Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 11:44 PM
Study NCT ID:
NCT04754594
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2021-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090982', 'term': 'BNT162 Vaccine'}], 'ancestors': [{'id': 'D000087503', 'term': 'mRNA Vaccines'}, {'id': 'D000087504', 'term': 'Nucleic Acid-Based Vaccines'}, {'id': 'D014614', 'term': 'Vaccines, Synthetic'}, {'id': 'D011994', 'term': 'Recombinant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000086663', 'term': 'COVID-19 Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'patients@biontech.de', 'phone': '+49 6131 9084', 'title': 'BioNTech clinical trials patient information', 'phoneExt': '0', 'organization': 'BioNTech SE'}, 'certainAgreement': {'otherDetails': 'The sponsor (or its agents) has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication 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': 'Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age', 'description': 'Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Maternal Participants: BNT162b2 30 mcg (Blinded Phase)', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery. HIV positive maternal participants were excluded.', 'otherNumAtRisk': 161, 'deathsNumAtRisk': 161, 'otherNumAffected': 143, 'seriousNumAtRisk': 161, 'deathsNumAffected': 0, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Maternal Participants: Placebo (Blinded Phase)', 'description': 'Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. HIV positive maternal participants were excluded.', 'otherNumAtRisk': 163, 'deathsNumAtRisk': 163, 'otherNumAffected': 119, 'seriousNumAtRisk': 163, 'deathsNumAffected': 0, 'seriousNumAffected': 23}, {'id': 'EG002', 'title': 'Maternal Participants: Placebo Then BNT162b2 (Unblinded Phase)', 'description': 'Participants who originally received 2 doses of blinded placebo were administered 2 doses of 30 mcg BNT162b2 vaccine as intramuscular injection separated by 21 days after unblinding at 1 month post-delivery. Participants were followed-up until 1 month after last vaccination. HIV positive maternal participants were excluded.', 'otherNumAtRisk': 144, 'deathsNumAtRisk': 144, 'otherNumAffected': 21, 'seriousNumAtRisk': 144, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Infant Participants: BNT162b2 30 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age. HIV positive infant participants born to HIV positive maternal participants were excluded.', 'otherNumAtRisk': 156, 'deathsNumAtRisk': 156, 'otherNumAffected': 29, 'seriousNumAtRisk': 156, 'deathsNumAffected': 0, 'seriousNumAffected': 21}, {'id': 'EG004', 'title': 'Infant Participants: Placebo', 'description': 'Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age. HIV positive infant participants born to HIV positive maternal participants were excluded.', 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 33, 'seriousNumAtRisk': 159, 'deathsNumAffected': 1, 'seriousNumAffected': 24}, {'id': 'EG005', 'title': 'HIV Positive Maternal Participants: BNT162b2 30 mcg (Blinded Phase)', 'description': 'Maternal participants who were HIV positive received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'HIV Positive Maternal Participants: Placebo (Blinded Phase)', 'description': 'Maternal participants who were HIV positive received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG007', 'title': 'HIV Positive Maternal Participants: Placebo Then BNT162b2 (Unblinded Phase)', 'description': 'HIV positive maternal participants who originally received 2 doses of blinded placebo were administered 2 doses of 30 mcg BNT162b2 vaccine as intramuscular injection separated by 21 days after unblinding at 1 month post-delivery. Participants were followed-up until 1 month after last vaccination.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'HIV Positive Infant Participants: BNT162b2 30 mcg', 'description': 'Infant participants who were born to HIV positive maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG009', 'title': 'HIV Positive Infant Participants: Placebo', 'description': 'Infant participants who were born to HIV positive maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Diarrhea (DIARRHEA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Vomiting (VOMITING)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Chills (CHILLS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Erythema (REDNESS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Fatigue (FATIGUE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Injection site pain (PAIN AT INJECTION SITE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pyrexia (FEVER)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Swelling (SWELLING)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Amniotic cavity infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Streptococcus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 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'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Failed trial of labor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Fetal death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Superior sagittal sinus thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.'}], 'classes': [{'title': 'Redness: Mild', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '6.2'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.4'}]}]}, {'title': 'Redness: Moderate', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Redness: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Redness: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Swelling: Mild', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '8.8'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Swelling: Moderate', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Swelling: Severe', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Swelling: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Pain at the injection site: Mild', 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG000', 'lowerLimit': '51.0', 'upperLimit': '66.7'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '15.5'}]}]}, {'title': 'Pain at the injection site: Moderate', 'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000', 'lowerLimit': '17.3', 'upperLimit': '30.9'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Pain at the injection site: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Pain at the injection site: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 7 after dose 1', 'description': 'Pain at injection site, redness \\& swelling were recorded by participants in an electronic diary (e-diary). Redness \\& swelling were measured \\& recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm \\& graded as mild: \\> 2.0 to 5.0 cm, moderate: \\> 5.0 to 10.0 cm, severe: \\> 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) \\& necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity \\& grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Reactions reported as adverse events in the case report form within 7 days after the study vaccination were also included in the analysis. Exact 2-sided 95% confidence interval (CI) was based on Clopper \\& Pearson method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" (N) signifies participants evaluable for this outcome measure. Human immunodeficiency virus (HIV) positive participants were excluded from analysis as pre-specified in the statistical analysis plan (SAP).'