Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-29 @ 3:55 PM
Study NCT ID:
NCT03334695
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2017-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Exploratory Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-old Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Medical Leader', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'As no respiratory syncytial virus (RSV) vaccine has been previously tested in a human challenge model, the relationship between the results from this human challenge model and vaccine efficacy against natural infection is unknown.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 6 months post-vaccination and up to 6 months post-challenge', 'description': 'The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.', 'eventGroups': [{'id': 'EG000', 'title': 'Post-dose: Ad26.RSV.preF (1x10^11 vp)', 'description': 'Participants received a single intramuscular injection of 1\\*10\\^11 vp (viral particles) of Ad26.RSV.preF on Day -28.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 4, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Post-dose: Placebo', 'description': 'Participants received a single intramuscular injection of matching placebo on Day -28.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 9, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Post-challenge: Challenge After Ad26.RSV.preF', 'description': 'Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving single intramuscular doses of 1x1011 vp of Ad26.RSV.preF on Day -28.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 16, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Post-challenge: Challenge After Placebo', 'description': 'Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving single intramuscular doses of placebo on Day -28.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 16, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Troponin T Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}], 'seriousEvents': [{'term': 'Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Viral Load-Time Curve (VL-AUC) of Respiratory Syncytial Virus (RSV) by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ad26.RSV.preF (1*10^11 vp)', 'description': 'Participants received a single intramuscular injection of 1\\*10\\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '268.8'}, {'value': '236', 'groupId': 'OG001', 'lowerLimit': '20.3', 'upperLimit': '605.8'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon Rank Sum test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 2 to Day 12', 'description': 'VL-AUC for RSV was determined by qRT-PCR assay of nasal wash samples. Here, values below the lower limit of quantification (LLOQ) were imputed with zero.', 'unitOfMeasure': 'log10 copies*hour per millilitre (h/mL)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants.'}, {'type': 'SECONDARY', 'title': 'Peak Viral Load of RSV-A Memphis 37b', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ad26.RSV.preF (1*10^11 vp)', 'description': 'Participants received a single intramuscular injection of 1\\*10\\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '4.539'}, {'value': '5.365', 'groupId': 'OG001', 'lowerLimit': '3.027', 'upperLimit': '6.665'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 2 to Day 12', 'description': 'Peak viral load of RSV-A Memphis 37b was defined as the maximum viral load as determined by quantitative RT-PCR assay of nasal wash samples. Here, values below the lower limit of quantification (LLOQ) were imputed with zero.', 'unitOfMeasure': 'log10 copies per mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants.'}, {'type': 'SECONDARY', 'title': 'Viral Load by Quantitative RT-PCR Assay on Day 6 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ad26.RSV.preF (1*10^11 vp)', 'description': 'Participants received a single intramuscular injection of 1\\*10\\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}], 'classes': [{'title': 'Day 6: 0 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.821', 'spread': '0.349', 'groupId': 'OG000'}, {'value': '2.898', 'spread': '0.630', 'groupId': 'OG001'}]}]}, {'title': 'Day 6: 12 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.261', 'spread': '0.433', 'groupId': 'OG000'}, {'value': '2.939', 'spread': '0.604', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: 0 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.761', 'spread': '0.436', 'groupId': 'OG000'}, {'value': '3.072', 'spread': '0.586', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: 12 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.552', 'spread': '0.443', 'groupId': 'OG000'}, {'value': '3.025', 'spread': '0.530', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 6 (0 hour and 12 hours) and Day 7 (0 hour and 12 hours)', 'description': 'Viral load determined by quantitative RT-PCR assay of nasal wash samples on Day 6 and Day 7 were reported. Here, values below the lower limit of quantification (LLOQ) were imputed with zero.', 'unitOfMeasure': 'log10 copies per mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants. Here 'n' (number analyzed) signifies the number of participants analyzed for this outcome measure (OM) at specified timepoints."