4', 'groupId': 'OG004', 'lowerLimit': '17.4', 'upperLimit': '25.8'}]}]}, {'title': 'Fever', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '6.2'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.7'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '4.8'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '3.8'}, {'value': '1.6', 'groupId': 'OG004', 'lowerLimit': '0.6', 'upperLimit': '3.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)', 'description': 'Assessed solicited systemic events were arthralgia, fatigue, headache, myalgia and fever \\[temperature equal to or above (\\>=) 38 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the Exposed Set (ES), which included all participants who received the study intervention and had data for solicited systemic events analysis at the assessed timeframe.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Any Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '386', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}, {'value': '381', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '17.4'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '19.2'}, {'value': '15.3', 'groupId': 'OG002', 'lowerLimit': '11.8', 'upperLimit': '19.3'}, {'value': '10.5', 'groupId': 'OG003', 'lowerLimit': '6.5', 'upperLimit': '15.7'}, {'value': '16.3', 'groupId': 'OG004', 'lowerLimit': '12.7', 'upperLimit': '20.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 30-day follow up period after vaccination (vaccine or placebo administered on Day 1)', 'description': "Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the Exposed Set (ES), which included all participants who received the study intervention and had data for assessed timeframe and unsolicited events analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Any Serious Adverse Events (SAEs) Within 6 Months of Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '386', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}, {'value': '381', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '2.3'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '5.2'}, {'value': '3.9', 'groupId': 'OG002', 'lowerLimit': '2.2', 'upperLimit': '6.3'}, {'value': '2.1', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '5.3'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '1.1', 'upperLimit': '4.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1)', 'description': 'An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Any Onset Potential Immune Mediated Diseases (pIMDs) Within 6 Months of Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '386', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}, {'value': '381', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1.9'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '2.6'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '2.9'}, {'value': '0.8', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '2.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1)', 'description': 'pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting SAEs Related to Study Intervention Administration Within 12 Months of Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '386', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}, {'value': '381', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1.9'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '1.0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.9'}, {'value': '0.3', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '1.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)', 'description': 'An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting pIMDs Related to Study Intervention Administration Within 12 Months of Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '386', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}, {'value': '381', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1.9'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '1.0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.9'}, {'value': '0.3', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '1.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)', 'description': 'pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Any Fatal SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '386', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}, {'value': '381', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1.9'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '2.6'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '2.9'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '1.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)', 'description': 'An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.'}, {'type': 'SECONDARY', 'title': 'RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}, {'value': '186', 'groupId': 'OG003'}, {'value': '364', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}, {'value': '186', 'groupId': 'OG003'}, {'value': '364', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '768.8', 'groupId': 'OG000', 'lowerLimit': '704.7', 'upperLimit': '838.9'}, {'value': '772.0', 'groupId': 'OG001', 'lowerLimit': '677.9', 'upperLimit': '879.1'}, {'value': '779.5', 'groupId': 'OG002', 'lowerLimit': '725.5', 'upperLimit': '837.6'}, {'value': '729.8', 'groupId': 'OG003', 'lowerLimit': '648.6', 'upperLimit': '821.0'}, {'value': '775.7', 'groupId': 'OG004', 'lowerLimit': '709.9', 'upperLimit': '847.5'}]}]}, {'title': 'Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '344', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}, {'value': '348', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7925.4', 'groupId': 'OG000', 'lowerLimit': '7125.6', 'upperLimit': '8815.0'}, {'value': '796.9', 'groupId': 'OG001', 'lowerLimit': '696.4', 'upperLimit': '912.0'}, {'value': '8804.1', 'groupId': 'OG002', 'lowerLimit': '7953.3', 'upperLimit': '9746.0'}, {'value': '774.7', 'groupId': 'OG003', 'lowerLimit': '683.0', 'upperLimit': '878.6'}, {'value': '7498.8', 'groupId': 'OG004', 'lowerLimit': '6759.5', 'upperLimit': '8319.