}, {'type': 'PRIMARY', 'title': 'Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.'}], 'classes': [{'title': 'Redness: Mild', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '7.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Redness: Moderate', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '5.8'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Redness: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Redness: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Swelling: Mild', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '8.6'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.8'}]}]}, {'title': 'Swelling: Moderate', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '6.8'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Swelling: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Swelling: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Pain at the injection site: Mild', 'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000', 'lowerLimit': '46.3', 'upperLimit': '62.9'}, {'value': '12.3', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '18.8'}]}]}, {'title': 'Pain at the injection site: Moderate', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000', 'lowerLimit': '13.5', 'upperLimit': '26.9'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '8.7'}]}]}, {'title': 'Pain at the injection site: Severe', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Pain at the injection site: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 7 after dose 2', 'description': 'Pain at injection site, redness \\& swelling were recorded by participants in an e-diary. Redness \\& swelling were measured \\& recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm \\& graded as mild: \\> 2.0 to 5.0 cm, moderate: \\> 5.0 to 10.0 cm, severe: \\> 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) \\& necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity \\& grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Reactions reported as adverse events (AEs) in the case report form (CRF) within 7 days after the study vaccination were also included in the analysis. Exact 2-sided 95% CI was based on the Clopper \\& Pearson method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.'}, {'type': 'PRIMARY', 'title': 'Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.'}], 'classes': [{'title': 'Fever: >=38.0 to 38.4 deg C (100.4 to 101.1 deg Fahrenheit [F])', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '4.4'}]}]}, {'title': 'Fever: >38.4 to 38.9 deg C (101.2 to 102.0 deg F)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Fever: >38.9 to 40.0 deg C (102.1 to 104.0 deg F)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.4'}]}]}, {'title': 'Fever: >40 deg C (>104.0 deg F)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Fatigue/tiredness: Mild', 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000', 'lowerLimit': '19.5', 'upperLimit': '33.6'}, {'value': '20.9', 'groupId': 'OG001', 'lowerLimit': '14.9', 'upperLimit': '27.9'}]}]}, {'title': 'Fatigue/tiredness: Moderate', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '30.3'}, {'value': '21.5', 'groupId': 'OG001', 'lowerLimit': '15.4', 'upperLimit': '28.6'}]}]}, {'title': 'Fatigue/tiredness: Severe', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.4'}]}]}, {'title': 'Fatigue/tiredness: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Headache: Mild', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '14.5', 'upperLimit': '27.6'}, {'value': '22.1', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '29.2'}]}]}, {'title': 'Headache: Moderate', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '17.8'}, {'value': '12.9', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '19.0'}]}]}, {'title': 'Headache: Severe', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '5.3'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.4'}]}]}, {'title': 'Headache: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Chills: Mild', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '9.6'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '10.2'}]}]}, {'title': 'Chills: Moderate', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '5.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Chills: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Chills: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Vomiting: Mild', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '9.6'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '11.0'}]}]}, {'title': 'Vomiting: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Vomiting: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Vomiting: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Diarrhea: Mild', 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '17.1'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '12.5'}]}]}, {'title': 'Diarrhea: Moderate', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '4.4'}]}]}, {'title': 'Diarrhea: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'Diarrhea: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'New or worsened muscle pain: Mild', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '11.9'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '11.0'}]}]}, {'title': 'New or worsened muscle pain: Moderate', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '10.3'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '10.2'}]}]}, {'title': 'New or worsened muscle pain: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'New or worsened muscle pain: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'New or worsened joint pain: Mild', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '4.4'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '6.2'}]}]}, {'title': 