}, {'type': 'SECONDARY', 'title': 'VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ad26.RSV.preF (1*10^11 vp)', 'description': 'Participants received a single intramuscular injection of 1\\*10\\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}], 'classes': [{'title': 'Day 6: 0 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.278', 'spread': '0.1936', 'groupId': 'OG000'}, {'value': '1.587', 'spread': '0.4159', 'groupId': 'OG001'}]}]}, {'title': 'Day 6: 12 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.304', 'spread': '0.2198', 'groupId': 'OG000'}, {'value': '1.737', 'spread': '0.4320', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: 0 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.101', 'spread': '0.1015', 'groupId': 'OG000'}, {'value': '1.226', 'spread': '0.3505', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: 12 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.276', 'spread': '0.1931', 'groupId': 'OG000'}, {'value': '1.237', 'spread': '0.3891', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 6 (0 hour and 12 hours) and Day 7 (0 hour and 12 hours)', 'description': 'VL-AUC of RSV by the quantitative culture of nasal wash samples on Day 6 and Day 7 were determined.\n\npfu\\*h/mL stands for plaque-forming units hour per millilitre.', 'unitOfMeasure': 'log10 pfu*h/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants. Here 'n' (number analyzed) signifies the number of participants analyzed for this OM at specified timepoints."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Symptomatic RSV Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ad26.RSV.preF (1*10^11 vp)', 'description': 'Participants received a single intramuscular injection of 1\\*10\\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}], 'classes': [{'title': 'Conservative', 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000'}, {'value': '46.2', 'groupId': 'OG001'}]}]}, {'title': 'Liberal', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '61.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 2 to Day 12', 'description': 'Symptomatic RSV infection is defined in two ways (Conservative and Liberal). Conservative: participant had 2 or more quantifiable RT-PCR measurements on different samples, with one of following: symptoms of 2 different categories of subject symptom card (SSC) (Upper Respiratory \\[runny/stuffy nose, sneezing, sore throat, earache\\], Lower Respiratory \\[cough, shortness of breath, chest tightness, wheeze\\], Systemic \\[malaise, headache, muscle and/or joint ache\\]) regardless of grade and assessment timepoint or Grade 2 symptom from any category; Liberal (RT-PCR): had 2/more quantifiable RT-PCR measurements, with clinical symptom of any severity.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants.'}, {'type': 'SECONDARY', 'title': 'Total Clinical Symptoms Score at Day 6 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ad26.RSV.preF (1*10^11 vp)', 'description': 'Participants received a single intramuscular injection of 1\\*10\\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}], 'classes': [{'title': 'Day 6: Morning', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Day 6: Afternoon', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Day 6: Evening', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: Morning', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: Afternoon', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: Evening', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 6 and 7: morning, afternoon and evening', 'description': 'The total clinical symptom score was determined as the sum of the scores (grades) ranges from 0 (no symptom) to 52 (severe symptoms) of the 13 self-reportable symptoms on the SSC. Clinical symptoms includes runny nose, stuffy nose, sneezing, sore throat, ear ache, malaise, headache, muscle and/or joint ache, chilliness/ feverishness, cough, chest tightness, shortness of breath and wheeze. For every separate symptom, the score ranges from 0 (I have no symptom) to 4 (its quite bothersome most of the times and stop from participating in activities).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants.'}, {'type': 'SECONDARY', 'title': 'Weight of Mucus Secretions Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ad26.RSV.preF (1*10^11 vp)', 'description': 'Participants received a single intramuscular injection of 1\\*10\\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}], 'classes': [{'title': 'Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.586', 'spread': '0.1883', 'groupId': 'OG000'}, {'value': '0.175', 'spread': '0.0913', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.228', 'spread': '0.0621', 'groupId': 'OG000'}, {'value': '0.086', 'spread': '0.0333', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.997', 'spread': '0.2350', 'groupId': 'OG000'}, {'value': '0.428', 'spread': '0.1459', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.970', 'spread': '0.2176', 'groupId': 'OG000'}, {'value': '0.543', 'spread': '0.1333', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.164', 'spread': '0.3535', 'groupId': 'OG000'}, {'value': '0.714', 'spread': '0.2123', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.440', 'spread': '0.8609', 'groupId': 'OG000'}, {'value': '1.068', 'spread': '0.3539', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.226', 'spread': '0.4925', 'groupId': 'OG000'}, {'value': '3.132', 'spread': '1.0991', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.715', 'spread': '0.7201', 'groupId': 'OG000'}, {'value': '5.124', 'spread': '1.3257', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.799', 'spread': '0.2960', 'groupId': 'OG000'}, {'value': '3.230', 'spread': '1.1022', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.004', 'spread': '0.4147', 'groupId': 'OG000'}, {'value': '1.798', 'spread': '0.4406', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.907', 'spread': '0.3457', 'groupId': 'OG000'}, {'value': '1.785', 'spread': '0.4838', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.749', 'spread': '0.2430', 'groupId': 'OG000'}, {'value': '1.172', 'spread': '0.3442', 'groupId': 'OG001'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.622', 'spread': '0.2647', 'groupId': 'OG000'}, {'value': '0.990', 'spread': '0.3005', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12', 'description': 'The weight mucous over time was determined in grams using eCRF forms. Participants were given pre-weighed packets of paper tissues. After each tissue was used for nose blowing or sneezing, the participants should store them in an airtight plastic bag to calculate the weight of mucus from Day 0 to Day 12. All paper tissues used by each participant were collected for each 24-hour period up to Day 12, to determine daily mucus weight.', 'unitOfMeasure': 'Grams', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants. Here 'n' (number analyzed) signifies the number of participants analyzed for this OM at specified timepoints."