Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-02-22 @ 4:13 PM
Study NCT ID:
NCT04032093
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2019-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022261', 'term': 'Respiratory Syncytial Virus Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants', 'description': 'Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Maternal Participants: RSVpreF 120 mcg', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.', 'otherNumAtRisk': 115, 'deathsNumAtRisk': 115, 'otherNumAffected': 87, 'seriousNumAtRisk': 115, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 108, 'seriousNumAtRisk': 117, 'deathsNumAffected': 0, 'seriousNumAffected': 15}, {'id': 'EG002', 'title': 'Maternal Participants: RSVpreF 240 mcg', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 96, 'seriousNumAtRisk': 116, 'deathsNumAffected': 0, 'seriousNumAffected': 15}, {'id': 'EG003', 'title': 'Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 103, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 19}, {'id': 'EG004', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 89, 'seriousNumAtRisk': 117, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG005', 'title': 'Infant Participants: RSVpreF 120 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 66, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 41}, {'id': 'EG006', 'title': 'Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 59, 'seriousNumAtRisk': 117, 'deathsNumAffected': 0, 'seriousNumAffected': 39}, {'id': 'EG007', 'title': 'Infant Participants: RSVpreF 240 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.', 'otherNumAtRisk': 113, 'deathsNumAtRisk': 113, 'otherNumAffected': 67, 'seriousNumAtRisk': 113, 'deathsNumAffected': 0, 'seriousNumAffected': 35}, {'id': 'EG008', 'title': 'Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.', 'otherNumAtRisk': 112, 'deathsNumAtRisk': 112, 'otherNumAffected': 66, 'seriousNumAtRisk': 112, 'deathsNumAffected': 0, 'seriousNumAffected': 44}, {'id': 'EG009', 'title': 'Infant Participants: Placebo', 'description': 'Infant participants who were born to maternal participants administered with placebo (normal sterile saline solution) during pregnancy were included. Infant participants were followed up to 12 months after birth.', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 71, 'seriousNumAtRisk': 116, 'deathsNumAffected': 0, 'seriousNumAffected': 38}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Nonreassuring foetal heart rate pattern', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Diarrhoea (DIARRHOEA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 7}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Nausea (NAUSEA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 26}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Vomiting (VOMITING)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Fatigue (FATIGUE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 53}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 58}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 55}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Injection site erythema (REDNESS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Injection site pain (PAIN AT INJECTION SITE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 81}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 69}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Injection site swelling (SWELLING)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pyrexia (FEVER)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Bacterial disease carrier', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 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{'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Cafe au lait spots', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Macule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Subgaleal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Meconium aspiration syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Neonatal aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Neonatal hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Neonatal pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Neonatal respiratory depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Neonatal respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Neonatal respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Neonatal respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Transient tachypnoea of the newborn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}, {'value': '117', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: RSVpreF 120 mcg', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG002', 'title': 'Maternal Participants: RSVpreF 240 mcg', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG003', 'title': 'Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG004', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.'}], 'classes': [{'title': 'Redness: Mild', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '8.7'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '7.4'}, {'value': '5.2', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '10.9'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '4.8'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Redness: Moderate', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.8'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '6.1'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '2.6', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '7.5'}, {'value': '0.9', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '4.7'}]}]}, {'title': 'Redness: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Swelling: Mild', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '8.7'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '7.4'}, {'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '9.8'}, {'value': '3.5', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '8.7'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Swelling: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '7.4'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '4.8'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Swelling: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Pain at injection site: Mild', 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000', 'lowerLimit': '15.5', 'upperLimit': '31.6'}, {'value': '53.0', 'groupId': 'OG001', 'lowerLimit': '43.5', 'upperLimit': '62.4'}, {'value': '28.4', 'groupId': 'OG002', 'lowerLimit': '20.5', 'upperLimit': '37.6'}, {'value': '47.4', 'groupId': 'OG003', 'lowerLimit': '37.9', 'upperLimit': '56.9'}, {'value': '12.8', 'groupId': 'OG004', 'lowerLimit': '7.4', 'upperLimit': '20.3'}]}]}, {'title': 'Pain at injection site: Moderate', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '12.2'}, {'value': '15.7', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '23.6'}, {'value': '5.2', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '10.9'}, {'value': '13.2', 'groupId': 'OG003', 'lowerLimit': '7.6', 'upperLimit': '20.8'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Pain at injection site: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '6.1'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after vaccination', 'description': 'Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\\>) 2.0 to 5.0 cm, moderate: \\>5.0 to 10.0 cm and severe: \\>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. The maximum severity was defined as highest grading of each local reaction within 7 days of vaccination.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maternal safety population included all randomized maternal participants who received investigational product and were analyzed according to the investigational product they received. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}, {'value': '117', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: RSVpreF 120 mcg', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG002', 'title': 'Maternal Participants: RSVpreF 240 mcg', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG003', 'title': 'Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG004', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.'