'New or worsened joint pain: Moderate', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '5.3'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '6.2'}]}]}, {'title': 'New or worsened joint pain: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'New or worsened joint pain: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 7 after dose 1', 'description': 'Systemic events were recorded by participants in an e-diary. Fever was oral temperature \\>= 38 degree Celsius (°C) \\& categorized as \\>=38.0 to 38.4 °C, \\>38.4 to 38.9 °C, \\>38.9 to 40.0 °C \\& \\>40.0 °C. Fatigue, headache, chills, new or worsened muscle pain \\& new or worsened joint pain were graded mild: did not interfere with activity, moderate: some interference with activity \\& severe: prevented daily routine activity. Vomiting was graded mild: 1 to 2 times in 24 hours (h), moderate: \\>2 times in 24h \\& severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h \\& severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also included in analysis. Exact 95% CI was based on Clopper \\& Pearson method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.'}, {'type': 'PRIMARY', 'title': 'Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.'}], 'classes': [{'title': 'Fever: >=38.0 to 38.4 deg C (100.4 to 101.1 deg F)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '4.8'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.8'}]}]}, {'title': 'Fever: >38.4 to 38.9 deg C (101.2 to 102.0 deg F)', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Fever: >38.9 to 40.0 deg C (102.1 to 104.0 deg F)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Fever: >40 deg C (>104.0 deg F)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Fatigue/tiredness: Mild', 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '22.4'}, {'value': '15.8', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '22.7'}]}]}, {'title': 'Fatigue/tiredness: Moderate', 'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000', 'lowerLimit': '25.0', 'upperLimit': '40.6'}, {'value': '18.5', 'groupId': 'OG001', 'lowerLimit': '12.6', 'upperLimit': '25.8'}]}]}, {'title': 'Fatigue/tiredness: Severe', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '5.8'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Fatigue/tiredness: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Headache: Mild', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '18.3', 'upperLimit': '32.8'}, {'value': '13.7', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '20.4'}]}]}, {'title': 'Headache: Moderate', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '21.6'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '16.4'}]}]}, {'title': 'Headache: Severe', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '4.8'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Headache: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Chills: Mild', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '9.5'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.8'}]}]}, {'title': 'Chills: Moderate', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '12.9'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Chills: Severe', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Chills: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Vomiting: Mild', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '14.6'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '5.9'}]}]}, {'title': 'Vomiting: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '4.9'}]}]}, {'title': 'Vomiting: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Vomiting: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Diarrhea: Mild', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '11.2'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '8.7'}]}]}, {'title': 'Diarrhea: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '4.9'}]}]}, {'title': 'Diarrhea: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Diarrhea: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'New or worsened muscle pain: Mild', 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '20.1'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '9.6'}]}]}, {'title': 'New or worsened muscle pain: Moderate', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '19.3'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '5.9'}]}]}, {'title': 'New or worsened muscle pain: Severe', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'New or worsened muscle pain: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'New or worsened joint pain: Mild', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '12.9'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '9.6'}]}]}, {'title': 'New or worsened joint pain: Moderate', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '11.2'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '4.9'}]}]}, {'title': 'New or worsened joint pain: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'New or worsened joint pain: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 7 after dose 2', 'description': 'Systemic events were recorded by participants in an e-diary. Fever was oral temperature \\>= 38 °C \\& categorized as \\>=38.0 to 38.4 °C, \\>38.4 to 38.9 °C, \\>38.9 to 40.0 °C \\& \\>40.0 °C. Fatigue, headache, chills, new or worsened muscle pain \\& new or worsened joint pain were graded mild: did not interfere with activity, moderate: some interference with activity \\& severe: prevented daily routine activity. Vomiting was graded mild: 1 to 2 times in 24 h, moderate: \\>2 times in 24 h \\& severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24 h, moderate: 4 to 5 loose stools in 24 h \\& severe: 6 or more loose stools in 24 h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also included in analysis. Exact 95% CI was based on Clopper \\& Pearson method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.'}, {'type': 'PRIMARY', 'title': 'Percentage of Maternal Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000', 'lowerLimit': '17.3', 'upperLimit': '30.9'}, {'value': '22.7', 'groupId': 'OG001', 'lowerLimit': '16.5', 'upperLimit': '29.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From dose 1 on Day 1 through 1 month after dose 2 (approximately 2 months)', 'description': 'An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.'}, {'type': 'PRIMARY', 'title': 'Percentage of Maternal Participants Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '19.2'}, {'value': '14.1', 'groupId': 'OG001', 'lowerLimit': '9.2', 'upperLimit': '20.