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)', 'description': 'Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for the assessed analysis, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only those participants with data available at the time of the analysis were reported in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}, {'value': '355', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}, {'value': '355', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3850.7', 'groupId': 'OG000', 'lowerLimit': '3448.6', 'upperLimit': '4299.7'}, {'value': '849.6', 'groupId': 'OG001', 'lowerLimit': '748.9', 'upperLimit': '963.9'}, {'value': '3980.6', 'groupId': 'OG002', 'lowerLimit': '3608.6', 'upperLimit': '4391.1'}, {'value': '854.2', 'groupId': 'OG003', 'lowerLimit': '756.2', 'upperLimit': '965.0'}, {'value': '3846.3', 'groupId': 'OG004', 'lowerLimit': '3469.7', 'upperLimit': '4263.7'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '327', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '334', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3192.9', 'groupId': 'OG000', 'lowerLimit': '2855.1', 'upperLimit': '3570.7'}, {'value': '965.1', 'groupId': 'OG001', 'lowerLimit': '846.8', 'upperLimit': '1099.9'}, {'value': '3075.1', 'groupId': 'OG002', 'lowerLimit': '2772.2', 'upperLimit': '3411.0'}, {'value': '971.8', 'groupId': 'OG003', 'lowerLimit': '864.6', 'upperLimit': '1092.4'}, {'value': '3080.4', 'groupId': 'OG004', 'lowerLimit': '2764.8', 'upperLimit': '3432.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 6 months and at 12 months after study intervention administration', 'description': 'Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for the assessed analysis, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only those participants with data available at the time of the analysis were reported in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}, {'value': '186', 'groupId': 'OG003'}, {'value': '364', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}, {'value': '186', 'groupId': 'OG003'}, {'value': '364', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1091.1', 'groupId': 'OG000', 'lowerLimit': '1000.3', 'upperLimit': '1190.2'}, {'value': '1197.7', 'groupId': 'OG001', 'lowerLimit': '1055.7', 'upperLimit': '1358.8'}, {'value': '1141.4', 'groupId': 'OG002', 'lowerLimit': '1050.5', 'upperLimit': '1240.0'}, {'value': '1167.2', 'groupId': 'OG003', 'lowerLimit': '1035.0', 'upperLimit': '1316.1'}, {'value': '1109.1', 'groupId': 'OG004', 'lowerLimit': '1020.6', 'upperLimit': '1205.3'}]}]}, {'title': 'Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '344', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}, {'value': '347', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8971.9', 'groupId': 'OG000', 'lowerLimit': '8109.6', 'upperLimit': '9925.8'}, {'value': '1145.3', 'groupId': 'OG001', 'lowerLimit': '1012.4', 'upperLimit': '1295.5'}, {'value': '9943.0', 'groupId': 'OG002', 'lowerLimit': '9035.8', 'upperLimit': '10941.4'}, {'value': '1141.8', 'groupId': 'OG003', 'lowerLimit': '1007.4', 'upperLimit': '1294.2'}, {'value': '8169.3', 'groupId': 'OG004', 'lowerLimit': '7412.6', 'upperLimit': '9003.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)', 'description': 'Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for the assessed analysis, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only those participants with data available at the time of the analysis were reported in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}, {'value': '355', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}, {'value': '355', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3880.7', 'groupId': 'OG000', 'lowerLimit': '3488.4', 'upperLimit': '4317.0'}, {'value': '1003.2', 'groupId': 'OG001', 'lowerLimit': '875.5', 'upperLimit': '1149.4'}, {'value': '4020.8', 'groupId': 'OG002', 'lowerLimit': '3635.9', 'upperLimit': '4446.5'}, {'value': '942.1', 'groupId': 'OG003', 'lowerLimit': '825.4', 'upperLimit': '1075.3'}, {'value': '3710.4', 'groupId': 'OG004', 'lowerLimit': '3361.0', 'upperLimit': '4096.1'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '327', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '334', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3562.8', 'groupId': 'OG000', 'lowerLimit': '3176.0', 'upperLimit': '3996.7'}, {'value': '1218.6', 'groupId': 'OG001', 'lowerLimit': '1038.8', 'upperLimit': '1429.5'}, {'value': '3669.9', 'groupId': 'OG002', 'lowerLimit': '3287.1', 'upperLimit': '4097.3'}, {'value': '1153.5', 'groupId': 'OG003', 'lowerLimit': '996.6', 'upperLimit': '1335.2'}, {'value': '3527.7', 'groupId': 'OG004', 'lowerLimit': '3177.5', 'upperLimit': '3916.