Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-02-25 @ 11:07 PM
Study NCT ID:
NCT04138056
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2019-10-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study).', 'description': 'As per the analysis plan, AEs were reported for the RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV60\\_Placebo\\_RSV120(Pooled) \\& dTpa\\_Placebo\\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \\& Extension Study).', 'eventGroups': [{'id': 'EG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 92, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 90, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.', 'otherNumAtRisk': 103, 'deathsNumAtRisk': 103, 'otherNumAffected': 91, 'seriousNumAtRisk': 103, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 82, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 89, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site pain - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 204, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 136, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 200, 'numAffected': 84}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 128, 'numAffected': 60}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 170, 'numAffected': 81}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 86, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 83, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 79, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 69, 'numAffected': 34}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 77, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site erythema - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 18, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 18, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 14, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site swelling - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 16, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 14, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site bruising - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Administration site pain - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Administration site erythema - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pruritus - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Administration site swelling - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site haemorrhage - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaccination site nodule - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site warmth - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Axillary pain - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site induration - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza like illness - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling cold - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hangover - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site discomfort - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site haematoma - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site discolouration - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site rash - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 105, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 101, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 81, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 92, 'numAffected': 42}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 76, 'numAffected': 37}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Disturbance in attention - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sciatica - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Head discomfort - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuralgia - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleep deficit - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-traumatic headache - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorder - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 50, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 60, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 57, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 58, 'numAffected': 29}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 56, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia - Primary Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache - 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Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory tract infection - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal pain - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhoea - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Limb discomfort - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle strain - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Affect lability - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Poor quality sleep - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Night sweats - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear pain - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysmenorrhoea - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vision blurred - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seasonal allergy - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension - Extension Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'title': 'RSVPreF3 (Left Arm), Erythema', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '12.5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '11.3'}, {'value': '5.8', 'groupId': 'OG002', 'lowerLimit': '2.2', 'upperLimit': '12.2'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '2.2', 'upperLimit': '12.4'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '3.7'}]}]}, {'title': 'RSVPreF3 (Left Arm), Pain', 'categories': [{'measurements': [{'value': '51.5', 'groupId': 'OG000', 'lowerLimit': '41.3', 'upperLimit': '61.6'}, {'value': '54', 'groupId': 'OG001', 'lowerLimit': '43.7', 'upperLimit': '64'}, {'value': '52.4', 'groupId': 'OG002', 'lowerLimit': '42.4', 'upperLimit': '62.4'}, {'value': '58.8', 'groupId': 'OG003', 'lowerLimit': '48.6', 'upperLimit': '68.5'}, {'value': '19.2', 'groupId': 'OG004', 'lowerLimit': '12', 'upperLimit': '28.3'}]}]}, {'title': 'RSVPreF3 (Left Arm), Swelling', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '7'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '13.9'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '8.3'}, {'value': '4.9', 'groupId': 'OG003', 'lowerLimit': '1.6', 'upperLimit': '11.1'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '3.7'}]}]}, {'title': 'dTpa (Right Arm), Erythema', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '9.8'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5.4'}, {'value': '4.9', 'groupId': 'OG002', 'lowerLimit': '1.6', 'upperLimit': '11'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '5.3'}, {'value': '6.1', 'groupId': 'OG004', 'lowerLimit': '2.3', 'upperLimit': '12.7'}]}]}, {'title': 'dTpa (Right Arm), Pain', 'categories': [{'measurements': [{'value': '81.2', 'groupId': 'OG000', 'lowerLimit': '72.2', 'upperLimit': '88.3'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '16.9', 'upperLimit': '34.7'}, {'value': '76.7', 'groupId': 'OG002', 'lowerLimit': '67.3', 'upperLimit': '84.5'}, {'value': '18.6', 'groupId': 'OG003', 'lowerLimit': '11.6', 'upperLimit': '27.6'}, {'value': '78.8', 'groupId': 'OG004', 'lowerLimit': '69.4', 'upperLimit': '86.4'}]}]}, {'title': 'dTpa (Right Arm), Swelling', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '11.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3.6'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '6.8'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '5.3'}, {'value': '4', 'groupId': 'OG004', 'lowerLimit': '1.1', 'upperLimit': '10'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 8', 'description': 'Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Solicited Safety Set (SSS) - Primary Study which consisted of all subjects from the Exposed set (ES) - Primary Study for whom solicited safety data were available.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Any Solicited General AEs [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '40.6', 'groupId': 'OG000', 'lowerLimit': '30.9', 'upperLimit': '50.8'}, {'value': '39.6', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '49.8'}, {'value': '37.9', 'groupId': 'OG002', 'lowerLimit': '28.5', 'upperLimit': '48'}, {'value': '32.4', 'groupId': 'OG003', 'lowerLimit': '23.4', 'upperLimit': '42.3'}, {'value': '38.4', 'groupId': 'OG004', 'lowerLimit': '28.8', 'upperLimit': '48.7'}]}]}, {'title': 'Gastrointestinal symptoms', 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000', 'lowerLimit': '15.9', 'upperLimit': '33.3'}, {'value': '28.7', 'groupId': 'OG001', 'lowerLimit': '20.1', 'upperLimit': '38.6'}, {'value': '27.2', 'groupId': 'OG002', 'lowerLimit': '18.9', 'upperLimit': '36.8'}, {'value': '28.4', 'groupId': 'OG003', 'lowerLimit': '19.9', 'upperLimit': '38.2'}, {'value': '28.3', 'groupId': 'OG004', 'lowerLimit': '19.7', 'upperLimit': '38.2'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '44.6', 'groupId': 'OG000', 'lowerLimit': '34.7', 'upperLimit': '54.8'}, {'value': '45.5', 'groupId': 'OG001', 'lowerLimit': '35.6', 'upperLimit': '55.8'}, {'value': '35', 'groupId': 'OG002', 'lowerLimit': '25.8', 'upperLimit': '45'}, {'value': '39.2', 'groupId': 'OG003', 'lowerLimit': '29.7', 'upperLimit': '49.4'}, {'value': '37.4', 'groupId': 'OG004', 'lowerLimit': '27.9', 'upperLimit': '47.7'}]}]}, {'title': 'Temperature', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '7'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '9.8'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '8.3'}, {'value': '3.9', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '9.7'}, {'value': '7.1', 'groupId': 'OG004', 'lowerLimit': '2.9', 'upperLimit': '14'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 8', 'description': 'Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever (body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the SSS - Primary Study which consisted of all subjects from the ES - Primary Study for whom solicited safety data were available.