}], 'classes': [{'title': 'Fever: Grade 1', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '7.5'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Fever: Grade 2', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.8'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '7.4'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '6.1'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '4.8'}, {'value': '0.9', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '4.7'}]}]}, {'title': 'Fever: Grade 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Fever: Grade 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Fatigue: Mild', 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000', 'lowerLimit': '15.5', 'upperLimit': '31.6'}, {'value': '27.0', 'groupId': 'OG001', 'lowerLimit': '19.1', 'upperLimit': '36.0'}, {'value': '23.3', 'groupId': 'OG002', 'lowerLimit': '15.9', 'upperLimit': '32.0'}, {'value': '25.4', 'groupId': 'OG003', 'lowerLimit': '17.7', 'upperLimit': '34.4'}, {'value': '24.8', 'groupId': 'OG004', 'lowerLimit': '17.3', 'upperLimit': '33.6'}]}]}, {'title': 'Fatigue: Moderate', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '33.5'}, {'value': '17.4', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '25.6'}, {'value': '19.8', 'groupId': 'OG002', 'lowerLimit': '13.0', 'upperLimit': '28.3'}, {'value': '23.7', 'groupId': 'OG003', 'lowerLimit': '16.2', 'upperLimit': '32.6'}, {'value': '20.5', 'groupId': 'OG004', 'lowerLimit': '13.6', 'upperLimit': '29.0'}]}]}, {'title': 'Fatigue: Severe', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.8'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '8.7'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '7.4'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '6.2'}, {'value': '1.7', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '6.0'}]}]}, {'title': 'Headache: Mild', 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '26.8'}, {'value': '19.1', 'groupId': 'OG001', 'lowerLimit': '12.4', 'upperLimit': '27.5'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '17.4', 'upperLimit': '33.9'}, {'value': '18.4', 'groupId': 'OG003', 'lowerLimit': '11.8', 'upperLimit': '26.8'}, {'value': '14.5', 'groupId': 'OG004', 'lowerLimit': '8.7', 'upperLimit': '22.2'}]}]}, {'title': 'Headache: Moderate', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '17.7'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '24.6'}, {'value': '12.1', 'groupId': 'OG002', 'lowerLimit': '6.8', 'upperLimit': '19.4'}, {'value': '10.5', 'groupId': 'OG003', 'lowerLimit': '5.6', 'upperLimit': '17.7'}, {'value': '9.4', 'groupId': 'OG004', 'lowerLimit': '4.8', 'upperLimit': '16.2'}]}]}, {'title': 'Headache: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '6.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '1.7', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '6.0'}]}]}, {'title': 'Nausea: Mild', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '22.8'}, {'value': '17.4', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '25.6'}, {'value': '16.4', 'groupId': 'OG002', 'lowerLimit': '10.2', 'upperLimit': '24.4'}, {'value': '14.9', 'groupId': 'OG003', 'lowerLimit': '8.9', 'upperLimit': '22.8'}, {'value': '16.2', 'groupId': 'OG004', 'lowerLimit': '10.1', 'upperLimit': '24.2'}]}]}, {'title': 'Nausea: Moderate', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '24.8'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '15.4'}, {'value': '8.6', 'groupId': 'OG002', 'lowerLimit': '4.2', 'upperLimit': '15.3'}, {'value': '4.4', 'groupId': 'OG003', 'lowerLimit': '1.4', 'upperLimit': '9.9'}, {'value': '6.0', 'groupId': 'OG004', 'lowerLimit': '2.4', 'upperLimit': '11.9'}]}]}, {'title': 'Nausea: Severe', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.8'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Muscle pain: Mild', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '22.8'}, {'value': '28.7', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': '37.9'}, {'value': '21.6', 'groupId': 'OG002', 'lowerLimit': '14.5', 'upperLimit': '30.1'}, {'value': '21.9', 'groupId': 'OG003', 'lowerLimit': '14.7', 'upperLimit': '30.6'}, {'value': '6.8', 'groupId': 'OG004', 'lowerLimit': '3.0', 'upperLimit': '13.0'}]}]}, {'title': 'Muscle pain: Moderate', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '18.7'}, {'value': '14.8', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '22.6'}, {'value': '12.1', 'groupId': 'OG002', 'lowerLimit': '6.8', 'upperLimit': '19.4'}, {'value': '14.0', 'groupId': 'OG003', 'lowerLimit': '8.2', 'upperLimit': '21.8'}, {'value': '5.1', 'groupId': 'OG004', 'lowerLimit': '1.9', 'upperLimit': '10.8'}]}]}, {'title': 'Muscle pain: Severe', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.8'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Joint pain: Mild', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '9.9'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '14.3'}, {'value': '11.2', 'groupId': 'OG002', 'lowerLimit': '6.1', 'upperLimit': '18.4'}, {'value': '7.0', 'groupId': 'OG003', 'lowerLimit': '3.1', 'upperLimit': '13.4'}, {'value': '5.1', 'groupId': 'OG004', 'lowerLimit': '1.9', 'upperLimit': '10.8'}]}]}, {'title': 'Joint pain: Moderate', 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '16.6'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '8.7'}, {'value': '9.5', 'groupId': 'OG002', 'lowerLimit': '4.8', 'upperLimit': '16.3'}, {'value': '3.5', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '8.7'}, {'value': '4.3', 'groupId': 'OG004', 'lowerLimit': '1.4', 'upperLimit': '9.7'}]}]}, {'title': 'Joint pain: Severe', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.8'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Vomiting: Mild', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '18.7'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '14.3'}, {'value': '5.2', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '10.9'}, {'value': '4.4', 'groupId': 'OG003', 'lowerLimit': '1.4', 'upperLimit': '9.9'}, {'value': '6.0', 'groupId': 'OG004', 'lowerLimit': '2.4', 'upperLimit': '11.9'}]}]}, {'title': 'Vomiting: Moderate', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '11.1'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '11.0'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '6.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '1.7', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '6.0'}]}]}, {'title': 'Vomiting: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Diarrhea: Mild', 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '16.6'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '17.5'}, {'value': '9.5', 'groupId': 'OG002', 'lowerLimit': '4.8', 'upperLimit': '16.3'}, {'value': '7.0', 'groupId': 'OG003', 'lowerLimit': '3.1', 'upperLimit': '13.4'}, {'value': '12.0', 'groupId': 'OG004', 'lowerLimit': '6.7', 'upperLimit': '19.3'}]}]}, {'title': 'Diarrhea: Moderate', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '8.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '6.1'}, {'value': '3.5', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '8.7'}, {'value': '1.7', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '6.0'}]}]}, {'title': 'Diarrhea: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '4.8'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after vaccination', 'description': 'Systemic events included fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and were recorded by participants in an e-diary. Fever was categorized as: grade 1: mild (\\>=38.0 to 38.4 degrees \\[deg\\] Celsius \\[C\\]), grade 2: moderate (\\>38.4 to 38.9 deg C), grade 3: severe (\\>38.9 to 40.0 deg C) and grade 4 (\\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \\>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. The maximum severity was defined as highest grading of each systemic event within 7 days of vaccination.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maternal safety population included all randomized maternal participants who received investigational product and were analyzed according to the investigational product they received. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Maternal Participants With Adverse Events (AEs) Within 1 Month After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}, {'value': '117', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: RSVpreF 120 mcg', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG002', 'title': 'Maternal Participants: RSVpreF 240 mcg', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG003', 'title': 'Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG004', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '31.3'}, {'value': '23.9', 'groupId': 'OG001', 'lowerLimit': '16.5', 'upperLimit': '32.7'}, {'value': '30.2', 'groupId': 'OG002', 'lowerLimit': '22.0', 'upperLimit': '39.4'}, {'value': '22.8', 'groupId': 'OG003', 'lowerLimit': '15.5', 'upperLimit': '31.6'}, {'value': '24.8', 'groupId': 'OG004', 'lowerLimit': '17.3', 'upperLimit': '33.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 month after vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maternal safety population included all randomized maternal participants who received investigational product and were analyzed according to the investigational product they received.'}, {'type': 'PRIMARY', 'title': 'Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}, {'value': '117', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: RSVpreF 120 mcg', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG002', 'title': 'Maternal Participants: RSVpreF 240 mcg', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG003', 'title': 'Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG004', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '12.1'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '20.3'}, {'value': '12.9', 'groupId': 'OG002', 'lowerLimit': '7.4', 'upperLimit': '20.4'}, {'value': '16.7', 'groupId': 'OG003', 'lowerLimit': '10.3', 'upperLimit': '24.8'}, {'value': '12.0', 'groupId': 'OG004', 'lowerLimit': '6.7', 'upperLimit': '19.3'}]}]}, {'title': 'MAE', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '28.5'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '12.2', 'upperLimit': '27.1'}, {'value': '15.5', 'groupId': 'OG002', 'lowerLimit': '9.5', 'upperLimit': '23.4'}, {'value': '21.1', 'groupId': 'OG003', 'lowerLimit': '14.0', 'upperLimit': '29.7'}, {'value': '17.1', 'groupId': 'OG004', 'lowerLimit': '10.8', 'upperLimit': '25.2'}]}]}, {'title': 'Obstetric complications', 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '32.3'}, {'value': '28.2', 'groupId': 'OG001', 'lowerLimit': '20.3', 'upperLimit': '37.3'}, {'value': '30.2', 'groupId': 'OG002', 'lowerLimit': '22.0', 'upperLimit': '39.4'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '24.8', 'upperLimit': '42.8'}, {'value': '32.5', 'groupId': 'OG004', 'lowerLimit': '24.1', 'upperLimit': '41.