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 6 months and at 12 months after study intervention administration', 'description': 'Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for the assessed analysis, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only those participants with data available at the time of the analysis were reported in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '102.7', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '125.6', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '161.5', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '114.7', 'spread': '0.9', 'groupId': 'OG003'}, {'value': '111.3', 'spread': '0.9', 'groupId': 'OG004'}]}]}, {'title': 'Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1282.5', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '167.7', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '1043.6', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '131.9', 'spread': '0.8', 'groupId': 'OG003'}, {'value': '1016.9', 'spread': '0.8', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)', 'description': 'Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.', 'unitOfMeasure': 'CD4+ T cells/million cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Cell-Mediated immune (CMI) sub-cohort of the PPS,which included all eligible participants who received the study intervention as per protocol,had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD4+T cells, complied with blood draw intervals,without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.Only the participants with data available at the time of the analysis were reported'}, {'type': 'SECONDARY', 'title': 'Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '825.6', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '140.5', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '662.9', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '39.2', 'spread': '1.0', 'groupId': 'OG003'}, {'value': '763.5', 'spread': '0.5', 'groupId': 'OG004'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '492.0', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '175.8', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '335.5', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '59.4', 'spread': '1.0', 'groupId': 'OG003'}, {'value': '414.1', 'spread': '0.7', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 6 months and at 12 months after study intervention administration', 'description': 'Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.', 'unitOfMeasure': 'CD4+ T cells/million cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on CMI sub-cohort of the PPS, which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD4+ T cells, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only the participants with data available at the time of the analysis were reported.'}, {'type': 'SECONDARY', 'title': 'Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '15.5', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '10.8', 'spread': '1.1', 'groupId': 'OG003'}, {'value': '12.0', 'spread': '1.0', 'groupId': 'OG004'}]}]}, {'title': 'Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '18.1', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '1.1', 'groupId': 'OG003'}, {'value': '12.0', 'spread': '1.2', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)', 'description': 'Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.', 'unitOfMeasure': 'CD8+ T cells/million cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on CMI sub-cohort of the PPS, which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD8+ T cells, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only the participants with data available at the time of the analysis were reported.'}, {'type': 'SECONDARY', 'title': 'Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'OG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'OG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '23.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '27.6', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '14.0', 'spread': '1.0', 'groupId': 'OG003'}, {'value': '14.8', 'spread': '1.1', 'groupId': 'OG004'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '23.0', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '16.2', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '6.6', 'spread': '1.1', 'groupId': 'OG003'}, {'value': '14.9', 'spread': '1.0', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 6 months and at 12 months after study intervention administration', 'description': 'Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.', 'unitOfMeasure': 'CD8+ T cells/million cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on CMI sub-cohort of the PPS, which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD8+ T cells, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only the participants with data available at the time of the analysis were reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-Lower respiratory tract disease (RSV-LRTD), aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'FG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'FG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'FG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'FG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '383'}, {'groupId': 'FG001', 'numSubjects': '192'}, {'groupId': 'FG002', 'numSubjects': '386'}, {'groupId': 'FG003', 'numSubjects': '191'}, {'groupId': 'FG004', 'numSubjects': '381'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '363'}, {'groupId': 'FG001', 'numSubjects': '184'}, {'groupId': 'FG002', 'numSubjects': '369'}, {'groupId': 'FG003', 'numSubjects': '180'}, {'groupId': 'FG004', 'numSubjects': '369'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Consent