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Any Unsolicited AEs [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}, {'value': '102', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'groupId': 'OG000', 'lowerLimit': '29.1', 'upperLimit': '48.8'}, {'value': '34.7', 'groupId': 'OG001', 'lowerLimit': '25.5', 'upperLimit': '44.8'}, {'value': '33', 'groupId': 'OG002', 'lowerLimit': '24.1', 'upperLimit': '43'}, {'value': '37.3', 'groupId': 'OG003', 'lowerLimit': '27.9', 'upperLimit': '47.4'}, {'value': '32.4', 'groupId': 'OG004', 'lowerLimit': '23.4', 'upperLimit': '42.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 31', 'description': "An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any SAEs [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}, {'value': '102', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 to Day 31', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Any Solicited Local AEs [Extension Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'title': 'Erythema', 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '33.5'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '24.2'}, {'value': '8.7', 'groupId': 'OG002', 'lowerLimit': '2.4', 'upperLimit': '20.8'}, {'value': '14.6', 'groupId': 'OG003', 'lowerLimit': '5.6', 'upperLimit': '29.2'}, {'value': '2.3', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '12'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '87.2', 'groupId': 'OG000', 'lowerLimit': '72.6', 'upperLimit': '95.7'}, {'value': '87.2', 'groupId': 'OG001', 'lowerLimit': '72.6', 'upperLimit': '95.7'}, {'value': '80.4', 'groupId': 'OG002', 'lowerLimit': '66.1', 'upperLimit': '90.6'}, {'value': '85.4', 'groupId': 'OG003', 'lowerLimit': '70.8', 'upperLimit': '94.4'}, {'value': '38.6', 'groupId': 'OG004', 'lowerLimit': '24.4', 'upperLimit': '54.5'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '27.4'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '20.9'}, {'value': '8.7', 'groupId': 'OG002', 'lowerLimit': '2.4', 'upperLimit': '20.8'}, {'value': '4.9', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '16.5'}, {'value': '2.3', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '12'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the Day of 2nd vaccination to Day 8 post 2nd vaccination', 'description': 'Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the SSS - Extension Study which consisted of all subjects from the ES - Extension Study for whom solicited safety data were available.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Any Solicited General AEs [Extension Period]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '42.1'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '19.1', 'upperLimit': '50.2'}, {'value': '37', 'groupId': 'OG002', 'lowerLimit': '23.2', 'upperLimit': '52.5'}, {'value': '46.3', 'groupId': 'OG003', 'lowerLimit': '30.7', 'upperLimit': '62.6'}, {'value': '34.1', 'groupId': 'OG004', 'lowerLimit': '20.5', 'upperLimit': '49.9'}]}]}, {'title': 'Gastrointestinal symptoms', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '24.2'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '36.5'}, {'value': '15.2', 'groupId': 'OG002', 'lowerLimit': '6.3', 'upperLimit': '28.9'}, {'value': '24.4', 'groupId': 'OG003', 'lowerLimit': '12.4', 'upperLimit': '40.3'}, {'value': '13.6', 'groupId': 'OG004', 'lowerLimit': '5.2', 'upperLimit': '27.4'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '44.9'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '19.1', 'upperLimit': '50.2'}, {'value': '32.6', 'groupId': 'OG002', 'lowerLimit': '19.5', 'upperLimit': '48'}, {'value': '56.1', 'groupId': 'OG003', 'lowerLimit': '39.7', 'upperLimit': '71.5'}, {'value': '31.8', 'groupId': 'OG004', 'lowerLimit': '18.6', 'upperLimit': '47.6'}]}]}, {'title': 'Temperature', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.2', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '11.5'}, {'value': '9.8', 'groupId': 'OG003', 'lowerLimit': '2.7', 'upperLimit': '23.1'}, {'value': '2.3', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '12'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the Day of 2nd vaccination to Day 8 post 2nd vaccination', 'description': 'Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever(body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the SSS - Extension Study which consisted of all subjects from the ES - Extension Study for whom solicited safety data were available.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Any Unsolicited AEs [Extension Period]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '34'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '35'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '9', 'upperLimit': '34'}, {'value': '29', 'groupId': 'OG003', 'lowerLimit': '16', 'upperLimit': '46'}, {'value': '20', 'groupId': 'OG004', 'lowerLimit': '9', 'upperLimit': '34'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the Day of 2nd vaccination to Day 31 post 2nd vaccination', 'description': "An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on ES - Extension Study which consisted of all subjects who received at least 2 doses of the study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any SAEs [Extension Period]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the Day of 2nd vaccination to Day 31 post 2nd vaccination', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on ES - Extension Study which consisted of all subjects who received at least 2 doses of the study treatment.'}, {'type': 'PRIMARY', 'title': 'RSV A Neutralizing Antibody Geometric Mean Titers (GMTs) at Screening [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}, {'value': '102', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '875', 'groupId': 'OG000', 'lowerLimit': '745', 'upperLimit': '1027'}, {'value': '1022', 'groupId': 'OG001', 'lowerLimit': '856', 'upperLimit': '1222'}, {'value': '1135', 'groupId': 'OG002', 'lowerLimit': '959', 'upperLimit': '1342'}, {'value': '771', 'groupId': 'OG003', 'lowerLimit': '673', 'upperLimit': '883'}, {'value': '1050', 'groupId': 'OG004', 'lowerLimit': '896', 'upperLimit': '1231'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60 (Estimated Dilution 60).\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': 'Titers (ED60)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Per Protocol Set (PPS) - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'PRIMARY', 'title': 'RSV A Neutralizing Antibody GMTs at Day 8 [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '14166', 'groupId': 'OG000', 'lowerLimit': '12213', 'upperLimit': '16431'}, {'value': '14285', 'groupId': 'OG001', 'lowerLimit': '11999', 'upperLimit': '17008'}, {'value': '10185', 'groupId': 'OG002', 'lowerLimit': '8514', 'upperLimit': '12183'}, {'value': '10590', 'groupId': 'OG003', 'lowerLimit': '8994', 'upperLimit': '12469'}, {'value': '783', 'groupId': 'OG004', 'lowerLimit': '661', 'upperLimit': '929'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 8', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': 'Titers (ED60)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'PRIMARY', 'title': 'RSV A Neutralizing Antibody GMTs at Day 31 [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '9836', 'groupId': 'OG000', 'lowerLimit': '8252', 'upperLimit': '11725'}, {'value': '11038', 'groupId': 'OG001', 'lowerLimit': '9160', 'upperLimit': '13301'}, {'value': '9214', 'groupId': 'OG002', 'lowerLimit': '7806', 'upperLimit': '10876'}, {'value': '8739', 'groupId': 'OG003', 'lowerLimit': '7561', 'upperLimit': '10101'}, {'value': '845', 'groupId': 'OG004', 'lowerLimit': '705', 'upperLimit': '1013'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': 'Titers (ED60)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'PRIMARY', 'title': 'RSV PreF3 IgG Antibody Geometric Mean Concentration (GMCs) at Screening [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}, {'value': '102', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '6611', 'groupId': 'OG000', 'lowerLimit': '5857', 'upperLimit': '7461'}, {'value': '6751', 'groupId': 'OG001', 'lowerLimit': '5982', 'upperLimit': '7620'}, {'value': '7449', 'groupId': 'OG002', 'lowerLimit': '6534', 'upperLimit': '8492'}, {'value': '6172', 'groupId': 'OG003', 'lowerLimit': '5570', 'upperLimit': '6840'}, {'value': '6454', 'groupId': 'OG004', 'lowerLimit': '5771', 'upperLimit': '7217'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA ).\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': 'ELISA Units per milliliter (EU/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'PRIMARY', 'title': 'RSV PreF3 IgG GMCs at Day 8 [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '156568', 'groupId': 'OG000', 'lowerLimit': '137244', 'upperLimit': '178613'}, {'value': '146708', 'groupId': 'OG001', 'lowerLimit': '128639', 'upperLimit': '167315'}, {'value': '101662', 'groupId': 'OG002', 'lowerLimit': '89783', 'upperLimit': '115113'}, {'value': '118670', 'groupId': 'OG003', 'lowerLimit': '106004', 'upperLimit': '132850'}, {'value': '5780', 'groupId': 'OG004', 'lowerLimit': '5145', 'upperLimit': '6494'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 8', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA).\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'PRIMARY', 'title': 'RSV PreF3 IgG GMCs at Day 31 [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '101813', 'groupId': 'OG000', 'lowerLimit': '89290', 'upperLimit': '116092'}, {'value': '106082', 'groupId': 'OG001', 'lowerLimit': '93597', 'upperLimit': '120231'}, {'value': '86273', 'groupId': 'OG002', 'lowerLimit': '77415', 'upperLimit': '96145'}, {'value': '88938', 'groupId': 'OG003', 'lowerLimit': '79738', 'upperLimit': '99200'}, {'value': '6149', 'groupId': 'OG004', 'lowerLimit': '5474', 'upperLimit': '6908'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA).\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}, {'value': '52', 'groupId': 'OG007'}, {'value': '51', 'groupId': 'OG008'}, {'value': '50', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG006', 'title': 'RSV120_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG007', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG008', 'title': 'RSV60_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG009', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'title': 'Left Arm, Erythema', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '16.5'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '14'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '16.2'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10.4'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '7.3'}, {'value': '5.9', 'groupId': 'OG005', 'lowerLimit': '1.2', 'upperLimit': '16.2'}, {'value': '5.9', 'groupId': 'OG006', 'lowerLimit': '1.2', 'upperLimit': '16.2'}, {'value': '5.8', 'groupId': 'OG007', 'lowerLimit': '1.2', 'upperLimit': '15.9'}, {'value': '9.8', 'groupId': 'OG008', 'lowerLimit': '3.3', 'upperLimit': '21.4'}, {'value': '0', 'groupId': 'OG009', 'lowerLimit': '0', 'upperLimit': '7.1'}]}]}, {'title': 'Left Arm, Pain', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '31.8', 'upperLimit': '60.7'}, {'value': '53.1', 'groupId': 'OG001', 'lowerLimit': '38.3', 'upperLimit': '67.5'}, {'value': '52.9', 'groupId': 'OG002', 'lowerLimit': '38.5', 'upperLimit': '67.1'}, {'value': '60.8', 'groupId': 'OG003', 'lowerLimit': '46.1', 'upperLimit': '74.2'}, {'value': '16.3', 'groupId': 'OG004', 'lowerLimit': '7.3', 'upperLimit': '29.7'}, {'value': '56.9', 'groupId': 'OG005', 'lowerLimit': '42.2', 'upperLimit': '70.7'}, {'value': '54.9', 'groupId': 'OG006', 'lowerLimit': '40.3', 'upperLimit': '68.9'}, {'value': '51.9', 'groupId': 'OG007', 'lowerLimit': '37.6', 'upperLimit': '66'}, {'value': '56.9', 'groupId': 'OG008', 'lowerLimit': '42.2', 'upperLimit': '70.7'}, {'value': '22', 'groupId': 'OG009', 'lowerLimit': '11.5', 'upperLimit': '36'}]}]}, {'title': 'Left Arm, Swelling', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '10.6'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '16.9'}, {'value': '3.9', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '13.5'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10.4'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '7.3'}, {'value': '2', 'groupId': 'OG005', 'lowerLimit': '0', 'upperLimit': '10.4'}, {'value': '7.8', 'groupId': 'OG006', 'lowerLimit': '2.2', 'upperLimit': '18.9'}, {'value': '1.9', 'groupId': 'OG007', 'lowerLimit': '0', 'upperLimit': '10.3'}, {'value': '7.8', 'groupId': 'OG008', 'lowerLimit': '2.2', 'upperLimit': '18.9'}, {'value': '0', 'groupId': 'OG009', 'lowerLimit': '0', 'upperLimit': '7.1'}]}]}, {'title': 'Right Arm, Erythema', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '13.7'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '10.9'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10.4'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10.4'}, {'value': '6.1', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '16.9'}, {'value': '3.9', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '13.5'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '7.7', 'groupId': 'OG007', 'lowerLimit': '2.1', 'upperLimit': '18.5'}, {'value': '0', 'groupId': 'OG008', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '6', 'groupId': 'OG009', 'lowerLimit': '1.3', 'upperLimit': '16.5'}]}]}, {'title': 'Right Arm, Pain', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '73.3', 'upperLimit': '94.2'}, {'value': '18.4', 'groupId': 'OG001', 'lowerLimit': '8.8', 'upperLimit': '32'}, {'value': '88.2', 'groupId': 'OG002', 'lowerLimit': '76.1', 'upperLimit': '95.6'}, {'value': '23.5', 'groupId': 'OG003', 'lowerLimit': '12.8', 'upperLimit': '37.5'}, {'value': '79.6', 'groupId': 'OG004', 'lowerLimit': '65.7', 'upperLimit': '89.8'}, {'value': '76.5', 'groupId': 'OG005', 'lowerLimit': '62.5', 'upperLimit': '87.2'}, {'value': '31.4', 'groupId': 'OG006', 'lowerLimit': '19.1', 'upperLimit': '45.9'}, {'value': '65.4', 'groupId': 'OG007', 'lowerLimit': '50.9', 'upperLimit': '78'}, {'value': '13.7', 'groupId': 'OG008', 'lowerLimit': '5.7', 'upperLimit': '26.3'}, {'value': '78', 'groupId': 'OG009', 'lowerLimit': '64', 'upperLimit': '88.5'}]}]}, {'title': 'Right Arm, Swelling', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '16.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7.3'}, {'value': '3.9', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '13.5'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10.4'}, {'value': '6.1', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '16.9'}, {'value': '3.9', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '13.5'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG007', 'lowerLimit': '0', 'upperLimit': '6.8'}, {'value': '0', 'groupId': 'OG008', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2', 'groupId': 'OG009', 'lowerLimit': '0.1', 'upperLimit': '10.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 8', 'description': 'Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the SSS - Primary Study which consisted of all subjects from the ES - Primary Study for whom solicited safety data were available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '52', 'groupId': 'OG007'}, {'value': '51', 'groupId': 'OG008'}, {'value': '50', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG006', 'title': 'RSV120_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG007', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG008', 'title': 'RSV60_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG009', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '22.9', 'upperLimit': '50.8'}, {'value': '36.7', 'groupId': 'OG001', 'lowerLimit': '23.4', 'upperLimit': '51.7'}, {'value': '39.2', 'groupId': 'OG002', 'lowerLimit': '25.8', 'upperLimit': '53.9'}, {'value': '29.4', 'groupId': 'OG003', 'lowerLimit': '17.5', 'upperLimit': '43.8'}, {'value': '34.7', 'groupId': 'OG004', 'lowerLimit': '21.7', 'upperLimit': '49.6'}, {'value': '45.1', 'groupId': 'OG005', 'lowerLimit': '31.1', 'upperLimit': '59.7'}, {'value': '42.3', 'groupId': 'OG006', 'lowerLimit': '28.7', 'upperLimit': '56.8'}, {'value': '36.5', 'groupId': 'OG007', 'lowerLimit': '23.6', 'upperLimit': '51'}, {'value': '35.3', 'groupId': 'OG008', 'lowerLimit': '22.4', 'upperLimit': '49.9'}, {'value': '42', 'groupId': 'OG009', 'lowerLimit': '28.2', 'upperLimit': '56.8'}]}]}, {'title': 'Gastrointestinal symptoms', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '11.5', 'upperLimit': '36'}, {'value': '28.6', 'groupId': 'OG001', 'lowerLimit': '16.6', 'upperLimit': '43.3'}, {'value': '23.5', 'groupId': 'OG002', 'lowerLimit': '12.8', 'upperLimit': '37.5'}, {'value': '29.4', 'groupId': 'OG003', 'lowerLimit': '17.5', 'upperLimit': '43.8'}, {'value': '30.6', 'groupId': 'OG004', 'lowerLimit': '18.3', 'upperLimit': '45.4'}, {'value': '25.5', 'groupId': 'OG005', 'lowerLimit': '14.3', 'upperLimit': '39.6'}, {'value': '28.8', 'groupId': 'OG006', 'lowerLimit': '17.1', 'upperLimit': '43.1'}, {'value': '30.8', 'groupId': 'OG007', 'lowerLimit': '18.7', 'upperLimit': '45.1'}, {'value': '27.5', 'groupId': 'OG008', 'lowerLimit': '15.9', 'upperLimit': '41.7'}, {'value': '26', 'groupId': 'OG009', 'lowerLimit': '14.6', 'upperLimit': '40.3'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '31.8', 'upperLimit': '60.7'}, {'value': '38.8', 'groupId': 'OG001', 'lowerLimit': '25.2', 'upperLimit': '53.8'}, {'value': '31.4', 'groupId': 'OG002', 'lowerLimit': '19.1', 'upperLimit': '45.9'}, {'value': '45.1', 'groupId': 'OG003', 'lowerLimit': '31.1', 'upperLimit': '59.7'}, {'value': '40.8', 'groupId': 'OG004', 'lowerLimit': '27', 'upperLimit': '55.8'}, {'value': '43.1', 'groupId': 'OG005', 'lowerLimit': '29.3', 'upperLimit': '57.8'}, {'value': '51.9', 'groupId': 'OG006', 'lowerLimit': '37.6', 'upperLimit': '66'}, {'value': '38.5', 'groupId': 'OG007', 'lowerLimit': '25.3', 'upperLimit': '53'}, {'value': '33.3', 'groupId': 'OG008', 'lowerLimit': '20.8', 'upperLimit': '47.9'}, {'value': '34', 'groupId': 'OG009', 'lowerLimit': '21.2', 'upperLimit': '48.8'}]}]}, {'title': 'Temperature', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '13.7'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '16.9'}, {'value': '3.9', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '13.5'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '16.2'}, {'value': '12.2', 'groupId': 'OG004', 'lowerLimit': '4.6', 'upperLimit': '24.8'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '1.9', 'groupId': 'OG006', 'lowerLimit': '0', 'upperLimit': '10.3'}, {'value': '1.9', 'groupId': 'OG007', 'lowerLimit': '0', 'upperLimit': '10.3'}, {'value': '2', 'groupId': 'OG008', 'lowerLimit': '0', 'upperLimit': '10.4'}, {'value': '2', 'groupId': 'OG009', 'lowerLimit': '0.1', 'upperLimit': '10.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 8', 'description': 'Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever(body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the SSS - Primary Study which consisted of all subjects from the ES - Primary Study for whom solicited safety data were available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '52', 'groupId': 'OG007'}, {'value': '51', 'groupId': 'OG008'}, {'value': '51', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG006', 'title': 'RSV120_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG007', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG008', 'title': 'RSV60_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG009', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '24.7', 'upperLimit': '52.8'}, {'value': '36.7', 'groupId': 'OG001', 'lowerLimit': '23.4', 'upperLimit': '51.7'}, {'value': '39.2', 'groupId': 'OG002', 'lowerLimit': '25.8', 'upperLimit': '53.9'}, {'value': '43.1', 'groupId': 'OG003', 'lowerLimit': '29.3', 'upperLimit': '57.8'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '20.8', 'upperLimit': '47.9'}, {'value': '39.2', 'groupId': 'OG005', 'lowerLimit': '25.8', 'upperLimit': '53.9'}, {'value': '32.7', 'groupId': 'OG006', 'lowerLimit': '20.3', 'upperLimit': '47.1'}, {'value': '26.9', 'groupId': 'OG007', 'lowerLimit': '15.6', 'upperLimit': '41'}, {'value': '31.4', 'groupId': 'OG008', 'lowerLimit': '19.1', 'upperLimit': '45.9'}, {'value': '31.4', 'groupId': 'OG009', 'lowerLimit': '19.1', 'upperLimit': '45.