}, {'type': 'SECONDARY', 'title': 'Number of Tissues Used Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ad26.RSV.preF (1*10^11 vp)', 'description': 'Participants received a single intramuscular injection of 1\\*10\\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '2.9', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '1.59', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '1.94', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '1.38', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'Day 12', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12', 'description': 'Number of tissues used by participant per time point were reported using eCRF forms. Participants were given pre-weighed packets of paper tissues. After each tissue was used for nose blowing or sneezing, the participants should store them in an airtight plastic bag to calculate the number of tissues used from Day 0 to Day 12. All paper tissues used by each participant were collected for each 24-hour period up to Day 12, to determine daily number of tissues used.', 'unitOfMeasure': 'Tissues', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ad26.RSV.preF (1*10^11 vp)', 'description': 'Participants received a single intramuscular injection of 1\\*10\\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}], 'classes': [{'title': 'Post-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}, {'value': '46.9', 'groupId': 'OG001'}]}]}, {'title': 'Post-challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.1', 'groupId': 'OG000'}, {'value': '69.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days post-vaccination and up to 28 days post-challenge', 'description': 'Unsolicited AEs are all AEs for which participants were specifically not questioned in the participant diary. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Full Analysis Set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' (number analyzed) included all evaluable participants who were analyzed at specified categories."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ad26.RSV.preF (1*10^11 vp)', 'description': 'Participants received a single intramuscular injection of 1\\*10\\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}], 'classes': [{'title': 'Post-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post-challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months post-vaccination and up to 6 months post-challenge', 'description': 'A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Full Analysis Set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' (number analyzed) included all evaluable participants who were analyzed at specified categories."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Solicited Local and Systemic AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ad26.RSV.preF (1*10^11 vp)', 'description': 'Participants received a single intramuscular injection of 1\\*10\\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}], 'classes': [{'title': 'Solicited local AEs', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'Solicited systemic AEs', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days post-vaccination (Day -21)', 'description': 'Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Vital Signs Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ad26.RSV.preF (1*10^11 vp)', 'description': 'Participants received a single intramuscular injection of 1\\*10\\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}], 'classes': [{'title': 'Post-dose: Temperature (<37.5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.5', 'groupId': 'OG000'}, {'value': '93.8', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose: Temperature (37.5-<38.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose: Temperature (38.0-<38.5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose: Temperature (38.5-<39.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose: Bradycardia (pulse): Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose: Bradycardia (pulse): Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose: Bradycardia (pulse): Grade 3/4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose: Hypertension (diastolic): Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose: Hypertension (diastolic): Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose: Hypertension (systolic): Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose: Respiratory rate: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose: Tachycardia (pulse): Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post-challenge: Bradycardia (pulse): Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000'}, {'value': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'Post-challenge: Bradycardia (pulse): Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Post-challenge: Bradycardia (pulse): Grade 3/4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post-challenge: Hypertension (diastolic): Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post-challenge: Hypertension (systolic): Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}, {'title': 'Post-challenge: Respiratory rate: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.9', 'groupId': 'OG000'}, {'value': '26.9', 'groupId': 'OG001'}]}]}, {'title': 'Post-challenge: Tachycardia (pulse): Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 28 post-challenge', 'description': 'Percentage of participants with vital signs abnormalities were reported. Vital signs measurements included body temperature (measured in degree celsius from less than \\[\\<\\] 37.5 to \\<39.5), respiratory rate, systolic and diastolic blood pressure, and pulse rate, which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Full Analysis Set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' (number analyzed) included all evaluable participants who were analyzed at specified categories."