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From day of vaccination (Day 1) up to 12 months post-delivery', 'description': "MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Obstetric complications were determined as per the study clinician's judgement.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maternal safety population included all randomized maternal participants who received investigational product and were analyzed according to the investigational product they received.'}, {'type': 'PRIMARY', 'title': 'Percentage of Infant Participants With Specific Birth Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Infant Participants: RSVpreF 120 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG001', 'title': 'Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG002', 'title': 'Infant Participants: RSVpreF 240 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG003', 'title': 'Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG004', 'title': 'Infant Participants: Placebo', 'description': 'Infant participants who were born to maternal participants administered with placebo (normal sterile saline solution) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '14.5'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '17.2'}, {'value': '8.8', 'groupId': 'OG002', 'lowerLimit': '4.3', 'upperLimit': '15.7'}, {'value': '8.0', 'groupId': 'OG003', 'lowerLimit': '3.7', 'upperLimit': '14.7'}, {'value': '9.5', 'groupId': 'OG004', 'lowerLimit': '4.8', 'upperLimit': '16.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At birth', 'description': 'Specific birth complications included clavicle fracture, torticollis, cephalhematoma, premature baby, acute respiratory failure, meconium aspiration syndrome, neonatal pneumothorax, neonatal respiratory depression, neonatal respiratory distress, neonatal respiratory distress syndrome, neonatal respiratory failure, pneumothorax, respiratory distress, transient tachypnea of the newborn and subgaleal hemorrhage. Percentage of participants with any specific birth complications were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Infant safety population included all infant participants who were born to vaccinated maternal participants and were analyzed according to the investigational product their mothers received.'}, {'type': 'PRIMARY', 'title': 'Percentage of Infant Participants With Any AE Within 1 Month of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Infant Participants: RSVpreF 120 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG001', 'title': 'Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG002', 'title': 'Infant Participants: RSVpreF 240 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG003', 'title': 'Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG004', 'title': 'Infant Participants: Placebo', 'description': 'Infant participants who were born to maternal participants administered with placebo (normal sterile saline solution) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.9', 'groupId': 'OG000', 'lowerLimit': '41.3', 'upperLimit': '60.4'}, {'value': '47.0', 'groupId': 'OG001', 'lowerLimit': '37.7', 'upperLimit': '56.5'}, {'value': '46.9', 'groupId': 'OG002', 'lowerLimit': '37.5', 'upperLimit': '56.5'}, {'value': '49.1', 'groupId': 'OG003', 'lowerLimit': '39.5', 'upperLimit': '58.7'}, {'value': '50.9', 'groupId': 'OG004', 'lowerLimit': '41.4', 'upperLimit': '60.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 month after birth', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Infant safety population included all infant participants who were born to vaccinated maternal participants and were analyzed according to the investigational product their mothers received.'}, {'type': 'PRIMARY', 'title': 'Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Infant Participants: RSVpreF 120 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG001', 'title': 'Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG002', 'title': 'Infant Participants: RSVpreF 240 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG003', 'title': 'Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG004', 'title': 'Infant Participants: Placebo', 'description': 'Infant participants who were born to maternal participants administered with placebo (normal sterile saline solution) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}], 'classes': [{'title': 'MAE', 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000', 'lowerLimit': '15.5', 'upperLimit': '31.6'}, {'value': '29.9', 'groupId': 'OG001', 'lowerLimit': '21.8', 'upperLimit': '39.1'}, {'value': '30.1', 'groupId': 'OG002', 'lowerLimit': '21.8', 'upperLimit': '39.4'}, {'value': '38.4', 'groupId': 'OG003', 'lowerLimit': '29.4', 'upperLimit': '48.1'}, {'value': '31.9', 'groupId': 'OG004', 'lowerLimit': '23.6', 'upperLimit': '41.2'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000', 'lowerLimit': '27.2', 'upperLimit': '45.5'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '24.9', 'upperLimit': '42.6'}, {'value': '31.0', 'groupId': 'OG002', 'lowerLimit': '22.6', 'upperLimit': '40.4'}, {'value': '39.3', 'groupId': 'OG003', 'lowerLimit': '30.2', 'upperLimit': '49.0'}, {'value': '32.8', 'groupId': 'OG004', 'lowerLimit': '24.3', 'upperLimit': '42.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 12 months after birth', 'description': 'MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Infant safety population included all infant participants who were born to vaccinated maternal participants and were analyzed according to the investigational product their mothers received.'}, {'type': 'PRIMARY', 'title': 'Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Infant Participants: RSVpreF 120 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG001', 'title': 'Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG002', 'title': 'Infant Participants: RSVpreF 240 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG003', 'title': 'Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG004', 'title': 'Infant Participants: Placebo', 'description': 'Infant participants who were born to maternal participants administered with placebo (normal sterile saline solution) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}], 'classes': [{'title': 'Congenital Anomalies', 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '16.6'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '9.7'}, {'value': '1.8', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '6.2'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '6.3'}, {'value': '6.0', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '12.0'}]}]}, {'title': 'Developmental Delay', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 12 months after birth', 'description': "AEs of special interest for infant participants included congenital anomalies and developmental delays. Congenital anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life. Severity was assessed based on the study investigator's judgement and graded as grade 1= mild (does not interfere with participant's usual function); grade 2= moderate (interferes to some extent with participant's usual function); grade 3= severe (interferes significantly with participant's usual function) and grade 4= life-threatening (life-threatening consequences; urgent intervention indicated). Percentage of infant participants with AEs of special interest of at least moderate severity were presented.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Infant safety population included all infant participants who were born to vaccinated maternal participants and were analyzed according to the investigational product their mothers received.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}, {'value': '115', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: RSVpreF 120 mcg', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG002', 'title': 'Maternal Participants: RSVpreF 240 mcg', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG003', 'title': 'Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG004', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.'