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 31', 'description': "An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '52', 'groupId': 'OG007'}, {'value': '51', 'groupId': 'OG008'}, {'value': '51', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG006', 'title': 'RSV120_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG007', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG008', 'title': 'RSV60_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG009', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 to Day 31', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any SAEs From 1st Vaccination to Day 181 [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}, {'value': '102', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 to Day 181', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '52', 'groupId': 'OG007'}, {'value': '51', 'groupId': 'OG008'}, {'value': '51', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG006', 'title': 'RSV120_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG007', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG008', 'title': 'RSV60_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG009', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 to Day 181', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any SAEs From 2nd Vaccination to Day 181 Post 2nd Vaccination [Extension Period]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the Day of 2nd vaccination to Day 181 post 2nd vaccination', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on ES - Extension Study which consisted of all subjects who received at least 2 doses of the study treatment.'}, {'type': 'SECONDARY', 'title': 'RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}, {'value': '52', 'groupId': 'OG007'}, {'value': '51', 'groupId': 'OG008'}, {'value': '51', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG006', 'title': 'RSV120_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG007', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG008', 'title': 'RSV60_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG009', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '777', 'groupId': 'OG000', 'lowerLimit': '625', 'upperLimit': '966'}, {'value': '1009', 'groupId': 'OG001', 'lowerLimit': '798', 'upperLimit': '1277'}, {'value': '989', 'groupId': 'OG002', 'lowerLimit': '749', 'upperLimit': '1307'}, {'value': '777', 'groupId': 'OG003', 'lowerLimit': '631', 'upperLimit': '956'}, {'value': '956', 'groupId': 'OG004', 'lowerLimit': '740', 'upperLimit': '1236'}, {'value': '981', 'groupId': 'OG005', 'lowerLimit': '773', 'upperLimit': '1245'}, {'value': '1035', 'groupId': 'OG006', 'lowerLimit': '786', 'upperLimit': '1362'}, {'value': '1298', 'groupId': 'OG007', 'lowerLimit': '1070', 'upperLimit': '1574'}, {'value': '765', 'groupId': 'OG008', 'lowerLimit': '638', 'upperLimit': '917'}, {'value': '1154', 'groupId': 'OG009', 'lowerLimit': '952', 'upperLimit': '1399'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': 'Titers (ED60)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}, {'value': '51', 'groupId': 'OG008'}, {'value': '49', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG006', 'title': 'RSV120_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG007', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG008', 'title': 'RSV60_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG009', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '14523', 'groupId': 'OG000', 'lowerLimit': '11831', 'upperLimit': '17827'}, {'value': '15458', 'groupId': 'OG001', 'lowerLimit': '12424', 'upperLimit': '19231'}, {'value': '10677', 'groupId': 'OG002', 'lowerLimit': '8146', 'upperLimit': '13993'}, {'value': '11128', 'groupId': 'OG003', 'lowerLimit': '8885', 'upperLimit': '13939'}, {'value': '698', 'groupId': 'OG004', 'lowerLimit': '530', 'upperLimit': '918'}, {'value': '13818', 'groupId': 'OG005', 'lowerLimit': '11070', 'upperLimit': '17248'}, {'value': '13264', 'groupId': 'OG006', 'lowerLimit': '10075', 'upperLimit': '17462'}, {'value': '9715', 'groupId': 'OG007', 'lowerLimit': '7612', 'upperLimit': '12400'}, {'value': '10077', 'groupId': 'OG008', 'lowerLimit': '7897', 'upperLimit': '12858'}, {'value': '884', 'groupId': 'OG009', 'lowerLimit': '722', 'upperLimit': '1082'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 8', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': 'Titers (ED60)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '49', 'groupId': 'OG006'}, {'value': '51', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '49', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG006', 'title': 'RSV120_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG007', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG008', 'title': 'RSV60_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG009', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '9838', 'groupId': 'OG000', 'lowerLimit': '7987', 'upperLimit': '12118'}, {'value': '10800', 'groupId': 'OG001', 'lowerLimit': '8675', 'upperLimit': '13446'}, {'value': '8754', 'groupId': 'OG002', 'lowerLimit': '6821', 'upperLimit': '11236'}, {'value': '8141', 'groupId': 'OG003', 'lowerLimit': '6545', 'upperLimit': '10125'}, {'value': '767', 'groupId': 'OG004', 'lowerLimit': '575', 'upperLimit': '1023'}, {'value': '9834', 'groupId': 'OG005', 'lowerLimit': '7354', 'upperLimit': '13152'}, {'value': '11276', 'groupId': 'OG006', 'lowerLimit': '8283', 'upperLimit': '15351'}, {'value': '9698', 'groupId': 'OG007', 'lowerLimit': '7735', 'upperLimit': '12159'}, {'value': '9395', 'groupId': 'OG008', 'lowerLimit': '7726', 'upperLimit': '11425'}, {'value': '930', 'groupId': 'OG009', 'lowerLimit': '740', 'upperLimit': '1168'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': 'Titers (ED60)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG006', 'title': 'RSV120_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG007', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG008', 'title': 'RSV60_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG009', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '2034', 'groupId': 'OG000', 'lowerLimit': '1458', 'upperLimit': '2836'}, {'value': '2869', 'groupId': 'OG001', 'lowerLimit': '1998', 'upperLimit': '4119'}, {'value': '3086', 'groupId': 'OG002', 'lowerLimit': '2143', 'upperLimit': '4445'}, {'value': '2200', 'groupId': 'OG003', 'lowerLimit': '1522', 'upperLimit': '3180'}, {'value': '675', 'groupId': 'OG004', 'lowerLimit': '495', 'upperLimit': '920'}, {'value': '2014', 'groupId': 'OG005', 'lowerLimit': '1190', 'upperLimit': '3411'}, {'value': '2960', 'groupId': 'OG006', 'lowerLimit': '1190', 'upperLimit': '7362'}, {'value': '2474', 'groupId': 'OG007', 'lowerLimit': '1741', 'upperLimit': '3517'}, {'value': '2569', 'groupId': 'OG008', 'lowerLimit': '1586', 'upperLimit': '4160'}, {'value': '969', 'groupId': 'OG009', 'lowerLimit': '602', 'upperLimit': '1560'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At a single timepoint between 12 to 18 months post 1st vaccination', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': 'Titers (ED60)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '2027', 'groupId': 'OG000', 'lowerLimit': '1546', 'upperLimit': '2656'}, {'value': '2889', 'groupId': 'OG001', 'lowerLimit': '2086', 'upperLimit': '4001'}, {'value': '2885', 'groupId': 'OG002', 'lowerLimit': '2204', 'upperLimit': '3778'}, {'value': '2302', 'groupId': 'OG003', 'lowerLimit': '1730', 'upperLimit': '3064'}, {'value': '759', 'groupId': 'OG004', 'lowerLimit': '588', 'upperLimit': '980'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At a single timepoint between 12 to 18 months post 1st vaccination', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': 'Titers (ED60)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'RSV A Neutralizing GMTs at Day 31 Post 2nd Vaccination [Extension Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '3892', 'groupId': 'OG000', 'lowerLimit': '3016', 'upperLimit': '5022'}, {'value': '5071', 'groupId': 'OG001', 'lowerLimit': '3848', 'upperLimit': '6683'}, {'value': '4779', 'groupId': 'OG002', 'lowerLimit': '3747', 'upperLimit': '6094'}, {'value': '4920', 'groupId': 'OG003', 'lowerLimit': '3886', 'upperLimit': '6231'}, {'value': '8200', 'groupId': 'OG004', 'lowerLimit': '6380', 'upperLimit': '10539'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 31 post 2nd vaccination', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': 'Titers (ED60)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Extension Study which consisted of all subjects from the ES - Extension Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}, {'value': '52', 'groupId': 'OG007'}, {'value': '51', 'groupId': 'OG008'}, {'value': '51', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG006', 'title': 'RSV120_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG007', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG008', 'title': 'RSV60_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG009', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '6240', 'groupId': 'OG000', 'lowerLimit': '5159', 'upperLimit': '7548'}, {'value': '6524', 'groupId': 'OG001', 'lowerLimit': '5597', 'upperLimit': '7604'}, {'value': '7237', 'groupId': 'OG002', 'lowerLimit': '5905', 'upperLimit': '8869'}, {'value': '6106', 'groupId': 'OG003', 'lowerLimit': '5275', 'upperLimit': '7067'}, {'value': '5907', 'groupId': 'OG004', 'lowerLimit': '5077', 'upperLimit': '6873'}, {'value': '6987', 'groupId': 'OG005', 'lowerLimit': '5975', 'upperLimit': '8170'}, {'value': '6978', 'groupId': 'OG006', 'lowerLimit': '5764', 'upperLimit': '8447'}, {'value': '7662', 'groupId': 'OG007', 'lowerLimit': '6447', 'upperLimit': '9107'}, {'value': '6240', 'groupId': 'OG008', 'lowerLimit': '5375', 'upperLimit': '7245'}, {'value': '7051', 'groupId': 'OG009', 'lowerLimit': '5973', 'upperLimit': '8324'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '50', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}, {'value': '51', 'groupId': 'OG008'}, {'value': '49', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG006', 'title': 'RSV120_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG007', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG008', 'title': 'RSV60_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG009', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '155721', 'groupId': 'OG000', 'lowerLimit': '133435', 'upperLimit': '181728'}, {'value': '143104', 'groupId': 'OG001', 'lowerLimit': '126138', 'upperLimit': '162352'}, {'value': '100064', 'groupId': 'OG002', 'lowerLimit': '84699', 'upperLimit': '118216'}, {'value': '123475', 'groupId': 'OG003', 'lowerLimit': '107405', 'upperLimit': '141950'}, {'value': '5523', 'groupId': 'OG004', 'lowerLimit': '4700', 'upperLimit': '6490'}, {'value': '157403', 'groupId': 'OG005', 'lowerLimit': '126554', 'upperLimit': '195772'}, {'value': '150184', 'groupId': 'OG006', 'lowerLimit': '119250', 'upperLimit': '189142'}, {'value': '103286', 'groupId': 'OG007', 'lowerLimit': '85400', 'upperLimit': '124919'}, {'value': '114053', 'groupId': 'OG008', 'lowerLimit': '95089', 'upperLimit': '136799'}, {'value': '6061', 'groupId': 'OG009', 'lowerLimit': '5097', 'upperLimit': '7207'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 8', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the Boostrix (300 μg or 500 μg of aluminum). The objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of Boostrix formulation on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '49', 'groupId': 'OG006'}, {'value': '51', 'groupId': 'OG007'}, {'value': '49', 'groupId': 'OG008'}, {'value': '49', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG006', 'title': 'RSV120_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG007', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG008', 'title': 'RSV60_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG009', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '94254', 'groupId': 'OG000', 'lowerLimit': '80742', 'upperLimit': '110026'}, {'value': '95113', 'groupId': 'OG001', 'lowerLimit': '83282', 'upperLimit': '108624'}, {'value': '84509', 'groupId': 'OG002', 'lowerLimit': '72281', 'upperLimit': '98805'}, {'value': '81915', 'groupId': 'OG003', 'lowerLimit': '70291', 'upperLimit': '95460'}, {'value': '5600', 'groupId': 'OG004', 'lowerLimit': '4777', 'upperLimit': '6565'}, {'value': '109978', 'groupId': 'OG005', 'lowerLimit': '88643', 'upperLimit': '136446'}, {'value': '118052', 'groupId': 'OG006', 'lowerLimit': '95525', 'upperLimit': '145892'}, {'value': '88075', 'groupId': 'OG007', 'lowerLimit': '75406', 'upperLimit': '102872'}, {'value': '96727', 'groupId': 'OG008', 'lowerLimit': '82608', 'upperLimit': '113258'}, {'value': '6739', 'groupId': 'OG009', 'lowerLimit': '5678', 'upperLimit': '7999'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG006', 'title': 'RSV120_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG007', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG008', 'title': 'RSV60_Placebo_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG009', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '18832', 'groupId': 'OG000', 'lowerLimit': '15141', 'upperLimit': '23423'}, {'value': '20894', 'groupId': 'OG001', 'lowerLimit': '16466', 'upperLimit': '26512'}, {'value': '23189', 'groupId': 'OG002', 'lowerLimit': '18629', 'upperLimit': '28864'}, {'value': '20720', 'groupId': 'OG003', 'lowerLimit': '16689', 'upperLimit': '25726'}, {'value': '5014', 'groupId': 'OG004', 'lowerLimit': '3932', 'upperLimit': '6392'}, {'value': '18127', 'groupId': 'OG005', 'lowerLimit': '10969', 'upperLimit': '29958'}, {'value': '19641', 'groupId': 'OG006', 'lowerLimit': '9143', 'upperLimit': '42195'}, {'value': '22905', 'groupId': 'OG007', 'lowerLimit': '17801', 'upperLimit': '29471'}, {'value': '22233', 'groupId': 'OG008', 'lowerLimit': '15931', 'upperLimit': '31029'}, {'value': '6811', 'groupId': 'OG009', 'lowerLimit': '5005', 'upperLimit': '9269'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At a single timepoint between 12 to 18 months post 1st vaccination', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the Boostrix (300 μg or 500 μg of aluminum). The objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of Boostrix formulation on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '18570', 'groupId': 'OG000', 'lowerLimit': '14961', 'upperLimit': '23049'}, {'value': '20605', 'groupId': 'OG001', 'lowerLimit': '16333', 'upperLimit': '25995'}, {'value': '23102', 'groupId': 'OG002', 'lowerLimit': '19586', 'upperLimit': '27249'}, {'value': '21152', 'groupId': 'OG003', 'lowerLimit': '17777', 'upperLimit': '25168'}, {'value': '5540', 'groupId': 'OG004', 'lowerLimit': '4581', 'upperLimit': '6700'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At a single timepoint between 12 to 18 months post 1st vaccination', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL.\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'RSV PreF3 IgG GMCs at Day 31 Post 2nd Vaccination [Extension Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '41399', 'groupId': 'OG000', 'lowerLimit': '34806', 'upperLimit': '49241'}, {'value': '42943', 'groupId': 'OG001', 'lowerLimit': '37226', 'upperLimit': '49537'}, {'value': '43977', 'groupId': 'OG002', 'lowerLimit': '38784', 'upperLimit': '49865'}, {'value': '45680', 'groupId': 'OG003', 'lowerLimit': '38574', 'upperLimit': '54094'}, {'value': '86934', 'groupId': 'OG004', 'lowerLimit': '75442', 'upperLimit': '100177'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 31 post 2nd vaccination', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.', 'unitOfMeasure': '(IU/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Extension Study which consisted of all subjects from the ES - Extension Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'title': 'anti-PT', 'categories': [{'measurements': [{'value': '7.39', 'groupId': 'OG000', 'lowerLimit': '5.11', 'upperLimit': '10.68'}, {'value': '7.64', 'groupId': 'OG001', 'lowerLimit': '5.47', 'upperLimit': '10.66'}, {'value': '6.65', 'groupId': 'OG002', 'lowerLimit': '4.66', 'upperLimit': '9.47'}, {'value': '7.55', 'groupId': 'OG003', 'lowerLimit': '5.34', 'upperLimit': '10.66'}, {'value': '5.66', 'groupId': 'OG004', 'lowerLimit': '4.06', 'upperLimit': '7.88'}, {'value': '7.17', 'groupId': 'OG005', 'lowerLimit': '4.94', 'upperLimit': '10.41'}]}]}, {'title': 'anti-FHA', 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '46.7'}, {'value': '34.5', 'groupId': 'OG001', 'lowerLimit': '24.3', 'upperLimit': '49.1'}, {'value': '29.3', 'groupId': 'OG002', 'lowerLimit': '22', 'upperLimit': '38.9'}, {'value': '31', 'groupId': 'OG003', 'lowerLimit': '22.7', 'upperLimit': '42.4'}, {'value': '29.6', 'groupId': 'OG004', 'lowerLimit': '22.5', 'upperLimit': '38.9'}, {'value': '28', 'groupId': 'OG005', 'lowerLimit': '21', 'upperLimit': '37.4'}]}]}, {'title': 'anti-PRN', 'categories': [{'measurements': [{'value': '43.2', 'groupId': 'OG000', 'lowerLimit': '27.9', 'upperLimit': '66.7'}, {'value': '39', 'groupId': 'OG001', 'lowerLimit': '25.3', 'upperLimit': '60.1'}, {'value': '28.1', 'groupId': 'OG002', 'lowerLimit': '18.2', 'upperLimit': '43.4'}, {'value': '42.1', 'groupId': 'OG003', 'lowerLimit': '27.6', 'upperLimit': '64.2'}, {'value': '40.1', 'groupId': 'OG004', 'lowerLimit': '26.9', 'upperLimit': '60'}, {'value': '28.7', 'groupId': 'OG005', 'lowerLimit': '17.9', 'upperLimit': '46.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).', 'unitOfMeasure': 'International Units Per mL (IU/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'title': 'anti-PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '57.36', 'groupId': 'OG000', 'lowerLimit': '41.82', 'upperLimit': '78.69'}, {'value': '54.95', 'groupId': 'OG001', 'lowerLimit': '44.78', 'upperLimit': '67.44'}, {'value': '79.16', 'groupId': 'OG002', 'lowerLimit': '62.67', 'upperLimit': '99.98'}, {'value': '43.76', 'groupId': 'OG003', 'lowerLimit': '34.1', 'upperLimit': '56.17'}, {'value': '36.98', 'groupId': 'OG004', 'lowerLimit': '28.25', 'upperLimit': '48.42'}, {'value': '44.99', 'groupId': 'OG005', 'lowerLimit': '34.81', 'upperLimit': '58.15'}]}]}, {'title': 'anti-FHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '237.1', 'groupId': 'OG000', 'lowerLimit': '194.1', 'upperLimit': '289.5'}, {'value': '210.6', 'groupId': 'OG001', 'lowerLimit': '168.5', 'upperLimit': '263.1'}, {'value': '303.6', 'groupId': 'OG002', 'lowerLimit': '241.6', 'upperLimit': '381.5'}, {'value': '186.5', 'groupId': 'OG003', 'lowerLimit': '149.8', 'upperLimit': '232.3'}, {'value': '176.7', 'groupId': 'OG004', 'lowerLimit': '139.3', 'upperLimit': '224.1'}, {'value': '232.9', 'groupId': 'OG005', 'lowerLimit': '182.2', 'upperLimit': '297.8'}]}]}, {'title': 'anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '309.5', 'groupId': 'OG000', 'lowerLimit': '226.7', 'upperLimit': '422.6'}, {'value': '214.7', 'groupId': 'OG001', 'lowerLimit': '166.8', 'upperLimit': '276.4'}, {'value': '395.1', 'groupId': 'OG002', 'lowerLimit': '290.3', 'upperLimit': '537.6'}, {'value': '217.7', 'groupId': 'OG003', 'lowerLimit': '153.7', 'upperLimit': '308.3'}, {'value': '228.1', 'groupId': 'OG004', 'lowerLimit': '161.9', 'upperLimit': '321.5'}, {'value': '331.4', 'groupId': 'OG005', 'lowerLimit': '238.4', 'upperLimit': '460.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).', 'unitOfMeasure': '(IU/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'Diphtheria (Anti-D) GMC at Screening by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '50', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '0.39'}, {'value': '0.27', 'groupId': 'OG001', 'lowerLimit': '0.17', 'upperLimit': '0.42'}, {'value': '0.23', 'groupId': 'OG002', 'lowerLimit': '0.16', 'upperLimit': '0.32'}, {'value': '0.46', 'groupId': 'OG003', 'lowerLimit': '0.33', 'upperLimit': '0.64'}, {'value': '0.55', 'groupId': 'OG004', 'lowerLimit': '0.42', 'upperLimit': '0.73'}, {'value': '0.58', 'groupId': 'OG005', 'lowerLimit': '0.43', 'upperLimit': '0.78'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).', 'unitOfMeasure': '(IU/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'Diphtheria (Anti-D) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.97', 'upperLimit': '1.73'}, {'value': '1.18', 'groupId': 'OG001', 'lowerLimit': '0.85', 'upperLimit': '1.63'}, {'value': '1.76', 'groupId': 'OG002', 'lowerLimit': '1.25', 'upperLimit': '2.48'}, {'value': '2.11', 'groupId': 'OG003', 'lowerLimit': '1.61', 'upperLimit': '2.76'}, {'value': '2.2', 'groupId': 'OG004', 'lowerLimit': '1.72', 'upperLimit': '2.81'}, {'value': '3.29', 'groupId': 'OG005', 'lowerLimit': '2.62', 'upperLimit': '4.14'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).', 'unitOfMeasure': '(IU/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'Tetanus (Anti-T) GMCs at Screening by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.14', 'groupId': 'OG000', 'lowerLimit': '0.87', 'upperLimit': '1.5'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.78', 'upperLimit': '1.54'}, {'value': '0.88', 'groupId': 'OG002', 'lowerLimit': '0.64', 'upperLimit': '1.22'}, {'value': '1.35', 'groupId': 'OG003', 'lowerLimit': '1.01', 'upperLimit': '1.81'}, {'value': '1.56', 'groupId': 'OG004', 'lowerLimit': '1.27', 'upperLimit': '1.92'}, {'value': '1.68', 'groupId': 'OG005', 'lowerLimit': '1.29', 'upperLimit': '2.19'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).', 'unitOfMeasure': '(IU/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'Tetanus (Anti-T) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV60_dTpa_RSV120(EX-US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'dTpa_Placebo_RSV120(EX-US)', 'description': 'Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG003', 'title': 