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Electrocardiogram (ECG) Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ad26.RSV.preF (1*10^11 vp)', 'description': 'Participants received a single intramuscular injection of 1\\*10\\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}], 'classes': [{'title': 'Heart rate: Abnormally low: Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate: Abnormally low: Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'QTc Bazett (450 millisecond [ms], 480 ms)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'QTc Bazett (increase from baseline [30; 60] ms)', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'QTc Fridericia: (increase from baseline [30; 60] ms)', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 12 post challenge', 'description': 'ECG parameters included heart rate, PR, QRS, QTcB, QTcF, and the uncorrected QT interval which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Laboratory Abnormalities (Graded)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ad26.RSV.preF (1*10^11 vp)', 'description': 'Participants received a single intramuscular injection of 1\\*10\\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}], 'classes': [{'title': 'Post Dose: AA: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose: AP: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose: AsA: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose: AsA: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose: Hyperkalemia: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose: Hypernatremia: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose: Hypoglycemia: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose: Hypophosphatemia:Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose: Hypophosphatemia:Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose: Hemoglobin: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose: Hemoglobin: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose: Neutrophils: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose: WBC increase: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose: Urine Protein: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: AA: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.9', 'groupId': 'OG000'}, {'value': '15.4', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: AA: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: AP: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: AsA: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '15.4', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: AsA: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: AsA: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: Bilirubin: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: Hyperglycemia: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: Hyperkalemia: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: Hypernatremia: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: Hypophosphatemia:Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: Hypoproteinemia:Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: Eosinophils: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: Hemoglobin: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: Neutrophils: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: Platelets: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: Platelets: Grade 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Post Challenge: WBC increase: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 28 post-challenge', 'description': 'Percentage of participants with clinical laboratory abnormalities were reported. The biochemical and hematological parameters analyzed were- Alanine aminotransferase (AA), Alkaline phosphatase (AP), Aspartate aminotransferase (AsP), Hyperkalemia, Hypernatremia, Hypoglycemia, Hypophosphatemia, Hemoglobin, Neutrophils, White blood cell (WBC) - increase and Urine protein, which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Full Analysis Set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' (number analyzed) signifies the number of participants analyzed for this OM at specified categories."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ad26.RSV.preF (1*10^11 vp)', 'description': 'Participants received a single intramuscular injection of 1\\*10\\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'In total, 64 participants were screened. Of these, 63 participants were randomized and received the study vaccine. One participant was randomized in error and did not receive the study vaccine hence not included in the analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ad26.RSV.preF (1*10^11 vp)', 'description': 'Participants received a single intramuscular injection of 1\\*10\\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'spread': '6.19', 'groupId': 'BG000'}, {'value': '25.9', 'spread': '6.56', 'groupId': 'BG001'}, {'value': '25.9', 'spread': '6.