Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT04785612
Status:
COMPLETED
Last Update Posted:
2024-08-07
First Post:
2021-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of RSVpreF Vaccination and RSV Challenge in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a.mann@hvivo.com', 'phone': '+44(0)7738321671', 'title': 'Alex Mann', 'organization': 'hVIVO'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.', 'eventGroups': [{'id': 'EG000', 'title': 'RSVPreF (From Vaccination Until Viral Challenge)', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection on Day -28', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 12, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo (From Vaccination Until Viral Challenge)', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine on Day -28', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 9, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'RSVPreF (From Viral Challenge Until Day 28)', 'description': 'Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 2, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo (From Viral Challenge Until Day 28)', 'description': 'Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 1, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'RSVPreF (From Day 28 Until Day155)', 'description': 'Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 2, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Placebo (From Day 28 Until Day155)', 'description': 'Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Varicella zoster virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}], 'seriousEvents': [{'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35}, {'groupId': 'EG001', 'numAtRisk': 35}, {'groupId': 'EG002', 'numAtRisk': 35}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 35}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35}, {'groupId': 'EG001', 'numAtRisk': 35}, {'groupId': 'EG002', 'numAtRisk': 35}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Viral Load-time Curve (VL-AUC) of RSV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '19.02'}, {'value': '96.65', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '675.32'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 2 to Day 12', 'description': 'The VL-AUC of RSV determined by qRT-PCR from nasal wash samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.', 'unitOfMeasure': 'h*log10 PFU/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis used the ITT (Intent-to-Treat) Challenge Analysis Set which included all participants randomly assigned to study intervention and who took a dose of study vaccine/placebo and were given viral challenge.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With RT-PCR Confirmed (Detected) Incidence of Symptomatic Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 2 to Day 12', 'description': 'RT-PCR-confirmed symptomatic RSV infection defined as:\n\n\\- Two detectable qRT-PCR reported on 2 or more consecutive days (any two detectable (≥LLOD) qRT-PCR measurements reported over 4 consecutive scheduled timepoints).\n\nand\n\n\\- Either one or more positive clinical symptoms from different categories in the symptom scoring system or one Grade 2 symptom from any category', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sum Total Symptoms Diary Card Score (TSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '199.8', 'groupId': 'OG000'}, {'value': '28.9', 'spread': '120.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 to Day 12', 'description': 'The sum total symptoms score is the sum of all scores from the first assessment on Day 1 to the first assessment on Day 12 (34 assessments). Symptom scores were collected three times daily starting one day post-viral challenge (Day +1) up to discharge from quarantine using a participant self-reportable 13-symptoms card. Clinical symptoms include runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptoms from 0 (no symptoms) - 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. For each assessment, an individual total symptom score was derived as the total of the scores given to the 13 symptoms on that symptom score card. Individual total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With RT-PCR Confirmed (Quantifiable) Incidence of Symptomatic Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 2 to Day 12', 'description': 'RT-PCR confirmed RSV infection defined as\n\n* Two quantifiable PCR measures reported on 2 or more consecutive days (any two quantifiable (≥LLOQ) qRT-PCR measurements reported over 4 consecutive scheduled timepoints), and\n* Either one or more positive clinical symptoms from different categories in the symptom scoring system or one Grade 2 symptom from any category', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Culture Lab-confirmed Reduction of Symptomatic RSV Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 2 to Day 12', 'description': 'Culture lab-confirmed symptomatic RSV infection defined as:\n\n* One quantifiable viral culture and\n* Either one or more positive clinical symptoms from different categories in the symptom scoring system or one Grade 2 symptom from any category', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Viral Load of RSV by qRT-PCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.1080'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '6.9990'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 2 to Day 12', 'description': 'Reduction in Peak viral load of RSV determined by quantifiable qRT-PCR from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.', 'unitOfMeasure': 'log 