'RSV120_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG004', 'title': 'RSV60_dTpa_RSV120(US)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG005', 'title': 'dTpa_Placebo_RSV120(US)', 'description': 'Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.57', 'groupId': 'OG000', 'lowerLimit': '4.64', 'upperLimit': '6.7'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '4.52', 'upperLimit': '6.21'}, {'value': '6.74', 'groupId': 'OG002', 'lowerLimit': '5.79', 'upperLimit': '7.84'}, {'value': '6.09', 'groupId': 'OG003', 'lowerLimit': '4.98', 'upperLimit': '7.45'}, {'value': '6.27', 'groupId': 'OG004', 'lowerLimit': '5.29', 'upperLimit': '7.44'}, {'value': '8.32', 'groupId': 'OG005', 'lowerLimit': '6.88', 'upperLimit': '10.05'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).', 'unitOfMeasure': '(IU/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'title': 'Anti-PT', 'categories': [{'measurements': [{'value': '7.47', 'groupId': 'OG000', 'lowerLimit': '5.83', 'upperLimit': '9.57'}, {'value': '6.56', 'groupId': 'OG001', 'lowerLimit': '5.20', 'upperLimit': '8.28'}, {'value': '6.90', 'groupId': 'OG002', 'lowerLimit': '5.36', 'upperLimit': '8.89'}]}]}, {'title': 'Anti-FHA', 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000', 'lowerLimit': '25.3', 'upperLimit': '40.2'}, {'value': '31.9', 'groupId': 'OG001', 'lowerLimit': '25.6', 'upperLimit': '39.8'}, {'value': '28.6', 'groupId': 'OG002', 'lowerLimit': '23.5', 'upperLimit': '34.9'}]}]}, {'title': 'Anti-PRN', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000', 'lowerLimit': '31.6', 'upperLimit': '57.4'}, {'value': '39.6', 'groupId': 'OG001', 'lowerLimit': '29.6', 'upperLimit': '52.9'}, {'value': '28.4', 'groupId': 'OG002', 'lowerLimit': '20.7', 'upperLimit': '38.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA.\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'title': 'Anti-PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50.10', 'groupId': 'OG000', 'lowerLimit': '41.04', 'upperLimit': '61.17'}, {'value': '45.08', 'groupId': 'OG001', 'lowerLimit': '38.00', 'upperLimit': '53.48'}, {'value': '59.51', 'groupId': 'OG002', 'lowerLimit': '49.71', 'upperLimit': '71.23'}]}]}, {'title': 'Anti-FHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '210.3', 'groupId': 'OG000', 'lowerLimit': '181.4', 'upperLimit': '243.8'}, {'value': '192.9', 'groupId': 'OG001', 'lowerLimit': '164.2', 'upperLimit': '226.6'}, {'value': '265.6', 'groupId': 'OG002', 'lowerLimit': '224.7', 'upperLimit': '313.8'}]}]}, {'title': 'Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '259.6', 'groupId': 'OG000', 'lowerLimit': '205.8', 'upperLimit': '327.4'}, {'value': '221.3', 'groupId': 'OG001', 'lowerLimit': '179.5', 'upperLimit': '272.9'}, {'value': '361.1', 'groupId': 'OG002', 'lowerLimit': '289.1', 'upperLimit': '451.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA.\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'Diphtheria (Anti-D) GMCs at Screening [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000', 'lowerLimit': '0.27', 'upperLimit': '0.45'}, {'value': '0.39', 'groupId': 'OG001', 'lowerLimit': '0.30', 'upperLimit': '0.51'}, {'value': '0.36', 'groupId': 'OG002', 'lowerLimit': '0.28', 'upperLimit': '0.47'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA.\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'Diphtheria (Anti-D) GMCs at Day 31 [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.65', 'groupId': 'OG000', 'lowerLimit': '1.35', 'upperLimit': '2.01'}, {'value': '1.59', 'groupId': 'OG001', 'lowerLimit': '1.29', 'upperLimit': '1.97'}, {'value': '2.42', 'groupId': 'OG002', 'lowerLimit': '1.96', 'upperLimit': '2.99'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA.\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'Tetanus (Anti-T) GMCs at Screening [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.24', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '1.51'}, {'value': '1.31', 'groupId': 'OG001', 'lowerLimit': '1.08', 'upperLimit': '1.60'}, {'value': '1.22', 'groupId': 'OG002', 'lowerLimit': '0.98', 'upperLimit': '1.51'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA.\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}, {'type': 'SECONDARY', 'title': 'Tetanus (Anti-T) GMCs at Day 31 [Primary Study]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG001', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'OG002', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.83', 'groupId': 'OG000', 'lowerLimit': '5.10', 'upperLimit': '6.66'}, {'value': '5.76', 'groupId': 'OG001', 'lowerLimit': '5.13', 'upperLimit': '6.47'}, {'value': '7.49', 'groupId': 'OG002', 'lowerLimit': '6.64', 'upperLimit': '8.46'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA.\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'FG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'FG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'FG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'FG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}], 'periods': [{'title': 'Primary Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '101'}, {'groupId': 'FG002', 'numSubjects': '103'}, {'groupId': 'FG003', 'numSubjects': '102'}, {'groupId': 'FG004', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '100'}, {'groupId': 'FG003', 'numSubjects': '100'}, {'groupId': 'FG004', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'ELIGIBILITY CRITERIA NOT FULFILLED (INCLUSION AND EXCLUSION CRITERIA)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Extension Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Out of 95 subjects who completed the Primary Study, 56 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).', 'groupId': 'FG000', 'numSubjects': '39'}, {'comment': 'Out of 93 subjects, who completed the Primary Study, 52 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).', 'groupId': 'FG001', 'numSubjects': '41'}, {'comment': 'Out of 100 subjects, who completed the Primary Study, 54 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).', 'groupId': 'FG002', 'numSubjects': '46'}, {'comment': 'Out of 100 subjects, who completed the Primary Study, 59 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).', 'groupId': 'FG003', 'numSubjects': '41'}, {'comment': 'Out of 98 subjects, who completed the Primary Study, 52 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).', 'groupId': 'FG004', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '41'}, {'groupId': 'FG004', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Data reported in the participant flow, baseline characteristics and the immunogenicity outcome measures of the Extension Study were only analyzed for pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) \\& dTpa\\_Placebo\\_RSV120(Pooled)\\], as the two formulations of dTpa vaccine (containing 300 micrograms(μg) or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}, {'value': '509', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'BG001', 'title': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'BG002', 'title': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'BG003', 'title': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'BG004', 'title': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}, {'value': '509', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '31.4', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '31.0', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '30.8', 'spread': '8.4', 'groupId': 'BG002'}, {'value': '30.5', 'spread': '8.3', 'groupId': 'BG003'}, {'value': '30.4', 'spread': '7.9', 'groupId': 'BG004'}, {'value': '30.8', 'spread': '8.0', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Age, Primary Study', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '213', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '32.1', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '31.7', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '30.4', 'spread': '8.6', 'groupId': 'BG002'}, {'value': '30.3', 'spread': '8.4', 'groupId': 'BG003'}, {'value': '32.6', 'spread': '8.2', 'groupId': 'BG004'}, {'value': '31.4', 'spread': '8.3', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Age, Extension Study'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}, {'value': '509', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}, {'value': '509', 'groupId': 'BG005'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}, {'value': '509', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Sex/Gender, Primary Study', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '213', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '213', 'groupId': 'BG005'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '213', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Sex/Gender, Extension Study'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'AMERICAN INDIAN OR ALASKA NATIVE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}, {'value': '509', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}]}, {'title': 'ASIAN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}, {'value': '509', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}]}]}, {'title': 'BLACK OR AFRICAN AMERICAN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}, {'value': '509', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}]}, {'title': 'OTHER Not specified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}, {'value': '509', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}]}, {'title': 'WHITE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}, {'value': '509', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}, {'value': '454', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race/Ethnicity, Primary Study', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'AMERICAN INDIAN OR ALASKA NATIVE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '213', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'ASIAN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '213', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}, {'title': 'BLACK OR AFRICAN AMERICAN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '213', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}, {'title': 'OTHER Not specified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '213', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}, {'title': 'WHITE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '213', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '202', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race/Ethnicity, Extension Study'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-14', 'size': 2243585, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-18T07:28', 'hasProtocol': True}, {'date': '2020-12-03', 'size': 2078132, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-18T07:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Data will be collected in an observer-blind manner. In an observer-blind study, the subject and the site and sponsor personnel involved in the clinical evaluation of the subjects are blinded while other study personnel may be aware of the treatment assignment. By observer-blind, it is meant that during the course of the study, the vaccine(s) recipient and those responsible for the evaluation of any study endpoint (e.g. safety, reactogenicity) will all be unaware of which vaccines were administered.