}], 'classes': [{'title': 'A 50%: Before vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1574', 'groupId': 'OG000', 'lowerLimit': '1369.2', 'upperLimit': '1808.7'}, {'value': '1577', 'groupId': 'OG001', 'lowerLimit': '1343.2', 'upperLimit': '1850.9'}, {'value': '1432', 'groupId': 'OG002', 'lowerLimit': '1221.3', 'upperLimit': '1678.2'}, {'value': '1521', 'groupId': 'OG003', 'lowerLimit': '1318.6', 'upperLimit': '1754.4'}, {'value': '1450', 'groupId': 'OG004', 'lowerLimit': '1263.5', 'upperLimit': '1663.3'}]}]}, {'title': 'A 50%: 2 Weeks after vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}, {'value': '104', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '31871', 'groupId': 'OG000', 'lowerLimit': '27687.5', 'upperLimit': '36685.8'}, {'value': '31644', 'groupId': 'OG001', 'lowerLimit': '25759.8', 'upperLimit': '38873.3'}, {'value': '33532', 'groupId': 'OG002', 'lowerLimit': '28298.3', 'upperLimit': '39733.8'}, {'value': '39874', 'groupId': 'OG003', 'lowerLimit': '33992.0', 'upperLimit': '46773.6'}, {'value': '1597', 'groupId': 'OG004', 'lowerLimit': '1357.6', 'upperLimit': '1879.4'}]}]}, {'title': 'A 50%: 1 Month after vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '24149', 'groupId': 'OG000', 'lowerLimit': '19744.0', 'upperLimit': '29537.1'}, {'value': '31007', 'groupId': 'OG001', 'lowerLimit': '26875.8', 'upperLimit': '35773.7'}, {'value': '23692', 'groupId': 'OG002', 'lowerLimit': '19234.9', 'upperLimit': '29182.2'}, {'value': '28106', 'groupId': 'OG003', 'lowerLimit': '24409.9', 'upperLimit': '32362.2'}, {'value': '1549', 'groupId': 'OG004', 'lowerLimit': '1294.9', 'upperLimit': '1853.7'}]}]}, {'title': 'A 50%: At delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}, {'value': '111', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12914', 'groupId': 'OG000', 'lowerLimit': '10781.2', 'upperLimit': '15469.2'}, {'value': '17259', 'groupId': 'OG001', 'lowerLimit': '14982.9', 'upperLimit': '19881.3'}, {'value': '12231', 'groupId': 'OG002', 'lowerLimit': '9925.5', 'upperLimit': '15071.8'}, {'value': '15814', 'groupId': 'OG003', 'lowerLimit': '13512.2', 'upperLimit': '18507.5'}, {'value': '1150', 'groupId': 'OG004', 'lowerLimit': '957.4', 'upperLimit': '1380.3'}]}]}, {'title': 'B 50%: Before vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}, {'value': '115', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1756', 'groupId': 'OG000', 'lowerLimit': '1513.0', 'upperLimit': '2038.3'}, {'value': '1756', 'groupId': 'OG001', 'lowerLimit': '1475.2', 'upperLimit': '2090.8'}, {'value': '1647', 'groupId': 'OG002', 'lowerLimit': '1387.5', 'upperLimit': '1955.6'}, {'value': '1792', 'groupId': 'OG003', 'lowerLimit': '1510.8', 'upperLimit': '2125.2'}, {'value': '1652', 'groupId': 'OG004', 'lowerLimit': '1419.8', 'upperLimit': '1923.2'}]}]}, {'title': 'B 50%: 2 Weeks after vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}, {'value': '104', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '39152', 'groupId': 'OG000', 'lowerLimit': '31938.0', 'upperLimit': '47996.6'}, {'value': '36382', 'groupId': 'OG001', 'lowerLimit': '28841.0', 'upperLimit': '45893.9'}, {'value': '43030', 'groupId': 'OG002', 'lowerLimit': '35419.6', 'upperLimit': '52275.2'}, {'value': '55967', 'groupId': 'OG003', 'lowerLimit': '46848.7', 'upperLimit': '66861.1'}, {'value': '1615', 'groupId': 'OG004', 'lowerLimit': '1354.4', 'upperLimit': '1926.1'}]}]}, {'title': 'B 50%: 1 Month after vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '34397', 'groupId': 'OG000', 'lowerLimit': '28139.5', 'upperLimit': '42046.9'}, {'value': '37931', 'groupId': 'OG001', 'lowerLimit': '31958.7', 'upperLimit': '45019.8'}, {'value': '30339', 'groupId': 'OG002', 'lowerLimit': '23978.7', 'upperLimit': '38387.3'}, {'value': '39055', 'groupId': 'OG003', 'lowerLimit': '32898.8', 'upperLimit': '46363.2'}, {'value': '1686', 'groupId': 'OG004', 'lowerLimit': '1415.4', 'upperLimit': '2007.3'}]}]}, {'title': 'B 50%: At delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}, {'value': '111', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16157', 'groupId': 'OG000', 'lowerLimit': '12864.8', 'upperLimit': '20291.4'}, {'value': '19952', 'groupId': 'OG001', 'lowerLimit': '16221.3', 'upperLimit': '24540.1'}, {'value': '16011', 'groupId': 'OG002', 'lowerLimit': '12916.4', 'upperLimit': '19847.7'}, {'value': '19130', 'groupId': 'OG003', 'lowerLimit': '15276.7', 'upperLimit': '23955.2'}, {'value': '1184', 'groupId': 'OG004', 'lowerLimit': '977.1', 'upperLimit': '1435.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.3', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: Before vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.0', 'ciLowerLimit': '16.1', 'ciUpperLimit': '24.7', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 2 Weeks after vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.6', 'ciLowerLimit': '11.9', 'ciUpperLimit': '20.4', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 1 Month after vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.2', 'ciLowerLimit': '8.7', 'ciUpperLimit': '14.5', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: At delivery', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.3', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: Before vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.2', 'ciLowerLimit': '18.5', 'ciUpperLimit': '31.7', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 2 Weeks after vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.4', 'ciLowerLimit': '15.7', 'ciUpperLimit': '26.6', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 1 Month after vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.6', 'ciLowerLimit': '10.1', 'ciUpperLimit': '18.4', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: At delivery', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.3', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: Before vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.8', 'ciLowerLimit': '15.3', 'ciUpperLimit': '25.7', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 2 Weeks after vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.0', 'ciLowerLimit': '15.9', 'ciUpperLimit': '25.1', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 1 Month after vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.0', 'ciLowerLimit': '11.9', 'ciUpperLimit': '18.9', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: At delivery', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.3', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: Before vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.5', 'ciLowerLimit': '16.9', 'ciUpperLimit': '30.1', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 2 Weeks after vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.5', 'ciLowerLimit': '17.6', 'ciUpperLimit': '28.7', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 1 Month after vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.8', 'ciLowerLimit': '12.7', 'ciUpperLimit': '22.3', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: At delivery', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.2', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: Before vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.0', 'ciLowerLimit': '16.6', 'ciUpperLimit': '26.5', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 2 Weeks after vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.3', 'ciLowerLimit': '11.6', 'ciUpperLimit': '20.1', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 1 Month after vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.6', 'ciLowerLimit': '8.1', 'ciUpperLimit': '14.0', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: At delivery', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.3', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: Before vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.6', 'ciLowerLimit': '20.5', 'ciUpperLimit': '34.6', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 2 Weeks after vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.0', 'ciLowerLimit': '13.5', 'ciUpperLimit': '24.1', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 1 Month after vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.5', 'ciLowerLimit': '10.1', 'ciUpperLimit': '18.0', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: At delivery', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.3', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: Before vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.0', 'ciLowerLimit': '19.9', 'ciUpperLimit': '31.3', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 2 Weeks after vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.1', 'ciLowerLimit': '14.5', 'ciUpperLimit': '22.8', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 1 Month after vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.8', 'ciLowerLimit': '10.8', 'ciUpperLimit': '17.5', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: At delivery', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.4', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: Before vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.7', 'ciLowerLimit': '27.0', 'ciUpperLimit': '44.4', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 2 Weeks after vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.2', 'ciLowerLimit': '18.2', 'ciUpperLimit': '29.6', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 1 Month after vaccination', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.2', 'ciLowerLimit': '12.0', 'ciUpperLimit': '21.7', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: At delivery', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before vaccination, 2 weeks and 1 month after vaccination and at delivery', 'description': 'GMT of the 50% RSV A and RSV B neutralizing antibody were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student t distribution. Geometric mean ratios (GMRs) of the RSV vaccine group to the placebo group for the RSV A and RSV B neutralizing antibody titers at each time point was calculated and reported in statistical analysis.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maternal evaluable immunogenicity population: eligible maternal participants who received randomized vaccine, had blood collection within protocol-specified time points, had at least 1 valid and determinate assay result after vaccination and had no other major protocol deviations. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}, {'value': '111', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: RSVpreF 120 mcg', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG002', 'title': 'Maternal Participants: RSVpreF 240 mcg', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG003', 'title': 'Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'OG004', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.'}], 'classes': [{'title': 'A 50%: 2 Weeks after vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}, {'value': '103', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000', 'lowerLimit': '16.35', 'upperLimit': '24.04'}, {'value': '20.4', 'groupId': 'OG001', 'lowerLimit': '16.12', 'upperLimit': '25.77'}, {'value': '23.3', 'groupId': 'OG002', 'lowerLimit': '19.27', 'upperLimit': '28.10'}, {'value': '25.3', 'groupId': 'OG003', 'lowerLimit': '20.97', 'upperLimit': '30.52'}, {'value': '1.1', 'groupId': 'OG004', 'lowerLimit': '0.95', 'upperLimit': '1.28'}]}]}, {'title': 'A 50%: 1 Month after vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}, {'value': '96', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '11.89', 'upperLimit': '18.65'}, {'value': '19.6', 'groupId': 'OG001', 'lowerLimit': '16.21', 'upperLimit': '23.61'}, {'value': '15.9', 'groupId': 'OG002', 'lowerLimit': '12.85', 'upperLimit': '19.80'}, {'value': '17.8', 'groupId': 'OG003', 'lowerLimit': '14.99', 'upperLimit': '21.04'}, {'value': '1.0', 'groupId': 'OG004', 'lowerLimit': '0.94', 'upperLimit': '1.18'}]}]}, {'title': 'A 50%: At delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '6.85', 'upperLimit': '10.05'}, {'value': '10.9', 'groupId': 'OG001', 'lowerLimit': '9.33', 'upperLimit': '12.78'}, {'value': '8.6', 'groupId': 'OG002', 'lowerLimit': '6.81', 'upperLimit': '10.74'}, {'value': '10.6', 'groupId': 'OG003', 'lowerLimit': '8.91', 'upperLimit': '12.56'}, {'value': '0.8', 'groupId': 'OG004', 'lowerLimit': '0.67', 'upperLimit': '0.95'}]}]}, {'title': 'B 50%: 2 Weeks after vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}, {'value': '104', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000', 'lowerLimit': '17.24', 'upperLimit': '27.47'}, {'value': '21.0', 'groupId': 'OG001', 'lowerLimit': '16.69', 'upperLimit': '26.35'}, {'value': '26.4', 'groupId': 'OG002', 'lowerLimit': '21.36', 'upperLimit': '32.51'}, {'value': '30.4', 'groupId': 'OG003', 'lowerLimit': '24.35', 'upperLimit': '37.83'}, {'value': '1.0', 'groupId': 'OG004', 'lowerLimit': '0.84', 'upperLimit': '1.16'}]}]}, {'title': 'B 50%: 1 Month after vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '15.43', 'upperLimit': '23.84'}, {'value': '22.0', 'groupId': 'OG001', 'lowerLimit': '18.30', 'upperLimit': '26.41'}, {'value': '17.7', 'groupId': 'OG002', 'lowerLimit': '13.94', 'upperLimit': '22.51'}, {'value': '20.9', 'groupId': 'OG003', 'lowerLimit': '17.42', 'upperLimit': '25.12'}, {'value': '1.0', 'groupId': 'OG004', 'lowerLimit': '0.90', 'upperLimit': '1.17'}]}]}, {'title': 'B 50%: At delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}, {'value': '111', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '7.19', 'upperLimit': '11.74'}, {'value': '11.2', 'groupId': 'OG001', 'lowerLimit': '9.20', 'upperLimit': '13.74'}, {'value': '9.5', 'groupId': 'OG002', 'lowerLimit': '7.80', 'upperLimit': '11.48'}, {'value': '10.7', 'groupId': 'OG003', 'lowerLimit': '8.49', 'upperLimit': '13.49'}, {'value': '0.7', 'groupId': 'OG004', 'lowerLimit': '0.61', 'upperLimit': '0.87'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2 weeks and 1 month after vaccination, at delivery', 'description': 'GMFRs for RSV A and RSV B neutralizing antibody titers from before vaccination to each available time point after vaccination were calculated by exponentiating the mean logarithm of the fold rises. Corresponding 95% CI was based on the Student t distribution. Data for this outcome measure was planned to be analyzed for maternal participants only.', 'unitOfMeasure': 'Fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maternal evaluable immunogenicity population: eligible maternal participants who received randomized vaccine, had blood collection within protocol-specified time points, had at least 1 valid and determinate assay result after vaccination and had no other major protocol deviations. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '106', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Infant Participants: RSVpreF 120 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG001', 'title': 'Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG002', 'title': 'Infant Participants: RSVpreF 240 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG003', 'title': 'Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'OG004', 'title': 'Infant Participants: Placebo', 'description': 'Infant participants who were born to maternal participants administered with placebo (normal sterile saline solution) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}], 'classes': [{'title': 'A 50%: At birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}, {'value': '106', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '22904', 'groupId': 'OG000', 'lowerLimit': '18636.8', 'upperLimit': '28147.5'}, {'value': '23281', 'groupId': 'OG001', 'lowerLimit': '19155.8', 'upperLimit': '28294.3'}, {'value': '20530', 'groupId': 'OG002', 'lowerLimit': '17271.7', 'upperLimit': '24403.0'}, {'value': '24290', 'groupId': 'OG003', 'lowerLimit': '19858.5', 'upperLimit': '29710.2'}, {'value': '2150', 'groupId': 'OG004', 'lowerLimit': '1776.7', 'upperLimit': '2602.6'}]}]}, {'title': 'A 50%: 1 Month after birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13532', 'groupId': 'OG000', 'lowerLimit': '8775.4', 'upperLimit': '20865.4'}, {'value': '14667', 'groupId': 'OG001', 'lowerLimit': '10428.4', 'upperLimit': '20627.6'}, {'value': '12685', 'groupId': 'OG002', 'lowerLimit': '9161.6', 'upperLimit': '17563.9'}, {'value': '15383', 'groupId': 'OG003', 'lowerLimit': '12253.4', 'upperLimit': '19311.4'}, {'value': '1514', 'groupId': 'OG004', 'lowerLimit': '1200.9', 'upperLimit': '1908.0'}]}]}, {'title': 'A 50%: 2 Months after birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11127', 'groupId': 'OG000', 'lowerLimit': '8424.3', 'upperLimit': '14695.8'}, {'value': '7455', 'groupId': 'OG001', 'lowerLimit': '5517.1', 'upperLimit': '10073.8'}, {'value': '6943', 'groupId': 'OG002', 'lowerLimit': '4890.5', 'upperLimit': '9858.0'}, {'value': '10552', 'groupId': 'OG003', 'lowerLimit': '8019.3', 'upperLimit': '13884.7'}, {'value': '702', 'groupId': 'OG004', 'lowerLimit': '529.5', 'upperLimit': '930.8'}]}]}, {'title': 'A 50%: 4 Months after birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2673', 'groupId': 'OG000', 'lowerLimit': '1904.5', 'upperLimit': '3753.0'}, {'value': '3919', 'groupId': 'OG001', 'lowerLimit': '2905.9', 'upperLimit': '5285.8'}, {'value': '2148', 'groupId': 'OG002', 'lowerLimit': '1681.5', 'upperLimit': '2743.3'}, {'value': '2936', 'groupId': 'OG003', 'lowerLimit': '2217.6', 'upperLimit': '3887.3'}, {'value': '478', 'groupId': 'OG004', 'lowerLimit': '336.3', 'upperLimit': '680.2'}]}]}, {'title': 'A 50%: 6 Months after birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1529', 'groupId': 'OG000', 'lowerLimit': '1164.8', 'upperLimit': '2008.3'}, {'value': '1124', 'groupId': 'OG001', 'lowerLimit': '790.0', 'upperLimit': '1600.4'}, {'value': '930', 'groupId': 'OG002', 'lowerLimit': '643.0', 'upperLimit': '1344.2'}, {'value': '1048', 'groupId': 'OG003', 'lowerLimit': '747.6', 'upperLimit': '1468.5'}, {'value': '233', 'groupId': 'OG004', 'lowerLimit': '176.2', 'upperLimit': '307.0'}]}]}, {'title': 'B 50%: At birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '106', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '30195', 'groupId': 'OG000', 'lowerLimit': '24308.9', 'upperLimit': '37506.3'}, {'value': '28437', 'groupId': 'OG001', 'lowerLimit': '22968.2', 'upperLimit': '35207.9'}, {'value': '25112', 'groupId': 'OG002', 'lowerLimit': '20172.4', 'upperLimit': '31262.1'}, {'value': '32967', 'groupId': 'OG003', 'lowerLimit': '27494.5', 'upperLimit': '39529.5'}, {'value': '2029', 'groupId': 'OG004', 'lowerLimit': '1669.5', 'upperLimit': '2466.2'}]}]}, {'title': 'B 50%: 1 Month after birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '17418', 'groupId': 'OG000', 'lowerLimit': '11133.3', 'upperLimit': '27251.5'}, {'value': '18708', 'groupId': 'OG001', 'lowerLimit': '12994.4', 'upperLimit': '26934.9'}, {'value': '17911', 'groupId': 'OG002', 'lowerLimit': '12397.2', 'upperLimit': '25876.7'}, {'value': '20353', 'groupId': 'OG003', 'lowerLimit': '15477.7', 'upperLimit': '26762.8'}, {'value': '1586', 'groupId': 'OG004', 'lowerLimit': '1181.0', 'upperLimit': '2129.1'}]}]}, {'title': 'B 50%: 2 Months after birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13411', 'groupId': 'OG000', 'lowerLimit': '10016.5', 'upperLimit': '17955.2'}, {'value': '8341', 'groupId': 'OG001', 'lowerLimit': '5847.7', 'upperLimit': '11898.6'}, {'value': '7251', 'groupId': 'OG002', 'lowerLimit': '5387.9', 'upperLimit': '9757.8'}, {'value': '12359', 'groupId': 'OG003', 'lowerLimit': '9060.4', 'upperLimit': '16857.4'}, {'value': '700', 'groupId': 'OG004', 'lowerLimit': '542.3', 'upperLimit': '903.6'}]}]}, {'title': 'B 50%: 4 Months after birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3168', 'groupId': 'OG000', 'lowerLimit': '2261.8', 'upperLimit': '4436.5'}, {'value': '4075', 'groupId': 'OG001', 'lowerLimit': '2952.0', 'upperLimit': '5624.6'}, {'value': '2621', 'groupId': 'OG002', 'lowerLimit': '2029.1', 'upperLimit': '3385.5'}, {'value': '4135', 'groupId': 'OG003', 'lowerLimit': '3093.4', 'upperLimit': '5526.2'}, {'value': '458', 'groupId': 'OG004', 'lowerLimit': '313.6', 'upperLimit': '668.3'}]}]}, {'title': 'B 50%: 6 Months after birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1609', 'groupId': 'OG000', 'lowerLimit': '1094.5', 'upperLimit': '2364.3'}, {'value': '1195', 'groupId': 'OG001', 'lowerLimit': '805.8', 'upperLimit': '1772.0'}, {'value': '956', 'groupId': 'OG002', 'lowerLimit': '656.8', 'upperLimit': '1392.7'}, {'value': '1381', 'groupId': 'OG003', 'lowerLimit': '966.6', 'upperLimit': '1972.0'}, {'value': '221', 'groupId': 'OG004', 'lowerLimit': '162.9', 'upperLimit': '300.