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From dose 1 on Day 1 through 1 month after delivery (up to 22 weeks)', 'description': 'An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Ratio (GMR) of the SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population Without Evidence of Prior SARS-CoV-2 Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days.'}, {'id': 'OG001', 'title': 'Non-Pregnant Participants: Study C4591001', 'description': 'Non-pregnant participants who received two doses of BNT162b2 30 mcg as an intramuscular injection separated by 21 days in study C4591001 (NCT04368728).'}], 'classes': [{'categories': [{'measurements': [{'value': '1109.2', 'groupId': 'OG000', 'lowerLimit': '849.2', 'upperLimit': '1448.9'}, {'value': '1663.7', 'groupId': 'OG001', 'lowerLimit': '1411.5', 'upperLimit': '1960.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.50', 'ciUpperLimit': '0.90', 'groupDescription': 'GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 Month after Dose 2', 'description': 'GMR of SARS-CoV-2 neutralizing titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable immunogenicity population without evidence of prior SARS-CoV-2 infection up to 1 month after Dose 2 was reported in this outcome measure. Geometric mean titer (GMT) and 2-sided 95% CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on student t distribution) and was reported in descriptive section. GMR was reported in statistical analysis section of this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of vaccine to which they were randomized, with Dose 2 received within predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population without evidence of SARS-CoV2 infection up to 1 month after Dose 2 was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.'}, {'type': 'PRIMARY', 'title': 'GMR of SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population With and Without Evidence of Prior SARS-CoV-2 Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days.'}, {'id': 'OG001', 'title': 'Non-Pregnant Participants: Study C4591001', 'description': 'Non-pregnant participants who received two doses of BNT162b2 30 mcg as an intramuscular injection separated by 21 days in study C4591001 (NCT04368728).'}], 'classes': [{'categories': [{'measurements': [{'value': '2198.7', 'groupId': 'OG000', 'lowerLimit': '1618.5', 'upperLimit': '2987.0'}, {'value': '1732.0', 'groupId': 'OG001', 'lowerLimit': '1469.4', 'upperLimit': '2041.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.77', 'groupDescription': 'GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.30', 'groupDescription': 'GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 Month after Dose 2', 'description': 'GMR of SARS-CoV-2 neutralizing titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable immunogenicity population with and without evidence of prior SARS-CoV-2 infection was reported in this outcome measure. GMT and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the student t distribution) and was reported in the descriptive section. GMR was reported in the statistical analysis section. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.'}, {'type': 'SECONDARY', 'title': 'COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.'}, {'id': 'OG001', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.903', 'groupId': 'OG000'}, {'value': '13.423', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.8', 'ciLowerLimit': '-1227.8', 'ciUpperLimit': '93.0', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Vaccine efficacy was estimated by 100\\*(1 - illness rate ratio \\[IRR\\]), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.'}], 'paramType': 'NUMBER', 'timeFrame': 'From 7 days after Dose 2 up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.155, Placebo- 0.149)', 'description': 'COVID-19 incidence per 100 person-years of blinded follow-up in evaluable maternal participants without evidence of prior SARS-CoV-2 infection prior to 7 days after receipt of Dose 2 was reported in this outcome measure.', 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable efficacy population included all eligible randomized participants who received all vaccinations as randomized, with Dose 2 received within predefined window (within 19-42 days after Dose 1) and had no other important protocol deviations as determined by clinician on or before 7 days after Dose 2. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in SAP.'}, {'type': 'SECONDARY', 'title': 'COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants With or Without Evidence of Prior SARS-CoV-2 Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.407', 'groupId': 'OG000'}, {'value': '11.407', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.1', 'ciLowerLimit': '-466.5', 'ciUpperLimit': '94.6', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Vaccine efficacy was estimated by 100\\*(1 - IRR), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.'}], 'paramType': 'NUMBER', 'timeFrame': 'From 7 days after Dose 2 up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.270, Placebo- 0.263)', 'description': 'COVID-19 incidence per 100 person-years of blinded follow-up in evaluable maternal participants with or without evidence of prior SARS-CoV-2 infection was reported in this outcome measure.', 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable efficacy population included all eligible randomized participants who received all vaccinations as randomized, with Dose 2 received within predefined window (within 19-42 days after Dose 1) and had no other important protocol deviations as determined by clinician on or before 7 days after Dose 2. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in SAP.'}, {'type': 'SECONDARY', 'title': 'Incidence of Asymptomatic Infection of SARS-CoV-2 Through 1 Month After Delivery in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.404', 'groupId': 'OG000'}, {'value': '68.027', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.9', 'ciLowerLimit': '-104.9', 'ciUpperLimit': '86.5', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Vaccine efficacy was estimated by 100\\*(1 - IRR), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.099, Placebo- 0.147)', 'description': 'Incidence of asymptomatic infection of SARS-CoV-2 through 1 month after delivery in evaluable maternal participants without evidence of prior SARS-CoV-2 infection prior to the first post-dose 2 N-binding test was reported in this outcome measure.', 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable efficacy population included all eligible randomized participants who received all vaccinations as randomized, with Dose 2 received within predefined window (within 19-42 days after Dose 1) and had no other important protocol deviations as determined by clinician on or before 7 days after Dose 2. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in SAP.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.'}], 'classes': [{'title': 'Before Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '3.7'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '2.8'}]}]}, {'title': '2 weeks after Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7802.0', 'groupId': 'OG000', 'lowerLimit': '6273.3', 'upperLimit': '9703.2'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '3.1'}]}]}, {'title': '1 month after Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4281.0', 'groupId': 'OG000', 'lowerLimit': '3234.7', 'upperLimit': '5665.7'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '2.9'}]}]}, {'title': 'At delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2747.6', 'groupId': 'OG000', 'lowerLimit': '2144.7', 'upperLimit': '3520.0'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}, {'title': '6 months after delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1639.4', 'groupId': 'OG000', 'lowerLimit': '780.1', 'upperLimit': '3445.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery', 'description': 'GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ. GMCs of full-length S-binding IgG levels in evaluable maternal participants at baseline, 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.', 'unitOfMeasure': 'Units/milliliter (U/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and \'Number Analyzed\' signifies participants evaluable for the specified rows. HIV positive participants were excluded from analysis as pre-specified in the SAP.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.'}], 'classes': [{'title': 'Before Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000', 'lowerLimit': '41.6', 'upperLimit': '54.4'}, {'value': '43.5', 'groupId': 'OG001', 'lowerLimit': '43.5', 'upperLimit': '43.5'}]}]}, {'title': '2 weeks after Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1991.8', 'groupId': 'OG000', 'lowerLimit': '1456.3', 'upperLimit': '2724.1'}, {'value': '45.0', 'groupId': 'OG001', 'lowerLimit': '42.0', 'upperLimit': '48.3'}]}]}, {'title': '1 month after Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1212.6', 'groupId': 'OG000', 'lowerLimit': '855.2', 'upperLimit': '1719.4'}, {'value': '43.5', 'groupId': 'OG001', 'lowerLimit': '43.5', 'upperLimit': '43.5'}]}]}, {'title': 'At delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '695.7', 'groupId': 'OG000', 'lowerLimit': '500.6', 'upperLimit': '966.8'}, {'value': '43.5', 'groupId': 'OG001', 'lowerLimit': '43.5', 'upperLimit': '43.5'}]}]}, {'title': '6 months after delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '465.4', 'groupId': 'OG000', 'lowerLimit': '168.6', 'upperLimit': '1284.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery', 'description': 'GMTs, and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ. GMTs of SARS-CoV-2 neutralizing titers in evaluable maternal participants at baseline, 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and \'Number Analyzed\' signifies participants evaluable for the specified rows. HIV positive participants were excluded from analysis as pre-specified in the SAP.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.'}], 'classes': [{'title': '2 weeks after Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3618.7', 'groupId': 'OG000', 'lowerLimit': '2489.1', 'upperLimit': '5260.7'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.1'}]}]}, {'title': '1 month after Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2276.4', 'groupId': 'OG000', 'lowerLimit': '1545.5', 'upperLimit': '3352.9'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.1'}]}]}, {'title': 'At delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1377.6', 'groupId': 'OG000', 'lowerLimit': '948.6', 'upperLimit': '2000.5'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '1.0'}]}]}, {'title': '6 months after delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '650.3', 'groupId': 'OG000', 'lowerLimit': '279.3', 'upperLimit': '1514.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From before dose 1 up to 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery', 'description': 'GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ. GMFR from before vaccination to each subsequent time point after vaccination for full-length S-binding IgG levels in evaluable maternal participants at 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.', 'unitOfMeasure': 'Fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and \'Number Analyzed\' signifies participants evaluable for the specified rows. HIV positive participants were excluded from analysis as pre-specified in the SAP.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maternal Participants: BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.'}, {'id': 'OG001', 'title': 'Maternal Participants: Placebo', 'description': 'Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.'}], 'classes': [{'title': '2 weeks after Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.7', 'groupId': 'OG000', 'lowerLimit': '33.9', 'upperLimit': '56.4'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.1'}]}]}, {'title': '1 month after Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000', 'lowerLimit': '18.9', 'upperLimit': '33.9'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.0'}]}]}, {'title': 'At delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '20.1'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.0'}]}]}, {'title': '6 months after delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '25.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From before dose 1 up to 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery', 'description': 'GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ. GMFR from before vaccination to each subsequent time point after vaccination for SARS-CoV-2 neutralizing titers in evaluable maternal participants at 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.', 'unitOfMeasure': 'Fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and \'Number Analyzed\' signifies participants evaluable for the specified rows. HIV positive participants were excluded from analysis as pre-specified in the SAP.'}, {'type': 'SECONDARY', 'title': 'Percentage of Infant Participants Reporting Specific Birth Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infant Participants: BNT162b2 30 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.'