withdrawal, not due to a (S)AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Migrated / moved from the study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Adverse event requiring expedited reporting', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Out of 1544 participants enrolled in this study, 1534 participants received at least one study intervention, from which 1 participant in OA-RSV group received placebo instead of RSVPreF3 OA vaccine and was excluded from the group. Therefore, the Exposed set included 1533 participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}, {'value': '191', 'groupId': 'BG003'}, {'value': '381', 'groupId': 'BG004'}, {'value': '1533', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'BG001', 'title': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'BG002', 'title': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'BG003', 'title': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.'}, {'id': 'BG004', 'title': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '54.7', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '55.3', 'spread': '2.8', 'groupId': 'BG002'}, {'value': '55.6', 'spread': '2.8', 'groupId': 'BG003'}, {'value': '64.1', 'spread': '2.9', 'groupId': 'BG004'}, {'value': '58.6', 'spread': '7.5', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'YEARS', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}, {'value': '188', 'groupId': 'BG004'}, {'value': '799', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '193', 'groupId': 'BG004'}, {'value': '734', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '219', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '335', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}, {'value': '330', 'groupId': 'BG004'}, {'value': '1312', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-30', 'size': 2115265, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-13T03:54', 'hasProtocol': True}, {'date': '2024-02-28', 'size': 1982437, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-11T08:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Observer-blind for Cohort 1 (Day1-Day 31) and single-blind afterwards and open-label for Cohort 2'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1544}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2022-10-18', 'resultsFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2022-10-18', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-25', 'studyFirstPostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group', 'timeFrame': 'At 1 month after the RSVPreF3 OA vaccine administration (Day 31)', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated subjects. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.'}, {'measure': 'RSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group', 'timeFrame': 'At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)', 'description': 'The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to 4 (\\>=4).'}, {'measure': 'RSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group', 'timeFrame': 'At 1 month after the RSVPreF3 OA vaccine administration (Day 31)', 'description': 'Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.'}, {'measure': 'RSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group', 'timeFrame': 'At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)', 'description': 'The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) \\>=4.'}, {'measure': 'RSV-A Neutralization Titers Expressed as Group GMT Titer in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group', 'timeFrame': 'At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)', 'description': 'Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.'}, {'measure': 'RSV-A Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group', 'timeFrame': 'At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)', 'description': 'The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) \\>=4.'}, {'measure': 'RSV-B Neutralization Titers Expressed as Group GMT in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group', 'timeFrame': 'At 1 month after the RSVPreF3 OA vaccine administration (Day 31)', 'description': 'Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.'}, {'measure': 'RSV-B Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group', 'timeFrame': 'At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)', 'description': 'The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) \\>=4.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling)', 'timeFrame': 'During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)', 'description': 'Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.'}, {'measure': 'Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness)', 'timeFrame': 'During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)', 'description': 'Assessed solicited systemic events were arthralgia, fatigue, headache, myalgia and fever \\[temperature equal to or above (\\>=) 38 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.'}, {'measure': 'Percentage of Participants Reporting Any Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 30-day follow up period after vaccination (vaccine or placebo administered on Day 1)', 'description': "Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event."}, {'measure': 'Percentage of Participants Reporting Any Serious Adverse Events (SAEs) Within 6 Months of Vaccination', 'timeFrame': 'From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1)', 'description': 'An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.'