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.7', 'ciLowerLimit': '8.1', 'ciUpperLimit': '14.1', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: At birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.9', 'ciLowerLimit': '5.5', 'ciUpperLimit': '14.5', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 1 Month after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.8', 'ciLowerLimit': '10.7', 'ciUpperLimit': '23.4', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 2 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.6', 'ciLowerLimit': '3.5', 'ciUpperLimit': '9.0', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 4 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.6', 'ciLowerLimit': '4.5', 'ciUpperLimit': '9.6', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 6 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.9', 'ciLowerLimit': '11.1', 'ciUpperLimit': '19.9', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: At birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.0', 'ciLowerLimit': '6.5', 'ciUpperLimit': '18.6', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 1 Month after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.2', 'ciLowerLimit': '13.1', 'ciUpperLimit': '28.0', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 2 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.9', 'ciLowerLimit': '4.2', 'ciUpperLimit': '11.4', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 4 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.3', 'ciLowerLimit': '4.5', 'ciUpperLimit': '11.8', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 6 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.8', 'ciLowerLimit': '8.3', 'ciUpperLimit': '14.2', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: At birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.7', 'ciLowerLimit': '6.5', 'ciUpperLimit': '14.5', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 1 Month after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.6', 'ciLowerLimit': '7.1', 'ciUpperLimit': '15.9', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 2 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.2', 'ciLowerLimit': '5.2', 'ciUpperLimit': '12.9', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 4 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.8', 'ciLowerLimit': '3.1', 'ciUpperLimit': '7.5', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 6 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.0', 'ciLowerLimit': '10.5', 'ciUpperLimit': '18.7', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: At birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.8', 'ciLowerLimit': '7.4', 'ciUpperLimit': '18.7', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 1 Month after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.9', 'ciLowerLimit': '7.7', 'ciUpperLimit': '18.3', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 2 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.9', 'ciLowerLimit': '5.5', 'ciUpperLimit': '14.5', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 4 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.4', 'ciLowerLimit': '3.3', 'ciUpperLimit': '8.8', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 6 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.5', 'ciLowerLimit': '7.4', 'ciUpperLimit': '12.3', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: At birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.4', 'ciLowerLimit': '5.7', 'ciUpperLimit': '12.4', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 1 Month after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.9', 'ciLowerLimit': '6.4', 'ciUpperLimit': '15.4', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 2 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.5', 'ciLowerLimit': '2.9', 'ciUpperLimit': '6.8', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 4 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.0', 'ciLowerLimit': '2.5', 'ciUpperLimit': '6.3', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 6 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.4', 'ciLowerLimit': '9.2', 'ciUpperLimit': '16.6', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: At birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.3', 'ciLowerLimit': '7.1', 'ciUpperLimit': '17.9', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 1 Month after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.4', 'ciLowerLimit': '7.0', 'ciUpperLimit': '15.2', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 2 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.7', 'ciLowerLimit': '3.7', 'ciUpperLimit': '9.0', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 4 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '2.7', 'ciUpperLimit': '7.0', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 6 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.3', 'ciLowerLimit': '8.6', 'ciUpperLimit': '14.9', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: At birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.2', 'ciLowerLimit': '7.4', 'ciUpperLimit': '14.0', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 1 Month after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.0', 'ciLowerLimit': '10.2', 'ciUpperLimit': '22.1', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 2 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.1', 'ciLowerLimit': '3.9', 'ciUpperLimit': '9.6', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 4 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.5', 'ciLowerLimit': '2.9', 'ciUpperLimit': '6.9', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'A 50%: 6 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.2', 'ciLowerLimit': '12.5', 'ciUpperLimit': '21.2', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: At birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.8', 'ciLowerLimit': '8.6', 'ciUpperLimit': '19.1', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 1 Month after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.7', 'ciLowerLimit': '11.9', 'ciUpperLimit': '26.2', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 2 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.0', 'ciLowerLimit': '5.7', 'ciUpperLimit': '14.4', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 4 Months after birth', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.2', 'ciLowerLimit': '3.9', 'ciUpperLimit': '9.9', 'estimateComment': 'GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).', 'groupDescription': 'B 50%: 6 Months after birth', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At birth and at 1, 2, 4, 6 months after birth', 'description': 'GMT of the 50% RSV A and RSV B neutralizing antibody were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% CI was based on the Student t distribution. GMRs of the RSV vaccine group to the placebo group for the RSV A and RSV B neutralizing antibody titers at each time point was calculated and reported in statistical analysis.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Infant evaluable immunogenicity population: eligible infant participants born to maternal participants who received randomized vaccine and had no protocol deviation before delivery, had blood collection within protocol-specified time point at birth, had at least 1 valid, determinate assay result at birth and had no other major protocol deviations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Maternal Participants: RSVpreF 120 mcg', 'description': 'Maternal participants received a single dose of 0.5 milliliter (mL) as intramuscular injection of Respiratory Syncytial Virus prefusion F (RSVpreF) vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'FG001', 'title': 'Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'FG002', 'title': 'Maternal Participants: RSVpreF 240 mcg', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'FG003', 'title': 'Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'FG004', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'FG005', 'title': 'Infant Participants: RSVpreF 120 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'FG006', 'title': 'Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'FG007', 'title': 'Infant Participants: RSVpreF 240 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'FG008', 'title': 'Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'FG009', 'title': 'Infant Participants: Placebo', 'description': 'Infant participants who were born to maternal participants administered with placebo (normal sterile saline solution) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '117'}, {'groupId': 'FG002', 'numSubjects': '116'}, {'groupId': 'FG003', 'numSubjects': '115'}, {'groupId': 'FG004', 'numSubjects': '117'}, {'groupId': 'FG005', 'numSubjects': '114'}, {'groupId': 'FG006', 'numSubjects': '117'}, {'groupId': 'FG007', 'numSubjects': '113'}, {'groupId': 'FG008', 'numSubjects': '112'}, {'groupId': 'FG009', 'numSubjects': '116'}]}, {'type': 'Safety Set', 'achievements': [{'comment': '1 maternal participant randomized to this arm but not vaccinated. Hence excluded from safety set.', 'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '117'}, {'groupId': 'FG002', 'numSubjects': '116'}, {'comment': '1 maternal participant randomized to this arm but not vaccinated. Hence excluded from safety set.', 'groupId': 'FG003', 'numSubjects': '114'}, {'groupId': 'FG004', 'numSubjects': '117'}, {'groupId': 'FG005', 'numSubjects': '114'}, {'groupId': 'FG006', 'numSubjects': '117'}, {'groupId': 'FG007', 'numSubjects': '113'}, {'groupId': 'FG008', 'numSubjects': '112'}, {'groupId': 'FG009', 'numSubjects': '116'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '107'}, {'groupId': 'FG002', 'numSubjects': '108'}, {'groupId': 'FG003', 'numSubjects': '100'}, {'groupId': 'FG004', 'numSubjects': '99'}, {'groupId': 'FG005', 'numSubjects': '106'}, {'groupId': 'FG006', 'numSubjects': '107'}, {'groupId': 'FG007', 'numSubjects': '108'}, {'groupId': 'FG008', 'numSubjects': '100'}, {'groupId': 'FG009', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '12'}, {'groupId': 'FG009', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '9'}, {'groupId': 'FG009', 'numSubjects': '12'}]}, {'type': 'No Longer Meets Eligibility Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Parent/Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Pregnant maternal participants between 18 to 49 years of age and infants who were born to these maternal participants were enrolled in this study.', 'preAssignmentDetails': '778 maternal participants signed the informed consent form (ICF). 197 participants were screen failures who did not meet criteria and were not enrolled. 581 maternal participants and 572 infants born to maternal participants were randomized into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}, {'value': '117', 'groupId': 'BG006'}, {'value': '113', 'groupId': 'BG007'}, {'value': '112', 'groupId': 'BG008'}, {'value': '116', 'groupId': 'BG009'}, {'value': '1151', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Maternal Participants: RSVpreF 120 mcg', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'BG001', 'title': 'Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'BG002', 'title': 'Maternal Participants: RSVpreF 240 mcg', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'BG003', 'title': 'Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'BG004', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery.'}, {'id': 'BG005', 'title': 'Infant Participants: RSVpreF 120 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'BG006', 'title': 'Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'BG007', 'title': 'Infant Participants: RSVpreF 240 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'BG008', 'title': 'Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide', 'description': 'Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'BG009', 'title': 'Infant Participants: Placebo', 'description': 'Infant participants who were born to maternal participants administered with placebo (normal sterile saline solution) during pregnancy were included. Infant participants were followed up to 12 months after birth.'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': 'Less than or equal to(<=) 18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}, {'value': '117', 'groupId': 'BG006'}, {'value': '113', 'groupId': 'BG007'}, {'value': '112', 'groupId': 'BG008'}, {'value': '116', 'groupId': 'BG009'}, {'value': '572', 'groupId': 'BG010'}]}, {'title': 'Greater than or equal to (>=)18 and <= 49 years', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '579', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}, {'value': '58', 'groupId': 'BG006'}, {'value': '58', 'groupId': 'BG007'}, {'value': '55', 'groupId': 'BG008'}, {'value': '53', 'groupId': 'BG009'}, {'value': '865', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '52', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}, {'value': '55', 'groupId': 'BG007'}, {'value': '57', 'groupId': 'BG008'}, {'value': '63', 'groupId': 'BG009'}, {'value': '286', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}, {'value': '37', 'groupId': 'BG006'}, {'value': '28', 'groupId': 'BG007'}, {'value': '32', 'groupId': 'BG008'}, {'value': '33', 'groupId': 'BG009'}, {'value': '323', 'groupId': 'BG010'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}, {'value': '81', 'groupId': 'BG005'}, {'value': '79', 'groupId': 'BG006'}, {'value': '84', 'groupId': 'BG007'}, {'value': '79', 'groupId': 'BG008'}, {'value': '81', 'groupId': 'BG009'}, {'value': '822', 'groupId': 'BG010'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}]}, {'title': 'Black or African American', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '27', 'groupId': 'BG007'}, {'value': '23', 'groupId': 'BG008'}, {'value': '19', 'groupId': 'BG009'}, {'value': '237', 'groupId': 'BG010'}]}, {'title': 'White', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}, {'value': '79', 'groupId': 'BG005'}, {'value': '86', 'groupId': 'BG006'}, {'value': '82', 'groupId': 'BG007'}, {'value': '84', 'groupId': 'BG008'}, {'value': '89', 'groupId': 'BG009'}, {'value': '859', 'groupId': 'BG010'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '14', 'groupId': 'BG010'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '25', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Maternal safety population included all randomized maternal participants who received investigational product and were analyzed according to the investigational product they received. Infant safety population included all infant participants who were born to vaccinated maternal participants and were analyzed according to the investigational product their mothers received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-23', 'size': 5357160, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-20T16:36', 'hasProtocol': True}, {'date': '2019-11-18', 'size': 5005585, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-20T16:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but the participant and all other study personnel, including the principal investigator, will be blinded.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-20', 'studyFirstSubmitDate': '2019-07-22', 'resultsFirstSubmitDate': '2022-09-20', 'studyFirstSubmitQcDate': '2019-07-22', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-20', 'studyFirstPostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination', 'timeFrame': 'Within 7 days after vaccination', 'description': 'Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\\>) 2.0 to 5.0 cm, moderate: \\>5.0 to 10.0 cm and severe: \\>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. The maximum severity was defined as highest grading of each local reaction within 7 days of vaccination.'}, {'measure': 'Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination', 'timeFrame': 'Within 7 days after vaccination', 'description': 'Systemic events included fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and were recorded by participants in an e-diary. Fever was categorized as: grade 1: mild (\\>=38.0 to 38.4 degrees \\[deg\\] Celsius \\[C\\]), grade 2: moderate (\\>38.4 to 38.9 deg C), grade 3: severe (\\>38.9 to 40.0 deg C) and grade 4 (\\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \\>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. The maximum severity was defined as highest grading of each systemic event within 7 days of vaccination.'}, {'measure': 'Percentage of Maternal Participants With Adverse Events (AEs) Within 1 Month After Vaccination', 'timeFrame': 'Within 1 month after vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.'}, {'measure': 'Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications', 'timeFrame': 'From day of vaccination (Day 1) up to 12 months post-delivery', 'description': "MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Obstetric complications were determined as per the study clinician's judgement."}, {'measure': 'Percentage of Infant Participants With Specific Birth Complications', 'timeFrame': 'At birth', 'description': 'Specific birth complications included clavicle fracture, torticollis, cephalhematoma, premature baby, acute respiratory failure, meconium aspiration syndrome, neonatal pneumothorax, neonatal respiratory depression, neonatal respiratory distress, neonatal respiratory distress syndrome, neonatal respiratory failure, pneumothorax, respiratory distress, transient tachypnea of the newborn and subgaleal hemorrhage. Percentage of participants with any specific birth complications were reported in this outcome measure.'}, {'measure': 'Percentage of Infant Participants With Any AE Within 1 Month of Age', 'timeFrame': 'Within 1 month after birth', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.'