}, {'id': 'OG001', 'title': 'Infant Participants: Placebo', 'description': 'Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '91.6', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '95.3'}, {'value': '89.3', 'groupId': 'OG001', 'lowerLimit': '83.6', 'upperLimit': '93.5'}]}]}, {'title': 'Congenital malformation/anomaly', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '10.7'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '7.6'}]}]}, {'title': 'Other neonatal problem', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '5.2'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '11.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At birth', 'description': 'Percentage of infant participants reporting specific birth outcomes (normal, congenital malformation/anomaly, other neonatal problems) were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population for infant participants included all infant participants born to maternal participants who received at least 1 dose of the study intervention. As this outcome measure was measured at birth, HIV positive infant participants were included in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Infant Participants Reporting Adverse Events From Birth Through 1 Month of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infant Participants: BNT162b2 30 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.'}, {'id': 'OG001', 'title': 'Infant Participants: Placebo', 'description': 'Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'groupId': 'OG000', 'lowerLimit': '27.8', 'upperLimit': '43.3'}, {'value': '37.1', 'groupId': 'OG001', 'lowerLimit': '29.6', 'upperLimit': '45.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From birth through 1 month of age', 'description': 'An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population for infant participants included all infant participants born to maternal participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.'}, {'type': 'SECONDARY', 'title': 'Percentage of Infant Participants Reporting Serious Adverse Events (SAE) From Birth Through 6 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infant Participants: BNT162b2 30 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.'}, {'id': 'OG001', 'title': 'Infant Participants: Placebo', 'description': 'Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '19.8'}, {'value': '15.1', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '21.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From birth through 6 months of age', 'description': 'An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population for infant participants included all infant participants born to maternal participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.'}, {'type': 'SECONDARY', 'title': 'Percentage of Infant Participants Reporting Adverse Event of Special Interest (AESI) From Birth Through 6 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infant Participants: BNT162b2 30 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.'}, {'id': 'OG001', 'title': 'Infant Participants: Placebo', 'description': 'Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '9.9'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '4.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From birth through 6 months of age', 'description': 'Percentage of infant participants who reported AESI including major congenital anomalies and developmental delay from birth through 6 months of age were reported in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population for infant participants included all infant participants born to maternal participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.'}, {'type': 'SECONDARY', 'title': 'GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infant Participants: BNT162b2 30 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.'}, {'id': 'OG001', 'title': 'Infant Participants: Placebo', 'description': 'Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.'}], 'classes': [{'title': 'At Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5576.4', 'groupId': 'OG000', 'lowerLimit': '4246.2', 'upperLimit': '7323.2'}, {'value': '19.4', 'groupId': 'OG001', 'lowerLimit': '10.2', 'upperLimit': '37.0'}]}]}, {'title': '6 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '311.1', 'groupId': 'OG000', 'lowerLimit': '235.8', 'upperLimit': '410.5'}, {'value': '22.0', 'groupId': 'OG001', 'lowerLimit': '11.4', 'upperLimit': '42.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At birth and 6 months of age', 'description': 'GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ. GMCs of full-length S-binding IgG levels at birth and 6 months of age in infant participants born to evaluable maternal participants was reported in this outcome measure.', 'unitOfMeasure': 'Units/milliliter (U/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All infant participants born to evaluable immunogenicity maternal participants and had no important protocol deviations as determined by the clinician. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and \'Number Analyzed\' signifies participants evaluable for the specified rows. HIV positive participants were excluded from analysis as pre-specified in the SAP.'}, {'type': 'SECONDARY', 'title': 'GMFR of Full-Length S-Binding IgG Levels From Birth to 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infant Participants: BNT162b2 30 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.'}, {'id': 'OG001', 'title': 'Infant Participants: Placebo', 'description': 'Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.1'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '1.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From birth to 6 months of age', 'description': 'GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ. GMFR of full-length S-binding IgG levels from birth to 6 months of age in infant participants born to evaluable maternal participants was reported in this outcome measure.', 'unitOfMeasure': 'Fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All infant participants born to evaluable immunogenicity maternal participants and had no important protocol deviations as determined by the clinician. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Maternal Participants: BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.'