10 copies/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Viral Load of RSV by Viral Culture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '1.921', 'spread': '2.3837', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 2 to Day 12', 'description': 'Peak viral load of RSV determined by quantifiable viral culture from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.', 'unitOfMeasure': 'log 10 PFU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Quantifiable qRT-PCR Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '54.4'}, {'value': '131.6', 'comment': 'NA - the upper quartile was not estimable due to more than 25% of participants being censored, as they had not met the required criteria, at the end of their observation period.', 'groupId': 'OG001', 'lowerLimit': '72.1', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 2 to Day 12', 'description': 'Duration (time in hours) of quantifiable qRT-PCR measurements from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Quantitative Viral Culture Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '83.1', 'groupId': 'OG001', 'lowerLimit': '60.2', 'upperLimit': '95.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 2 to Day 12', 'description': 'Duration (time in hours) of quantitative viral culture measurements from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only infected subjects are included in the analysis, hence 0 for RSVPreF and 13 for Placebo'}, {'type': 'SECONDARY', 'title': 'VL-AUC Determined by Quantitative Viral Culture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '91.91', 'spread': '127.883', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 2 to Day 12', 'description': 'VL-AUC of RSV as determined by quantitative viral culture on nasal samples starting two days post-viral challenge (Day +2) up to discharge from quarantine', 'unitOfMeasure': 'h*log10 PFU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve Over Time of Total Clinical Symptoms (TSS-AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '52.85', 'spread': '105.250', 'groupId': 'OG000'}, {'value': '230.76', 'spread': '277.988', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 12', 'description': 'Data presented is hours \\* score. TSS-AUC (trapezium rule) as measured by graded symptom scoring system collected 3 times daily starting Day +1 up to Day 12am using a participant self-reportable 13-symptoms card, the max number of diary cards included in the AUC calculation is 34, the maximum time period is 264hrs.\n\nClinical symptoms included runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptom from 0 (no symptoms) - 3(severe). Shortness of breath and wheeze had an additional scoring option of grade 4. Dairy card total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4).\n\nThe range of TSS AUC scores are between 0 and 10,824 hours\\*score (maximum of 264x41).', 'unitOfMeasure': 'hours * score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Symptoms Diary Card Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '3.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 12', 'description': 'Peak TSS for each participant is defined as the diary card total with the worst score (highest). The symptom scoring system was collected three times daily starting one day post-viral challenge (Day +1) up to discharge from quarantine using a participant self-reportable 13-symptoms card. Clinical symptoms include runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptoms from 0 (no symptoms) - 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. For each assessment, an individual total symptom score was derived as the total of the scores given to the 13 symptoms on that symptom score card. Individual total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Daily Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '2.16', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '2.78', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '2.77', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '3.04', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '3.30', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.59', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.51', 'groupId': 'OG001'}]}]}, {'title': 'Day 12', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 12', 'description': 'Peak daily symptom score was derived, for each day from Day 1 to Day 12, as the maximum of the 3 total symptoms scores on that day, providing 11 scores each. The symptoms were collected three times daily starting one day post-viral challenge (Day +1) up to discharge from quarantine using a participant self-reportable 13-symptoms card. Clinical symptoms include runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptoms from 0 (no symptoms) - 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. For each assessment, an individual total symptom score was derived as the total of the scores given to the 13 symptoms on that symptom score card. Individual total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage Number of Participants With Grade 2 or Higher Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 12', 'description': 'Number (%) of participants with Grade 2 or higher symptoms (on any occasion from Day 1 to Day 12)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Occurrence of at Least Two Positive Quantifiable qRT-PCR Measurements on 2 or More Consecutive Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 2 to Day 12', 'description': 'The number of participants with at least two quantifiable positive (≥LLOQ) qRT-PCR nasal sample measurements across 4 