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', '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': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'UNITED KINGDOM', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-24', 'size': 1486461, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-01T14:16', 'hasProtocol': True}, {'date': '2018-07-30', 'size': 938365, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-01T14:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'dispFirstSubmitDate': '2019-07-08', 'completionDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2017-10-16', 'dispFirstSubmitQcDate': '2019-07-08', 'resultsFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2017-11-02', 'dispFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-01', 'studyFirstPostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Viral Load-Time Curve (VL-AUC) of Respiratory Syncytial Virus (RSV) by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR)', 'timeFrame': 'From Day 2 to Day 12', 'description': 'VL-AUC for RSV was determined by qRT-PCR assay of nasal wash samples. Here, values below the lower limit of quantification (LLOQ) were imputed with zero.'}], 'secondaryOutcomes': [{'measure': 'Peak Viral Load of RSV-A Memphis 37b', 'timeFrame': 'From Day 2 to Day 12', 'description': 'Peak viral load of RSV-A Memphis 37b was defined as the maximum viral load as determined by quantitative RT-PCR assay of nasal wash samples. Here, values below the lower limit of quantification (LLOQ) were imputed with zero.'}, {'measure': 'Viral Load by Quantitative RT-PCR Assay on Day 6 and 7', 'timeFrame': 'Day 6 (0 hour and 12 hours) and Day 7 (0 hour and 12 hours)', 'description': 'Viral load determined by quantitative RT-PCR assay of nasal wash samples on Day 6 and Day 7 were reported. Here, values below the lower limit of quantification (LLOQ) were imputed with zero.'}, {'measure': 'VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7', 'timeFrame': 'Day 6 (0 hour and 12 hours) and Day 7 (0 hour and 12 hours)', 'description': 'VL-AUC of RSV by the quantitative culture of nasal wash samples on Day 6 and Day 7 were determined.\n\npfu\\*h/mL stands for plaque-forming units hour per millilitre.'}, {'measure': 'Percentage of Participants With Symptomatic RSV Infections', 'timeFrame': 'From Day 2 to Day 12', 'description': 'Symptomatic RSV infection is defined in two ways (Conservative and Liberal). Conservative: participant had 2 or more quantifiable RT-PCR measurements on different samples, with one of following: symptoms of 2 different categories of subject symptom card (SSC) (Upper Respiratory \\[runny/stuffy nose, sneezing, sore throat, earache\\], Lower Respiratory \\[cough, shortness of breath, chest tightness, wheeze\\], Systemic \\[malaise, headache, muscle and/or joint ache\\]) regardless of grade and assessment timepoint or Grade 2 symptom from any category; Liberal (RT-PCR): had 2/more quantifiable RT-PCR measurements, with clinical symptom of any severity.'}, {'measure': 'Total Clinical Symptoms Score at Day 6 and 7', 'timeFrame': 'Day 6 and 7: morning, afternoon and evening', 'description': 'The total clinical symptom score was determined as the sum of the scores (grades) ranges from 0 (no symptom) to 52 (severe symptoms) of the 13 self-reportable symptoms on the SSC. Clinical symptoms includes runny nose, stuffy nose, sneezing, sore throat, ear ache, malaise, headache, muscle and/or joint ache, chilliness/ feverishness, cough, chest tightness, shortness of breath and wheeze. For every separate symptom, the score ranges from 0 (I have no symptom) to 4 (its quite bothersome most of the times and stop from participating in activities).'}, {'measure': 'Weight of Mucus Secretions Over Time', 'timeFrame': 'Day 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12', 'description': 'The weight mucous over time was determined in grams using eCRF forms. Participants were given pre-weighed packets of paper tissues. After each tissue was used for nose blowing or sneezing, the participants should store them in an airtight plastic bag to calculate the weight of mucus from Day 0 to Day 12. All paper tissues used by each participant were collected for each 24-hour period up to Day 12, to determine daily mucus weight.'}, {'measure': 'Number of Tissues Used Over Time', 'timeFrame': 'Day 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12', 'description': 'Number of tissues used by participant per time point were reported using eCRF forms. Participants were given pre-weighed packets of paper tissues. After each tissue was used for nose blowing or sneezing, the participants should store them in an airtight plastic bag to calculate the number of tissues used from Day 0 to Day 12. All paper tissues used by each participant were collected for each 24-hour period up to Day 12, to determine daily number of tissues used.'}, {'measure': 'Percentage of Participants With Unsolicited Adverse Events (AEs)', 'timeFrame': 'Up to 28 days post-vaccination and up to 28 days post-challenge', 'description': 'Unsolicited AEs are all AEs for which participants were specifically not questioned in the participant diary. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.'}, {'measure': 'Percentage of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 6 months post-vaccination and up to 6 months post-challenge', 'description': 'A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.'}, {'measure': 'Percentage of Participants With Solicited Local and Systemic AEs', 'timeFrame': '7 days post-vaccination (Day -21)', 'description': 'Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever.'}, {'measure': 'Percentage of Participants With Vital Signs Abnormalities', 'timeFrame': 'Up to Day 28 post-challenge', 'description': 'Percentage of participants with vital signs abnormalities were reported. Vital signs measurements included body temperature (measured in degree celsius from less than \\[\\<\\] 37.5 to \\<39.5), respiratory rate, systolic and diastolic blood pressure, and pulse rate, which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening).'