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 509}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'dispFirstSubmitDate': '2021-01-28', 'completionDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2019-10-22', 'dispFirstSubmitQcDate': '2021-02-08', 'resultsFirstSubmitDate': '2022-11-18', 'studyFirstSubmitQcDate': '2019-10-22', 'dispFirstPostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-18', 'studyFirstPostDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study]', 'timeFrame': 'From Day 1 to Day 8', 'description': 'Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.'}, {'measure': 'Percentage of Subjects With Any Solicited General AEs [Primary Study]', 'timeFrame': 'From Day 1 to Day 8', 'description': 'Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever (body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.'}, {'measure': 'Percentage of Subjects With Any Unsolicited AEs [Primary Study]', 'timeFrame': 'From Day 1 to Day 31', 'description': "An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3."}, {'measure': 'Number of Subjects With Any SAEs [Primary Study]', 'timeFrame': 'From Day 1 to Day 31', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.'}, {'measure': 'Percentage of Subjects With Any Solicited Local AEs [Extension Study]', 'timeFrame': 'From the Day of 2nd vaccination to Day 8 post 2nd vaccination', 'description': 'Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.'}, {'measure': 'Percentage of Subjects Any Solicited General AEs [Extension Period]', 'timeFrame': 'From the Day of 2nd vaccination to Day 8 post 2nd vaccination', 'description': 'Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever(body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.'}, {'measure': 'Percentage of Subjects With Any Unsolicited AEs [Extension Period]', 'timeFrame': 'From the Day of 2nd vaccination to Day 31 post 2nd vaccination', 'description': "An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3."}, {'measure': 'Number of Subjects With Any SAEs [Extension Period]', 'timeFrame': 'From the Day of 2nd vaccination to Day 31 post 2nd vaccination', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.'}, {'measure': 'RSV A Neutralizing Antibody Geometric Mean Titers (GMTs) at Screening [Primary Study]', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60 (Estimated Dilution 60).\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.'}, {'measure': 'RSV A Neutralizing Antibody GMTs at Day 8 [Primary Study]', 'timeFrame': 'At Day 8', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.'}, {'measure': 'RSV A Neutralizing Antibody GMTs at Day 31 [Primary Study]', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.'}, {'measure': 'RSV PreF3 IgG Antibody Geometric Mean Concentration (GMCs) at Screening [Primary Study]', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA ).\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.'}, {'measure': 'RSV PreF3 IgG GMCs at Day 8 [Primary Study]', 'timeFrame': 'At Day 8', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA).\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.'}, {'measure': 'RSV PreF3 IgG GMCs at Day 31 [Primary Study]', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA).\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'From Day 1 to Day 8', 'description': 'Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.'}, {'measure': 'Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'From Day 1 to Day 8', 'description': 'Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever(body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.'}, {'measure': 'Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'From Day 1 to Day 31', 'description': "An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3."}, {'measure': 'Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'From Day 1 to Day 31', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.'}, {'measure': 'Number of Subjects With Any SAEs From 1st Vaccination to Day 181 [Primary Study]', 'timeFrame': 'From Day 1 to Day 181', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.'}, {'measure': 'Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'From Day 1 to Day 181', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.'}, {'measure': 'Number of Subjects With Any SAEs From 2nd Vaccination to Day 181 Post 2nd Vaccination [Extension Period]', 'timeFrame': 'From the Day of 2nd vaccination to Day 181 post 2nd vaccination', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.'}, {'measure': 'RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.'}, {'measure': 'RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'At Day 8', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.'}, {'measure': 'RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.'}, {'measure': 'RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'At a single timepoint between 12 to 18 months post 1st vaccination', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.'}, {'measure': 'RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study]', 'timeFrame': 'At a single timepoint between 12 to 18 months post 1st vaccination', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.'}, {'measure': 'RSV A Neutralizing GMTs at Day 31 Post 2nd Vaccination [Extension Study]', 'timeFrame': 'At Day 31 post 2nd vaccination', 'description': 'Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.'}, {'measure': 'RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.'}, {'measure': 'RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'At Day 8', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the Boostrix (300 μg or 500 μg of aluminum). The objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of Boostrix formulation on the immunogenicity response to RSVPreF3.'}, {'measure': 'RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.'}, {'measure': 'RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'At a single timepoint between 12 to 18 months post 1st vaccination', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the Boostrix (300 μg or 500 μg of aluminum). The objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of Boostrix formulation on the immunogenicity response to RSVPreF3.'}, {'measure': 'RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study]', 'timeFrame': 'At a single timepoint between 12 to 18 months post 1st vaccination', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL.\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.'}, {'measure': 'RSV PreF3 IgG GMCs at Day 31 Post 2nd Vaccination [Extension Study]', 'timeFrame': 'At Day 31 post 2nd vaccination', 'description': 'Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA.\n\nThe analysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled), RSV120\\_Placebo\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.'}, {'measure': 'Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).'}, {'measure': 'Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).'}, {'measure': 'Diphtheria (Anti-D) GMC at Screening by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).'}, {'measure': 'Diphtheria (Anti-D) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).'}, {'measure': 'Tetanus (Anti-T) GMCs at Screening by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).'}, {'measure': 'Tetanus (Anti-T) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA.\n\nThe analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).'}, {'measure': 'Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study]', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA.\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.'}, {'measure': 'Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study]', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA.\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.'}, {'measure': 'Diphtheria (Anti-D) GMCs at Screening [Primary Study]', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA.\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.'}, {'measure': 'Diphtheria (Anti-D) GMCs at Day 31 [Primary Study]', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA.\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.'}, {'measure': 'Tetanus (Anti-T) GMCs at Screening [Primary Study]', 'timeFrame': 'At Screening (Day -7 to Day 1)', 'description': 'Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA.\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.'}, {'measure': 'Tetanus (Anti-T) GMCs at Day 31 [Primary Study]', 'timeFrame': 'At Day 31', 'description': 'Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA.\n\nAnalysis of this outcome measure was reported for the Pooled groups \\[RSV120\\_dTpa\\_RSV120(Pooled), RSV60\\_dTpa\\_RSV120(Pooled) and dTpa\\_Placebo\\_RSV120(Pooled)\\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Syncytial Virus Infections']}, 'referencesModule': {'references': [{'pmid': '38133639', 'type': 'BACKGROUND', 'citation': 'Hermida N, Ferguson M, Leroux-Roels I, Pagnussat S, Yaplee D, Hua N, van den Steen P, Anspach B, Dieussaert I, Kim JH. Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion Maternal Vaccine Coadministered With Diphtheria-Tetanus-Pertussis Vaccine: A Phase 2 Study. J Infect Dis. 2024 Aug 16;230(2):e353-e362. doi: 10.1093/infdis/jiad560.