consecutive visits', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Occurrence of at Least Two Positive Detectable qRT-PCR Measurements on 2 or More Consecutive Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 2 to Day 12', 'description': 'The proportion of participants with at least two positive detectable qRT-PCR nasal sample measurements across 4 consecutive visits', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Occurrence of at Least One Positive Quantitative Cell Culture Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 2 to Day 12', 'description': 'The proportion of participants with at least one quantifiable positive (≥LLOQ) nasal sample viral culture starting two days post-viral challenge (Day+2) up to discharge from quarantine. Viral culture is only done for samples where qRT-PCR is positive (detectable), when the qRT-PCR is negative the viral culture is assumed to be 0 for any endpoint derivations.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Mucus Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '6.367', 'spread': '9.8246', 'groupId': 'OG000'}, {'value': '29.135', 'spread': '36.2811', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 12', 'description': 'Total weight of mucus produced starting one day post-viral challenge (Day +1) up to discharge from quarantine.\n\nThe mean sum of all mucus produced from Day 1 to Day 12 is reported in data table.', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Tissue Number', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '16.9', 'spread': '22.35', 'groupId': 'OG000'}, {'value': '41.7', 'spread': '44.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 12', 'description': 'Total number of tissues used by participants starting one day post-viral challenge (Day +1) up to discharge from quarantine.', 'unitOfMeasure': 'Tissues', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Solicited Local Reactions Within 7 Days After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days post vaccination', 'description': 'Local reactions include pain at injection site, redness and swelling', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants who completed the vaccination diary card'}, {'type': 'SECONDARY', 'title': 'Number of Systemic Events Within 7 Days After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days post vaccination', 'description': 'Systemic reactions included fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain. Each of these items was collected on a four-point scale including, none, mild, moderate, and severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants who completed the vaccination diary card'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Occurrence of Unsolicited Adverse Events (AEs) Post Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of participants with at least one unsolicited adverse events (AEs) within 30 days after vaccination. Unsolicited AEs were all AEs for which participants were not specifically questioned in the participant diary.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Occurrence of Medically Attended AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF (From Vaccination Until Viral Challenge)', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection on Day -28'}, {'id': 'OG001', 'title': 'Placebo (From Vaccination Until Viral Challenge)', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine on Day -28'}, {'id': 'OG002', 'title': 'RSVPreF (From Viral Challenge Until Day 28)', 'description': 'Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28'}, {'id': 'OG003', 'title': 'Placebo (From Viral Challenge Until Day 28)', 'description': 'Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving a single intramuscular dose of placebo on Day -28.'}, {'id': 'OG004', 'title': 'RSVPreF (From Day 28 Until Day155)', 'description': 'Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of 120 mcg RSVpreF on Day -28 and RSV-A Memphis 37b virus on Day 0'}, {'id': 'OG005', 'title': 'Placebo (From Day 28 Until Day155)', 'description': 'Participants completed 6 months post challenge follow up visit after receiving a single intramuscular dose of of Placebo on Day -28 and RSV-A Memphis 37b virus on Day 0'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Number of medically attended AEs from vaccination to study end', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Occurrence of SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Number of SAEs from vaccination to study end', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Occurrence of Unsolicited AEs Related to Viral Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 to Day 28', 'description': 'Number of participants with at least one unsolicited AE within 30 days post-viral challenge (Day 0) up to Day +28 follow up. Unsolicited AEs were all AEs for which participants were not specifically questioned in the participant diary.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All vaccinated participants were included in the Safety Analysis Set, irrespective of whether they received challenge virus.