}, {'id': 'FG001', 'title': 'Maternal Participants: Placebo Then BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. After unblinding at 1 month post-delivery, participants were administered 2 doses of BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed-up until 1 month after last dose of vaccination.'}, {'id': 'FG002', 'title': 'Infant Participants: BNT162b2 30 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.'}, {'id': 'FG003', 'title': 'Infant Participants: Placebo', 'description': 'Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.'}], 'periods': [{'title': 'Blinded Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '174'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Vaccination 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '173'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Vaccination 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '170'}, {'groupId': 'FG001', 'numSubjects': '170'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '159'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Unblinded before 1-month postdelivery visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Unblinded Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '6 participants unblinded before 1-month post delivery are also included.', 'groupId': 'FG000', 'numSubjects': '167'}, {'comment': '3 participants unblinded before 1-month post delivery are also included.', 'groupId': 'FG001', 'numSubjects': '162'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Vaccination 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '152'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Vaccination 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '148'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '147'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Infant Participants', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '167'}, {'groupId': 'FG003', 'numSubjects': '168'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '152'}, {'groupId': 'FG003', 'numSubjects': '139'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted in 2 periods-Blinded Period (from Day 1 to 1 month post-delivery) and Unblinded Period (1 to 6 Months Post-Delivery for those maternal participants who initially received BNT162b2 and from first dose of BNT162b2 to 1 month after second dose of BNT162b2 for those maternal participants who initially received placebo).', 'preAssignmentDetails': 'A total of 726 participants were enrolled in this study. 391 were maternal participants who signed informed consent form and were enrolled out of which 41 were screen failures and 2 participants were not randomized. Eventually 348 maternal participants were randomized to receive treatment. 335 were infants born to maternal participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}, {'value': '168', 'groupId': 'BG003'}, {'value': '681', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Maternal Participants: BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.'}, {'id': 'BG001', 'title': 'Maternal Participants: Placebo Then BNT162b2 30 mcg', 'description': 'Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. After unblinding at 1 month post-delivery, participants were administered 2 doses of BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed-up until 1 month after last dose of vaccination.'}, {'id': 'BG002', 'title': 'Infant Participants: BNT162b2 30 mcg', 'description': 'Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.'}, {'id': 'BG003', 'title': 'Infant Participants: Placebo', 'description': 'Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': 'Less than (<) 18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}, {'value': '168', 'groupId': 'BG003'}, {'value': '335', 'groupId': 'BG004'}]}, {'title': 'Greater than or equal to (>=) 18 and <= 45 years', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '346', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}, {'value': '504', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}, {'value': '177', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '258', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}, {'value': '415', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '170', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}, {'value': '454', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. For infant participants, safety population included all infant participants born to maternal participants who received at least 1 dose of the study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-08', 'size': 14281650, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-14T09:06', 'hasProtocol': True}, {'date': '2022-03-31', 'size': 5342453, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-14T09:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 726}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2021-02-09', 'resultsFirstSubmitDate': '2023-07-14', 'studyFirstSubmitQcDate': '2021-02-11', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-22', 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1', 'timeFrame': 'From Day 1 to Day 7 after dose 1', 'description': 'Pain at injection site, redness \\& swelling were recorded by participants in an electronic diary (e-diary). Redness \\& swelling were measured \\& recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm \\& graded as mild: \\> 2.0 to 5.0 cm, moderate: \\> 5.0 to 10.0 cm, severe: \\> 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) \\& necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity \\& grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Reactions reported as adverse events in the case report form within 7 days after the study vaccination were also included in the analysis. Exact 2-sided 95% confidence interval (CI) was based on Clopper \\& Pearson method.'}, {'measure': 'Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2', 'timeFrame': 'From Day 1 to Day 7 after dose 2', 'description': 'Pain at injection site, redness \\& swelling were recorded by participants in an e-diary. Redness \\& swelling were measured \\& recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm \\& graded as mild: \\> 2.0 to 5.0 cm, moderate: \\> 5.0 to 10.0 cm, severe: \\> 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) \\& necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity \\& grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Reactions reported as adverse events (AEs) in the case report form (CRF) within 7 days after the study vaccination were also included in the analysis. Exact 2-sided 95% CI was based on the Clopper \\& Pearson method.'