}, {'measure': 'Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age', 'timeFrame': 'Within 12 months after birth', 'description': 'MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.'}, {'measure': 'Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay', 'timeFrame': 'Within 12 months after birth', 'description': "AEs of special interest for infant participants included congenital anomalies and developmental delays. Congenital anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life. Severity was assessed based on the study investigator's judgement and graded as grade 1= mild (does not interfere with participant's usual function); grade 2= moderate (interferes to some extent with participant's usual function); grade 3= severe (interferes significantly with participant's usual function) and grade 4= life-threatening (life-threatening consequences; urgent intervention indicated). Percentage of infant participants with AEs of special interest of at least moderate severity were presented."}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants', 'timeFrame': 'Before vaccination, 2 weeks and 1 month after vaccination and at delivery', 'description': 'GMT of the 50% RSV A and RSV B neutralizing antibody were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student t distribution. Geometric mean ratios (GMRs) of the RSV vaccine group to the placebo group for the RSV A and RSV B neutralizing antibody titers at each time point was calculated and reported in statistical analysis.'}, {'measure': 'Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants', 'timeFrame': '2 weeks and 1 month after vaccination, at delivery', 'description': 'GMFRs for RSV A and RSV B neutralizing antibody titers from before vaccination to each available time point after vaccination were calculated by exponentiating the mean logarithm of the fold rises. Corresponding 95% CI was based on the Student t distribution. Data for this outcome measure was planned to be analyzed for maternal participants only.'}, {'measure': 'Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants', 'timeFrame': 'At birth and at 1, 2, 4, 6 months after birth', 'description': 'GMT of the 50% RSV A and RSV B neutralizing antibody were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% CI was based on the Student t distribution. GMRs of the RSV vaccine group to the placebo group for the RSV A and RSV B neutralizing antibody titers at each time point was calculated and reported in statistical analysis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory tract infection', 'Respiratory Syncytial Virus', 'RSV', 'Vaccine'], 'conditions': ['Respiratory Tract Infection']}, 'referencesModule': {'references': [{'pmid': '35476650', 'type': 'DERIVED', 'citation': 'Simoes EAF, Center KJ, Tita ATN, Swanson KA, Radley D, Houghton J, McGrory SB, Gomme E, Anderson M, Roberts JP, Scott DA, Jansen KU, Gruber WC, Dormitzer PR, Gurtman AC. Prefusion F Protein-Based Respiratory Syncytial Virus Immunization in Pregnancy. N Engl J Med. 2022 Apr 28;386(17):1615-1626. doi: 10.1056/NEJMoa2106062.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C3671003', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, and investigate safety and characteristics of antibodies in their infants.', 'detailedDescription': 'This Phase 2b, multicenter, randomized, placebo-controlled study will evaluate the safety, tolerability, and immunogenicity of a respiratory syncytial virus stabilized prefusion F subunit vaccine (RSV vaccine) in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, as well as assess safety and characteristics of transplacentally transferred antibodies in their infants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Healthy women 18 to 49 years of age who are between 24 and 36 weeks of gestation on the day of planned vaccination, with an uncomplicated pregnancy, who are at no known increased risk for complications, and whose fetus has no significant abnormalities observed on ultrasound', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria - Maternal participants:\n\n* Healthy women 18 to 49 years of age between 24 and 36 weeks of gestation on the day of planned vaccination, with an uncomplicated pregnancy, who are at no known increased risk for complications, and whose fetus has no significant abnormalities observed on ultrasound.\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Receiving prenatal standard of care.\n* Had an ultrasound performed at \\>=18 weeks of pregnancy.\n* Had a negative urinalysis for protein and glucose at the screening visit. Trace protein in the urine is acceptable if the blood pressure is also normal.\n* Determined by medical history, physical examination, screening laboratory assessment, and clinical judgment to be appropriate for inclusion in the study.\n* Documented negative human immunodeficiency virus antibody, hepatitis B virus surface antigen, hepatitis C virus antibody, and syphilis tests at the screening visit.\n* Body mass index of \\</=40 kg/m2 at the time of the screening visit.\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document and in this protocol.\n* Expected to be available for the duration of the study and willing to give informed consent for her infant to participate in the study.\n\nInclusion Criteria - Infant Participants:\n\n* Evidence of a signed and dated ICD signed by the parent(s).\n* Parent(s) willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria - Maternal Participants:\n\n* Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.\n* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the investigational product or any related vaccine.\n* History of latex allergy.\n* History of any severe allergic reaction.\n* Participants with known or suspected immunodeficiency.\n* Current pregnancy resulting from in vitro fertilization or other assisted reproductive technology.\n* A prior history of or known current pregnancy complications or abnormalities that will increase the risk associated with the participant's participation in and completion of the study.\n* Major illness of the mother or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in, and completion of, the study or could preclude the evaluation of the participant's response.\n* Participant with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention including but not limited to systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1).\n* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.\n* Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.\n* Participants who receive treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids (such as for cancer or an autoimmune disease), or planned receipt of such treatment or agents during study participation. If systemic corticosteroids have been administered short term (\\<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 30 days before investigational product administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.\n* Current alcohol abuse or illicit drug use.\n* Receipt of blood or plasma products or immunoglobulin, from 60 days before investigational product administration, or planned receipt through delivery, with 1 exception, Rho(D) immune globulin (eg, RhoGAM), which can be given at any time.\n* Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.\n* Laboratory test results at the screening visit outside the normal reference value for pregnant women according to their trimester in pregnancy.\n* Participants who are breastfeeding at the time of the screening visit.\n\nExclusion Criteria - Infant Participants:\n\n• Infant who is a direct descendant (eg, child or grandchild) of the study personnel."}, 'identificationModule': {'nctId': 'NCT04032093', 'briefTitle': 'A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 2B, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE AND THEIR INFANTS', 'orgStudyIdInfo': {'id': 'C3671003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RSV dose with aluminum hydroxide', 'description': 'RSV vaccine with aluminum hydroxide', 'interventionNames': ['Biological: RSV vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'RSV dose without aluminum hydroxide', 'description': 'RSV vaccine without aluminum hydroxide', 'interventionNames': ['Biological: RSV vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Higher RSV dose with aluminum hydroxide', 'description': 'Higher dose level RSV vaccine with aluminum hydroxide', 'interventionNames': ['Biological: RSV vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Higher RSV dose without aluminum hydroxide', 'description': 'Higher dose level RSV vaccine without aluminum hydroxide', 'interventionNames': ['Biological: RSV vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo dose', 'description': 'Normal saline solution for injection (0.9% sodium chloride injection)', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'RSV vaccine', 'type': 'BIOLOGICAL', 'description': 'RSV vaccine', 'armGroupLabels': ['Higher RSV dose with aluminum hydroxide', 'Higher RSV dose without aluminum hydroxide', 'RSV dose with aluminum hydroxide', 'RSV dose without aluminum hydroxide']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Normal saline solution for injection (0.9% sodium chloride injection)', 'armGroupLabels': ['Placebo dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Women & Infants Center - 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