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Haematological and Biochemical Laboratory Abnormalities During the Quarantine Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'title': 'Mild raised ALT', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Moderate raised ALT', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Mild raised AST', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Moderate raised AST', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate raised CK', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Mild low platelets', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Mild low lymphocytes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Moderate low neutrophils', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day -2 to Day12', 'description': 'Number of hematological and biochemical laboratory assessment Abnormalities reported as AEs during the quarantine period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Use of Concomitant Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'classes': [{'title': 'Concomitant Medications from Vaccination (Day -28) until Viral Challenge (Day 0)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Concomitant Medications from Viral Challenge (Day 0) until Day 28', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Vaccination (Day -28) until Viral Challenge (Day 0), and From Viral Challenge (Day 0) until Day 28', 'description': 'Concomitant medications (prescription and over the counter drugs and supplements that a study participant had taken alongside the study vaccination) were recorded for the period following vaccination (up to viral challenge) and from viral challenge until Day 28..', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': '70 participants were to be enrolled and vaccinated with the study vaccine, with 62 participants challenged with the study virus.', 'preAssignmentDetails': '70 participants were consented and vaccinated to ensure that 62 were able to then be challenged with RSV-A Memphis 37b accounting for dropouts between vaccination and challenge.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume\n\nRSVPreF: A single dose of 120 mcg RSVpreF for intramuscular injection'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine\n\nPlacebo: A single Placebo dose for intramuscular injection to match experimental vaccine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.0', 'spread': '6.46', 'groupId': 'BG000'}, {'value': '27.1', 'spread': '6.78', 'groupId': 'BG001'}, {'value': '26.5', 'spread': '6.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-22', 'size': 923279, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-05T12:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This is a double blinded, placebo-controlled study'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2021-02-12', 'resultsFirstSubmitDate': '2022-04-05', 'studyFirstSubmitQcDate': '2021-03-04', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-26', 'studyFirstPostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Viral Load-time Curve (VL-AUC) of RSV', 'timeFrame': 'Day 2 to Day 12', 'description': 'The VL-AUC of RSV determined by qRT-PCR from nasal wash samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.'}, {'measure': 'Number of Participants With RT-PCR Confirmed (Detected) Incidence of Symptomatic Infection', 'timeFrame': 'Day 2 to Day 12', 'description': 'RT-PCR-confirmed symptomatic RSV infection defined as:\n\n\\- Two detectable qRT-PCR reported on 2 or more consecutive days (any two detectable (≥LLOD) qRT-PCR measurements reported over 4 consecutive scheduled timepoints).\n\nand\n\n\\- Either one or more positive clinical symptoms from different categories in the symptom scoring system or one Grade 2 symptom from any category'}, {'measure': 'Sum Total Symptoms Diary Card Score (TSS)', 'timeFrame': 'Day 1 to Day 12', 'description': 'The sum total symptoms score is the sum of all scores from the first assessment on Day 1 to the first assessment on Day 12 (34 assessments). Symptom scores were collected three times daily starting one day post-viral challenge (Day +1) up to discharge from quarantine using a participant self-reportable 13-symptoms card. Clinical symptoms include runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptoms from 0 (no symptoms) - 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. For each assessment, an individual total symptom score was derived as the total of the scores given to the 13 symptoms on that symptom score card. Individual total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With RT-PCR Confirmed (Quantifiable) Incidence of Symptomatic Infection', 'timeFrame': 'Day 2 to Day 12', 'description': 'RT-PCR confirmed RSV infection defined as\n\n* Two quantifiable PCR measures reported on 2 or more consecutive days (any two quantifiable (≥LLOQ) qRT-PCR measurements reported over 4 consecutive scheduled timepoints), and\n* Either one or more positive clinical symptoms from different categories in the symptom scoring system or one Grade 2 symptom from any category'}, {'measure': 'Number of Participants With Culture Lab-confirmed Reduction of Symptomatic RSV Infection', 'timeFrame': 'Day 2 to Day 12', 'description': 'Culture lab-confirmed symptomatic RSV infection defined as:\n\n* One quantifiable viral culture and\n* Either one or more positive clinical symptoms from different categories in the symptom scoring system or one Grade 2 symptom from any category'}, {'measure': 'Peak Viral Load of RSV by qRT-PCR', 'timeFrame': 'Day 2 to Day 12', 'description': 'Reduction in Peak viral load of RSV determined by quantifiable qRT-PCR from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.'}, {'measure': 'Peak Viral Load of RSV by Viral Culture', 'timeFrame': 'Day 2 to Day 12', 'description': 'Peak viral load of RSV determined by quantifiable viral culture from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.'}, {'measure': 'Duration of Quantifiable qRT-PCR Measurements', 'timeFrame': 'Day 2 to Day 12', 'description': 'Duration (time in hours) of quantifiable qRT-PCR measurements from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.'