}, {'measure': 'Percentage of Participants Reporting Any Onset Potential Immune Mediated Diseases (pIMDs) Within 6 Months of Vaccination', 'timeFrame': 'From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1)', 'description': 'pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.'}, {'measure': 'Percentage of Participants Reporting SAEs Related to Study Intervention Administration Within 12 Months of Vaccination', 'timeFrame': 'From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)', 'description': 'An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.'}, {'measure': 'Percentage of Participants Reporting pIMDs Related to Study Intervention Administration Within 12 Months of Vaccination', 'timeFrame': 'From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)', 'description': 'pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.'}, {'measure': 'Percentage of Participants Reporting Any Fatal SAEs', 'timeFrame': 'From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)', 'description': 'An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.'}, {'measure': 'RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention', 'timeFrame': 'At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)', 'description': 'Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.'}, {'measure': 'RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention', 'timeFrame': 'At 6 months and at 12 months after study intervention administration', 'description': 'Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.'}, {'measure': 'RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention', 'timeFrame': 'At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)', 'description': 'Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.'}, {'measure': 'RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention', 'timeFrame': 'At 6 months and at 12 months after study intervention administration', 'description': 'Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.'}, {'measure': 'Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention', 'timeFrame': 'At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)', 'description': 'Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.'}, {'measure': 'Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention', 'timeFrame': 'At 6 months and at 12 months after study intervention administration', 'description': 'Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.'}, {'measure': 'Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention', 'timeFrame': 'At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)', 'description': 'Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.'}, {'measure': 'Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12', 'timeFrame': 'At 6 months and at 12 months after study intervention administration', 'description': 'Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory syncytial virus', 'Immunogenicity', 'Safety', 'Increased risk of respiratory syncytial virus lower respiratory tract disease', 'Adults aged 50-59 years of age', 'Older adults 60 years of age and above'], 'conditions': ['Respiratory Syncytial Virus Infections']}, 'referencesModule': {'references': [{'pmid': '41194599', 'type': 'DERIVED', 'citation': 'Ferguson M, Schwarz TF, Nunez SA, Rodriguez-Garcia J, Mital M, Zala C, Pek B, Schmitt B, Toursarkissian N, Ochoa Mazarro D, Grosskopf J, Voors-Pette C, Mehta H, Amare Hailemariam H, Gerard C, Damaso S, David MP, Descamps D, Hill J, Vandermeulen C, Hulstrom V. Immune persistence and safety of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in adults 50-59 years of age, including at-increased-risk adults: A randomized controlled trial. Hum Vaccin Immunother. 2025 Dec;21(1):2579335. doi: 10.1080/21645515.2025.2579335. Epub 2025 Nov 5.'}, {'pmid': '39099093', 'type': 'DERIVED', 'citation': 'Ferguson M, Schwarz TF, Nunez SA, Rodriguez-Garcia J, Mital M, Zala C, Schmitt B, Toursarkissian N, Mazarro DO, Grosskopf J, Voors-Pette C, Mehta H, Hailemariam HA, de Heusch M, Salaun B, Damaso S, David MP, Descamps D, Hill J, Vandermeulen C, Hulstrom V; RSV OA=ADJ-018 Study Group. Noninferior Immunogenicity and Consistent Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years Compared to >/=60 Years of Age. Clin Infect Dis. 2024 Oct 15;79(4):1074-1084. doi: 10.1093/cid/ciae364.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to demonstrate the non-inferiority (NI) of the immune response and evaluate safety of RSVPreF3 older adults (OA) investigational vaccine in adults 50-59 years of age (YOA), including those who are at increased risk (AIR) of respiratory syncytial virus (RSV)-lower respiratory tract disease (LRTD), versus adults \\>=60 YOA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol\n* Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.\n\n 1\\. Specific inclusion criteria for all participants in Cohort 1 (Adults HA-RSV Group, Adults HA-Placebo Group, Adults AIR-RSV Group \\& Adults AIR-Placebo Group)\n* A male or female participant 50-59 YOA at the time of the study intervention administration.\n* Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause.\n* Female participants of childbearing potential may be enrolled in the study, if the participant:\n\n * has practiced adequate contraception from 1 month prior to study intervention administration until study end for this study, and\n * has a negative pregnancy test on the day of study intervention administration.