}, {'measure': 'Percentage of Participants With Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Up to Day 12 post challenge', 'description': 'ECG parameters included heart rate, PR, QRS, QTcB, QTcF, and the uncorrected QT interval which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening).'}, {'measure': 'Percentage of Participants With Clinical Laboratory Abnormalities (Graded)', 'timeFrame': 'Up to Day 28 post-challenge', 'description': 'Percentage of participants with clinical laboratory abnormalities were reported. The biochemical and hematological parameters analyzed were- Alanine aminotransferase (AA), Alkaline phosphatase (AP), Aspartate aminotransferase (AsP), Hyperkalemia, Hypernatremia, Hypoglycemia, Hypophosphatemia, Hemoglobin, Neutrophils, White blood cell (WBC) - increase and Urine protein, which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess a trend for the prophylactic efficacy of a single dose of 1\\*10\\^11 virus particles (vp) of adenovirus serotype 26 respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) administered intramuscularly to adults aged 18-50 years in the respiratory syncytial virus (RSV) challenge model in terms of reduction of nasal wash viral load compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Each participant must sign an Informed Consent Form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, is willing to be isolated and stay in the clinic for the quarantine phase, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol\n* Participants must be in good health, without significant medical illness, on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination (including height and weight), skin examination, medical history, vital signs (systolic and diastolic blood pressure and heart rate, respiratory rate, and body temperature), and the results of clinical laboratory tests performed within 56 days of vaccination. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator\n* Participants must have a non-clinically significant 12-lead electrocardiogram (ECG) within 56 days of vaccination including: normal sinus rhythm (heart rate between 50 and 100 beats per minute \\[bpm\\], extremes included); QT interval corrected for heart rate according to Fridericia (QTcF) interval less than or equal to (\\<=) 450 millisecond (ms); QT interval corrected for heart rate according to Bazett (QTcB) interval \\<= 450 ms; QRS interval less than (\\<) 120 ms; PR interval \\<= 210 ms\n* Participants must be sero-suitable for respiratory syncytial virus (RSV) within 90 days of vaccination (low immunity to the RSV-A Memphis 37b virus using a virus neutralization assay\n* Participant must be healthy on the basis of clinical laboratory tests performed within 56 days of vaccination. If the results of the laboratory screening tests are outside the local laboratory normal reference ranges and additionally within the limits of toxicity Grade 1 according to the US Food and Drug Administration (FDA) toxicity tables (that is, for tests in the FDA table), the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator\n\nExclusion Criteria:\n\n* Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature greater than or equal to (\\>=) 37.8 degree Centigrade within 24 hours prior to study vaccination\n* Participant has history of malignancy (exceptions are basal cell carcinomas of the skin treated over 5 years prior to vaccination considered cured with minimal risk of recurrence)\n* Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively\n\nViral Challenge Exclusion Criteria:\n\n* Participants having donated or lost more than 1 unit of blood (470 milliliter \\[mL\\]) within 60 days or more than one unit of plasma within 7 days\n* Participants with active acute respiratory infection"}, 'identificationModule': {'nctId': 'NCT03334695', 'briefTitle': 'An Exploratory Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-old Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Vaccines & Prevention B.V.'}, 'officialTitle': 'An Exploratory, Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-Old Adults', 'orgStudyIdInfo': {'id': 'CR108398'}, 'secondaryIdInfos': [{'id': '2017-003194-33', 'type': 'EUDRACT_NUMBER'}, {'id': 'VAC18193RSV2002', 'type': 'OTHER', 'domain': 'Janssen Vaccines & Prevention B.V.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Ad26.RSV.preF', 'description': 'Participants will receive single intramuscular injection of 1\\*10\\^11 virus particles (vp) of Ad26.RSV.preF during Day -90 to Day -28. On Day 0, intranasal challenge with respiratory syncytial virus (RSV)-A Memphis 37b virus will occur for all participants.', 'interventionNames': ['Biological: Ad26.RSV.preF']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2: Placebo', 'description': 'Participants will receive single intramuscular injection of placebo as sterile 0.9 percent (%) saline for injection during Day -90 to Day -28. On Day 0, intranasal challenge with RSV-A Memphis 37b virus will occur for all participants.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ad26.RSV.preF', 'type': 'BIOLOGICAL', 'otherNames': ['JNJ-64400141'], 'description': 'Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1\\*10\\^11 vp in single-use vials.', 'armGroupLabels': ['Group 1: Ad26.RSV.preF']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered as sterile 0.9% saline for injection.', 'armGroupLabels': ['Group 2: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1 2AX', 'city': 'London', 'country': 'United Kingdom', 'facility': 'hVIVO Services Limited', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Janssen Vaccines & Prevention B.V. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Vaccines & Prevention B.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Vaccines & Prevention B.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}