}, {'measure': 'Duration of Quantitative Viral Culture Measurements', 'timeFrame': 'Day 2 to Day 12', 'description': 'Duration (time in hours) of quantitative viral culture measurements from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.'}, {'measure': 'VL-AUC Determined by Quantitative Viral Culture', 'timeFrame': 'Day 2 to Day 12', 'description': 'VL-AUC of RSV as determined by quantitative viral culture on nasal samples starting two days post-viral challenge (Day +2) up to discharge from quarantine'}, {'measure': 'Area Under the Curve Over Time of Total Clinical Symptoms (TSS-AUC)', 'timeFrame': 'Day 1 to Day 12', 'description': 'Data presented is hours \\* score. TSS-AUC (trapezium rule) as measured by graded symptom scoring system collected 3 times daily starting Day +1 up to Day 12am using a participant self-reportable 13-symptoms card, the max number of diary cards included in the AUC calculation is 34, the maximum time period is 264hrs.\n\nClinical symptoms included runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptom from 0 (no symptoms) - 3(severe). Shortness of breath and wheeze had an additional scoring option of grade 4. Dairy card total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4).\n\nThe range of TSS AUC scores are between 0 and 10,824 hours\\*score (maximum of 264x41).'}, {'measure': 'Peak Symptoms Diary Card Score', 'timeFrame': 'Day 1 to Day 12', 'description': 'Peak TSS for each participant is defined as the diary card total with the worst score (highest). The symptom scoring system was collected three times daily starting one day post-viral challenge (Day +1) up to discharge from quarantine using a participant self-reportable 13-symptoms card. Clinical symptoms include runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptoms from 0 (no symptoms) - 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. For each assessment, an individual total symptom score was derived as the total of the scores given to the 13 symptoms on that symptom score card. Individual total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4).'}, {'measure': 'Peak Daily Symptom Score', 'timeFrame': 'Day 1 to Day 12', 'description': 'Peak daily symptom score was derived, for each day from Day 1 to Day 12, as the maximum of the 3 total symptoms scores on that day, providing 11 scores each. The symptoms were collected three times daily starting one day post-viral challenge (Day +1) up to discharge from quarantine using a participant self-reportable 13-symptoms card. Clinical symptoms include runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptoms from 0 (no symptoms) - 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. For each assessment, an individual total symptom score was derived as the total of the scores given to the 13 symptoms on that symptom score card. Individual total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4).'}, {'measure': 'Percentage Number of Participants With Grade 2 or Higher Symptoms', 'timeFrame': 'Day 1 to Day 12', 'description': 'Number (%) of participants with Grade 2 or higher symptoms (on any occasion from Day 1 to Day 12)'}, {'measure': 'Number of Participants With an Occurrence of at Least Two Positive Quantifiable qRT-PCR Measurements on 2 or More Consecutive Days', 'timeFrame': 'Day 2 to Day 12', 'description': 'The number of participants with at least two quantifiable positive (≥LLOQ) qRT-PCR nasal sample measurements across 4 consecutive visits'}, {'measure': 'Number of Participants With an Occurrence of at Least Two Positive Detectable qRT-PCR Measurements on 2 or More Consecutive Days', 'timeFrame': 'Day 2 to Day 12', 'description': 'The proportion of participants with at least two positive detectable qRT-PCR nasal sample measurements across 4 consecutive visits'}, {'measure': 'Number of Participants With an Occurrence of at Least One Positive Quantitative Cell Culture Measurements', 'timeFrame': 'Day 2 to Day 12', 'description': 'The proportion of participants with at least one quantifiable positive (≥LLOQ) nasal sample viral culture starting two days post-viral challenge (Day+2) up to discharge from quarantine. Viral culture is only done for samples where qRT-PCR is positive (detectable), when the qRT-PCR is negative the viral culture is assumed to be 0 for any endpoint derivations.'}, {'measure': 'Total Mucus Weight', 'timeFrame': 'Day 1 to Day 12', 'description': 'Total weight of mucus produced starting one day post-viral challenge (Day +1) up to discharge from quarantine.\n\nThe mean sum of all mucus produced from Day 1 to Day 12 is reported in data table.'}, {'measure': 'Total Tissue Number', 'timeFrame': 'Day 1 to Day 12', 'description': 'Total number of tissues used by participants starting one day post-viral challenge (Day +1) up to discharge from quarantine.'}, {'measure': 'Number of Solicited Local Reactions Within 7 Days After Vaccination', 'timeFrame': '7 days post vaccination', 'description': 'Local reactions include pain at injection site, redness and swelling'}, {'measure': 'Number of Systemic Events Within 7 Days After Vaccination', 'timeFrame': '7 days post vaccination', 'description': 'Systemic reactions included fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain. Each of these items was collected on a four-point scale including, none, mild, moderate, and severe.'}, {'measure': 'Number of Participants With an Occurrence of Unsolicited Adverse Events (AEs) Post Vaccination', 'timeFrame': '30 days', 'description': 'Number of participants with at least one unsolicited adverse events (AEs) within 30 days after vaccination. Unsolicited AEs were all AEs for which participants were not specifically questioned in the participant diary.'