\n\nSpecific inclusion criteria for participants in the Adults-HA Sub-cohort\n\n* Healthy participants as established by medical history and clinical examination before entering into the study.\n* Participants with chronic stable medical conditions with or without specific treatment, such as hypertension, hypercholesterolemia, or hypothyroidism, and who are not at increased risk for RSV-LRTD , are allowed to participate in this study if considered by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months).\n\nSpecific inclusion criteria for participants in the Adults-AIR Sub cohort\n\nParticipants should be diagnosed with at least 1 of the following medical conditions and have a stable condition (no changes in the treatment or disease severity in the past 3 months):\n\n* Chronic pulmonary disease resulting in activity restricting symptoms or use of long-term medication\n* Chronic cardiovascular disease\n* Diabetes mellitus: types 1 and 2\n* Other diseases at increased risk for RSV-LRTD disease\n\n * Chronic kidney disease\n * Chronic liver disease 2. Specific inclusion criteria for Cohort 2 (OA-RSV Group)\n* A male or female participant ≥60 YOA at the time of the study intervention administration.\n* Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease are allowed to participate in this study if considered by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months).\n* Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.\n\nExclusion Criteria:\n\nMedical conditions\n\n* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.\n* Hypersensitivity to latex.\n* Unstable chronic illness.\n* Any history of dementia or any medical condition that moderately or severely impairs cognition.\n* Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol. Study participants may decide to assign a caregiver to help them complete the study procedures.\n* Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.\n* Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.\n\nPrior/Concomitant therapy\n\n* Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Visit 4, Month 12).\n* Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration, with the exception of inactivated and subunit influenza vaccines or COVID-19 vaccines (fully licensed or with EUA) which can be administered up to 14 days before or from 14 days after the study intervention administration.\n\nNote: In case an emergency mass vaccination for an unforeseen public health threat is recommended and/or organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.\n\n* Previous vaccination with an RSV vaccine, including investigational RSV vaccines.\n* Chronic administration of immune-modifying drugs (defined as more than 14 consecutive 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, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical 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 including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.\n\nPrior/Concurrent clinical study experience\n\n• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or invasive medical device).\n\nOther exclusions Other exclusions for all participants\n\n* History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.\n* Bedridden participants.\n* Planned move during the study period that will prohibit participating in the study until study end.\n* Participation of any study personnel or their immediate dependents, family, or household members.\n\nOther exclusions for Cohort 1\n\n* Pregnant or lactating female.\n* Female planning to become pregnant or planning to discontinue contraceptive precautions.'}, 'identificationModule': {'nctId': 'NCT05590403', 'briefTitle': 'A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase 3, Observer-blind, Randomized, Placebo-controlled Study to Evaluate the Non-inferiority of the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults ≥60 Years of Age', 'orgStudyIdInfo': {'id': '219238'}, 'secondaryIdInfos': [{'id': '2022-001981-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adults HA-RSV Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-Lower respiratory tract disease (RSV-LRTD), aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.', 'interventionNames': ['Biological: RSVPreF3 OA investigational vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Adults HA-Placebo Group', 'description': 'Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Adults AIR-RSV Group', 'description': 'Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.', 'interventionNames': ['Biological: RSVPreF3 OA investigational vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Adults AIR-Placebo Group', 'description': 'Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'OA-RSV Group', 'description': 'Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.', 'interventionNames': ['Biological: RSVPreF3 OA investigational vaccine']}], 'interventions': [{'name': 'RSVPreF3 OA investigational vaccine', 'type': 'BIOLOGICAL', 'description': 'One dose administered intramuscularly at Day 1.', 'armGroupLabels': ['Adults AIR-RSV Group', 'Adults HA-RSV Group', 'OA-RSV Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One dose administered intramuscularly at Day 1.', 'armGroupLabels': ['Adults AIR-Placebo Group', 'Adults HA-Placebo Group']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.', 'ipdSharing': 'YES', 'description': 'IPD for this study will be made available via the Clinical Study Data Request site.', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}