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the safety, ability of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) to generate an immune response and the degree to which the vaccine can cause side effects, when administered alone and in combination with Boostrix vaccine in healthy non-pregnant women 18-45 years of age. Two dose levels of RSVPreF3 and 2 Boostrix \\[Diphtheria, Tetanus and acellular Pertussis (dTpa) vaccine\\] formulations (US and ex-US) will be evaluated. A 2nd dose of RSVPreF3 will be administered in an extension of the study to assess the durability of the immune response after the first dose vaccination, and to assess the safety and immunogenicity following a second dose vaccination of the RSVPreF3 maternal vaccine."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPrimary study\n\n* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n* Written or witnessed/thumb printed informed consent obtained from the subject prior to performance of any study specific procedure.\n* Healthy female subjects; as established by medical history and clinical examination, aged 18 to 45 years at the time of the 1st vaccination;\n* Female subjects of childbearing potential may be enrolled in the study, if the subject:\n\n * has practiced adequate contraception for 30 days prior to primary vaccination, and\n * has a negative pregnancy test on the day of primary vaccination, and\n * has agreed to continue adequate contraception for 90 days after completion of the vaccination.\n* No local condition precluding injection in both left and right deltoid muscles.\n\nExtension study\n\n* Completed primary study and received 1st dose of a study vaccine.\n* Written or witnessed/thumb printed informed consent obtained from the subject prior to performance of any study specific procedure to the study extension.\n\nAll subjects must satisfy ALL the following criteria:\n\n* Subjects who can and will comply with the requirements of the protocol.\n* Female subjects remain healthy; as established by medical history and clinical examination, aged 18 to 45 years at the time of the 1st vaccination;\n* Female subjects of childbearing potential are eligible for the extension, if the subject:\n\n * has practiced adequate contraception for 30 days prior to 2nd vaccination\n * has a negative pregnancy test with results available on the day of 2nd vaccination\n * has agreed to continue adequate contraception for 90 days after completion of the 2nd vaccination.\n\nExclusion Criteria:\n\nPrimary study\n\nMedical conditions\n\n* History of any reaction/hypersensitivity likely to be exacerbated by any vaccines' component;\n* Any confirmed/suspected immunosuppressive/immunodeficient condition, based on medical history and physical examination;\n* Hypersensitivity to latex;\n* Major congenital defects;\n* Acute/chronic clinically significant pulmonary, cardiovascular, hepatic/renal functional abnormality;\n* Significant/uncontrolled psychiatric illness;\n* Recurrent history/uncontrolled neurological disorders/seizures;\n* Documented HIV-positive subject;\n* History of/current autoimmune disease;\n* Body mass index (BMI)\\>40 kg/m\\^2;\n* Any clinically significant hematological parameter and/or biochemical laboratory abnormality.\n* Any other clinical condition that might pose additional risk to the subject due to participation in the study.\n\nPrior/Concomitant therapy\n\n* Use of any investigational/non-registered product other than the study vaccines during the period starting 30 days before 1st vaccination, or planned use during the study;\n* Administration of long-acting immune-modifying drugs at any time during the study;\n* Administration of immunoglobulins and/or any blood products/plasma derivatives during the period starting 3 months before the 1st vaccination or planned administration during the study;\n* Chronic administration of immunosuppressants/other immune-modifying drugs during the period starting 3 months prior to 1st vaccine dose(s). For corticosteroids, this will mean prednisone ≥5 mg/day, or equivalent. Inhaled and topical steroids are allowed;\n* Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study 1st vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before/after study vaccination;\n* Administration of a vaccine containing diphtheria, tetanus/pertussis antigens/diphtheria and tetanus toxoids within the previous 5 years;\n* Previous experimental vaccination against RSV;\n\nPrior/Concurrent clinical study experience • Concurrently participating in another clinical study, at any time during the study, in which the subject has been/will be exposed to an investigational/a non-investigational vaccine/product;\n\nOther exclusions\n\n* Pregnant/lactating female;\n* Female planning to become pregnant/planning to discontinue contraceptive precautions;\n* History of alcoholism, drug abuse and/or use disorder within the past 2 years;\n* Any study personnel/their immediate dependents, family/household members.\n\nExtension study\n\nMedical conditions\n\n* History of any reaction/hypersensitivity likely to be exacerbated by any component of the vaccines;\n* Any confirmed/suspected immunosuppressive/immunodeficient condition, based on medical history and physical examination;\n* Hypersensitivity to latex;\n* Acute/chronic clinically significant pulmonary, cardiovascular, hepatic/renal functional abnormality;\n* Significant/uncontrolled psychiatric illness;\n* Recurrent history/uncontrolled neurological disorders/seizures;\n* Documented HIV-positive subject;\n* History of/current autoimmune disease;\n* BMI\\>40 kg/m\\^2;\n* Participants who experienced any SAE judged to be possibly or probably related to 1st dose of RSVPreF3, including hypersensitivity reactions.\n* Any other clinical condition that might pose additional risk to the subject due to participation in the study.\n\nPrior/Concomitant therapy\n\n* Use of any investigational/non-registered product other than the study vaccines during the period starting 30 days before the 2nd vaccination, or planned use during the 6-month study extension;\n* Administration of long-acting immune-modifying drugs at any time during the study;\n* Administration of immunoglobulins and/or any blood products/plasma derivatives during the period starting 3 months before the 1st dose of study vaccines/planned administration during the study;\n* Chronic administration of immunosuppressants or other immune-modifying drugs during the starting 3 months prior to the 1st vaccine dose(s). For corticosteroids, this will mean prednisone ≥5 mg/day, or equivalent. Inhaled and topical steroids are allowed;\n* Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study 2nd vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before/after study vaccination.\n\nPrior/Concurrent clinical study experience\n\n• Concurrently participating in another clinical study, at any time during the study, in which the subject has been/will be exposed to an investigational/a non-investigational vaccine/product;\n\nOther exclusions\n\n* Pregnant/lactating female at the time of Visit 4;\n* Female planning to become pregnant/planning to discontinue contraceptive precautions;\n* History of alcoholism, drug abuse and/or use disorder within the past 2 years;\n* Any study personnel/their immediate dependents, family/household members."}, 'identificationModule': {'nctId': 'NCT04138056', 'briefTitle': 'A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase II Study of a Primary Dose of Investigational RSV Maternal Vaccine, Given Alone or With Boostrix, With a 2nd Dose Investigational RSV Maternal Vaccine', 'orgStudyIdInfo': {'id': '209141'}, 'secondaryIdInfos': [{'id': '2019-002258-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RSV120_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.', 'interventionNames': ['Biological: RSVPreF3 formulation 3', 'Biological: Boostrix-ex-US', 'Biological: Boostrix-US']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'RSV120_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.', 'interventionNames': ['Biological: RSVPreF3 formulation 3', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'RSV60_dTpa_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.', 'interventionNames': ['Biological: RSVPreF3 formulation 3', 'Biological: RSVPreF3 formulation 2', 'Biological: Boostrix-ex-US', 'Biological: Boostrix-US']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'RSV60_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.', 'interventionNames': ['Biological: RSVPreF3 formulation 3', 'Biological: RSVPreF3 formulation 2', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'dTpa_Placebo_RSV120(Pooled)', 'description': 'Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.', 'interventionNames': ['Biological: RSVPreF3 formulation 3', 'Biological: Boostrix-ex-US', 'Biological: Boostrix-US', 'Drug: Placebo']}], 'interventions': [{'name': 'RSVPreF3 formulation 3', 'type': 'BIOLOGICAL', 'description': 'One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.', 'armGroupLabels': ['RSV120_Placebo_RSV120(Pooled)', 'RSV120_dTpa_RSV120(Pooled)', 'RSV60_Placebo_RSV120(Pooled)', 'RSV60_dTpa_RSV120(Pooled)', 'dTpa_Placebo_RSV120(Pooled)']}, {'name': 'RSVPreF3 formulation 2', 'type': 'BIOLOGICAL', 'description': 'One dose of RSVPreF3 formulation 2 vaccine administered intramuscularly in the left arm.', 'armGroupLabels': ['RSV60_Placebo_RSV120(Pooled)', 'RSV60_dTpa_RSV120(Pooled)']}, {'name': 'Boostrix-ex-US', 'type': 'BIOLOGICAL', 'description': 'One dose of the dTpa (Ex-US formulation) vaccine administered intramuscularly in the right arm.', 'armGroupLabels': ['RSV120_dTpa_RSV120(Pooled)', 'RSV60_dTpa_RSV120(Pooled)', 'dTpa_Placebo_RSV120(Pooled)']}, {'name': 'Boostrix-US', 'type': 'BIOLOGICAL', 'description': 'One dose of the dTpa vaccine (US formulation) administered intramuscularly in the right arm.', 'armGroupLabels': ['RSV120_dTpa_RSV120(Pooled)', 'RSV60_dTpa_RSV120(Pooled)', 'dTpa_Placebo_RSV120(Pooled)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One dose of placebo (NaCl solution) administered intramuscularly in either the left or the right arm.', 'armGroupLabels': ['RSV120_Placebo_RSV120(Pooled)', 'RSV60_Placebo_RSV120(Pooled)', 'dTpa_Placebo_RSV120(Pooled)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'B2N 1L2', 'city': 'Truro', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.36685, 'lon': -63.26538}}, {'zip': 'N5W 6A2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.', 'ipdSharing': 'YES', 'description': 'GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\\_GSK\\_Patient\\_Level\\_Data\\_Sharing\\_Final\\_13July2023.pdf', 'accessCriteria': 'Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}