}, {'measure': 'Occurrence of Medically Attended AEs', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Number of medically attended AEs from vaccination to study end'}, {'measure': 'Occurrence of SAEs', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Number of SAEs from vaccination to study end'}, {'measure': 'Number of Participants With an Occurrence of Unsolicited AEs Related to Viral Challenge', 'timeFrame': 'Day 0 to Day 28', 'description': 'Number of participants with at least one unsolicited AE within 30 days post-viral challenge (Day 0) up to Day +28 follow up. Unsolicited AEs were all AEs for which participants were not specifically questioned in the participant diary.'}, {'measure': 'Occurrence of Haematological and Biochemical Laboratory Abnormalities During the Quarantine Period.', 'timeFrame': 'Day -2 to Day12', 'description': 'Number of hematological and biochemical laboratory assessment Abnormalities reported as AEs during the quarantine period.'}, {'measure': 'Use of Concomitant Medication', 'timeFrame': 'From Vaccination (Day -28) until Viral Challenge (Day 0), and From Viral Challenge (Day 0) until Day 28', 'description': 'Concomitant medications (prescription and over the counter drugs and supplements that a study participant had taken alongside the study vaccination) were recorded for the period following vaccination (up to viral challenge) and from viral challenge until Day 28..'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Syncytial Virus Infections']}, 'referencesModule': {'references': [{'pmid': '35731653', 'type': 'DERIVED', 'citation': 'Schmoele-Thoma B, Zareba AM, Jiang Q, Maddur MS, Danaf R, Mann A, Eze K, Fok-Seang J, Kabir G, Catchpole A, Scott DA, Gurtman AC, Jansen KU, Gruber WC, Dormitzer PR, Swanson KA. Vaccine Efficacy in Adults in a Respiratory Syncytial Virus Challenge Study. N Engl J Med. 2022 Jun 23;386(25):2377-2386. doi: 10.1056/NEJMoa2116154.'}]}, 'descriptionModule': {'briefSummary': 'In this randomised, placebo-controlled, double-blind Phase 2a study, healthy male and female participants 18-50 years of age will be given an investigational RSV vaccine (RSVpreF) and challenged with RSV one month later. The purpose of this research study is to assess the safety, immunogenicity and efficacy of RSVpreF using a human viral challenge model.', 'detailedDescription': 'Respiratory Syncytial Virus (RSV) is a common virus that affects all human age groups and can cause a range of respiratory disease such as bronchitis and lower respiratory infections. These serious illnesses affect infants and adults who are older especially if they are over 65, have chronic heart or lung disease or have a weakened immune system. Vaccination against RSV has the potential to be a highly beneficial and effective approach to reduce RSV disease in older adults and pediatric populations, however there is no current vaccine approved for the prevention of RSV infections.\n\nRSVpreF is being developed to prevent RSV-associated moderate to severe lower respiratory tract disease in adults 60 years of age and in infants by active immunization of pregnant women.\n\nThis study is an exploratory proof-of-concept to assess the safety, immunogenicity and efficacy of RSVpreF using a human challenge model. The RSV challenge model is developed to help understanding the RSV disease and assess new vaccines by testing them in participants deliberately infected with the virus.\n\nIn this study, approximately 62 (up to 72) participants will be vaccinated with the investigational RSVpreF to account for withdrawals between vaccination and challenge. Participants will be randomised 1:1 to receive RSVpreF or placebo.\n\nThe study will consist of a vaccination phase, quarantine phase and a follow-up phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* An informed consent document signed and dated by the participant and the Investigator.\n* Aged between 18 and 50 years.\n* In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety.\n* A documented medical history prior to enrolment.\n* The following criteria are applicable to female participants participating in the study.\n\n 1. Females of childbearing potential must have a negative pregnancy test prior to enrolment.\n 2. Females of non-childbearing potential:\n\n <!-- -->\n\n 1. Post-menopausal females; defined as having a history of amenorrhea for \\>12 months with no alternative medical cause, and /or by FSH level \\>40mIU/mL, confirmed by laboratory.\n 2. Documented status as being surgically sterile (e.g. tubal ligation, hysterectomy, bilateral salpingectomy and bilateral oophorectomy).\n* The following criteria apply to female and male participants:\n\n 1. Female participants of childbearing potential must use one form of highly effective contraception. Hormonal methods must be in place from at least 2 weeks prior to the first study visit. The contraception use must continue until 28 days after the date of viral challenge/last dosing with IMP (whichever occurs last).\n 2. Male participants must agree to the contraceptive requirements below at entry to quarantine and continuing until 28 days after the date of Viral challenge / last dosing with IMP (whichever occurs last): a. Use a condom with a spermicide to prevent pregnancy in a female partner or to prevent exposure of any partner (male and female) to the IMP. b. Male sterilisation with the appropriate post vasectomy documentation of the absence of sperm in the ejaculate (please note that the use of condom with spermicide will still be required to prevent partner exposure). This applies only to males participating in the study. c. In addition, for female partners of child bearing potential, that partner must use another form of contraception such as one of the highly effective methods mentioned above for female participants.\n\n In addition to the contraceptive requirements above, male participants must agree not to donate sperm following discharge from quarantine until 28 days after the date of Viral Challenge/last dosing with IMP (whichever occurs last).\n 3. True abstinence - sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.\n* Sero-suitable to the challenge virus.\n\nExclusion Criteria:\n\n* History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract infection within 4 weeks prior to the first study visit.\n* a) Any history or evidence of any other clinically significant or currently active systemic comorbidities including psychiatric disorders (includes participants with a history of depression and/or anxiety).\n\n b) And/or other major disease that, in the opinion of the Investigator, may put the participant at undue risk, or interfere with a participant completing the study and necessary investigations (e.g autoimmune disease or immunodeficiency).\n* Participants who have smoked ≥ 10 pack years at any time \\[10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years\\].\n* A total body weight ≤ 50 kg and Body Mass Index (BMI) ≤18 kg/m2 and ≥30kg/m2.\n* Females who:\n\n 1. Are breastfeeding, or\n 2. Have been pregnant within 6 months prior to the study.\n* History of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug or vaccine, including hypersensitivity to any of the constituents of the study vaccine, as assessed by the PI.\n* Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.\n* a) Any significant abnormality altering the anatomy of the nose in a substantial way b) Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months c) Any nasal or sinus surgery within 3 months\n* a) Evidence of vaccinations with licensed live attenuated vaccines within the 4 weeks prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first). Evidence of vaccinations with licensed vaccines which are not live attenuated within the 2 weeks prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first).\n\n b) Intention to receive any vaccination(s) before at least 28 days after the viral challenge (NB. No travel restrictions will apply after the Day 28 Follow-up visit).\n* Receipt of blood or blood products, or loss (including blood donations) of 550 mL or more of blood during the 2 months prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first) or planned during the 2 months after the viral challenge.\n* a) Receipt of any investigational drug within 3 months prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first).\n\n b) Previous vaccination with any licensed or investigational RSV vaccine before enrolment into the study. c) Receipt of three or more investigational drugs within the previous 12 months prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first).\n\n d) Prior inoculation with a virus from the same virus-family as the challenge virus.\n\n e) Prior participation in another human viral challenge study with a respiratory virus in the preceding 3 months, taken from the date of viral challenge in the previous study to the date of expected viral challenge in this study.\n\n f) Receipt of treatment with immunosuppressive therapy.\n* a) Confirmed positive test for drugs of abuse and cotinine on first study visit. One repeat test allowed at PI discretion.\n\n b) History or presence of alcohol addiction, or excessive use of alcohol\n* A forced expiratory volume in 1 second (FEV1) \\< 80%.\n* Positive human immunodeficiency virus (HIV), active hepatitis A (HAV), B (HBV), or C (HCV) test.\n* Those employed or immediate relatives of those employed at hVIVO, Pfizer or any vendor.\n* Any other finding that, in the opinion of the Investigator, deems the Participant unsuitable for the study.'}, 'identificationModule': {'nctId': 'NCT04785612', 'briefTitle': 'Study of RSVpreF Vaccination and RSV Challenge in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hvivo'}, 'officialTitle': 'A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Immunogenicity and Efficacy of A Respiratory Syncytial Virus Vaccine (RSVpreF) in A Virus Challenge Model in Healthy Adults', 'orgStudyIdInfo': {'id': 'HVO-CS-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RSVPreF', 'description': 'A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume', 'interventionNames': ['Biological: RSVPreF']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'A single intramuscular injection of Placebo to match active vaccine', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'RSVPreF', 'type': 'BIOLOGICAL', 'description': 'A single dose of 120 mcg RSVpreF for intramuscular injection', 'armGroupLabels': ['RSVPreF']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'A single Placebo dose for intramuscular injection to match experimental vaccine', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1 2AX', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Golam Kabir', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Alex Mann', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hvivo'}, {'name': 'Golam Kabir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hvivo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvivo', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}