}, {'measure': 'Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1', 'timeFrame': 'From Day 1 to Day 7 after dose 1', 'description': 'Systemic events were recorded by participants in an e-diary. Fever was oral temperature \\>= 38 degree Celsius (°C) \\& categorized as \\>=38.0 to 38.4 °C, \\>38.4 to 38.9 °C, \\>38.9 to 40.0 °C \\& \\>40.0 °C. Fatigue, headache, chills, new or worsened muscle pain \\& new or worsened joint pain were graded mild: did not interfere with activity, moderate: some interference with activity \\& severe: prevented daily routine activity. Vomiting was graded mild: 1 to 2 times in 24 hours (h), moderate: \\>2 times in 24h \\& severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h \\& severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also included in analysis. Exact 95% CI was based on Clopper \\& Pearson method.'}, {'measure': 'Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2', 'timeFrame': 'From Day 1 to Day 7 after dose 2', 'description': 'Systemic events were recorded by participants in an e-diary. Fever was oral temperature \\>= 38 °C \\& categorized as \\>=38.0 to 38.4 °C, \\>38.4 to 38.9 °C, \\>38.9 to 40.0 °C \\& \\>40.0 °C. Fatigue, headache, chills, new or worsened muscle pain \\& new or worsened joint pain were graded mild: did not interfere with activity, moderate: some interference with activity \\& severe: prevented daily routine activity. Vomiting was graded mild: 1 to 2 times in 24 h, moderate: \\>2 times in 24 h \\& severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24 h, moderate: 4 to 5 loose stools in 24 h \\& severe: 6 or more loose stools in 24 h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also included in analysis. Exact 95% CI was based on Clopper \\& Pearson method.'}, {'measure': 'Percentage of Maternal Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period', 'timeFrame': 'From dose 1 on Day 1 through 1 month after dose 2 (approximately 2 months)', 'description': 'An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.'}, {'measure': 'Percentage of Maternal Participants Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period', 'timeFrame': 'From dose 1 on Day 1 through 1 month after delivery (up to 22 weeks)', 'description': 'An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.'}, {'measure': 'Geometric Mean Ratio (GMR) of the SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population Without Evidence of Prior SARS-CoV-2 Infection', 'timeFrame': '1 Month after Dose 2', 'description': 'GMR of SARS-CoV-2 neutralizing titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable immunogenicity population without evidence of prior SARS-CoV-2 infection up to 1 month after Dose 2 was reported in this outcome measure. Geometric mean titer (GMT) and 2-sided 95% CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on student t distribution) and was reported in descriptive section. GMR was reported in statistical analysis section of this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of vaccine to which they were randomized, with Dose 2 received within predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.'}, {'measure': 'GMR of SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population With and Without Evidence of Prior SARS-CoV-2 Infection', 'timeFrame': '1 Month after Dose 2', 'description': 'GMR of SARS-CoV-2 neutralizing titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable immunogenicity population with and without evidence of prior SARS-CoV-2 infection was reported in this outcome measure. GMT and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the student t distribution) and was reported in the descriptive section. GMR was reported in the statistical analysis section. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.'}], 'secondaryOutcomes': [{'measure': 'COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection', 'timeFrame': 'From 7 days after Dose 2 up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.155, Placebo- 0.149)', 'description': 'COVID-19 incidence per 100 person-years of blinded follow-up in evaluable maternal participants without evidence of prior SARS-CoV-2 infection prior to 7 days after receipt of Dose 2 was reported in this outcome measure.'}, {'measure': 'COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants With or Without Evidence of Prior SARS-CoV-2 Infection', 'timeFrame': 'From 7 days after Dose 2 up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.270, Placebo- 0.263)', 'description': 'COVID-19 incidence per 100 person-years of blinded follow-up in evaluable maternal participants with or without evidence of prior SARS-CoV-2 infection was reported in this outcome measure.'}, {'measure': 'Incidence of Asymptomatic Infection of SARS-CoV-2 Through 1 Month After Delivery in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection', 'timeFrame': 'Up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.099, Placebo- 0.147)', 'description': 'Incidence of asymptomatic infection of SARS-CoV-2 through 1 month after delivery in evaluable maternal participants without evidence of prior SARS-CoV-2 infection prior to the first post-dose 2 N-binding test was reported in this outcome measure.'}, {'measure': 'Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants', 'timeFrame': 'Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery', 'description': 'GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ. GMCs of full-length S-binding IgG levels in evaluable maternal participants at baseline, 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.'}, {'measure': 'Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants', 'timeFrame': 'Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery', 'description': 'GMTs, and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ. GMTs of SARS-CoV-2 neutralizing titers in evaluable maternal participants at baseline, 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.'}, {'measure': 'Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants', 'timeFrame': 'From before dose 1 up to 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery', 'description': 'GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ. GMFR from before vaccination to each subsequent time point after vaccination for full-length S-binding IgG levels in evaluable maternal participants at 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.'}, {'measure': 'Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants', 'timeFrame': 'From before dose 1 up to 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery', 'description': 'GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ. GMFR from before vaccination to each subsequent time point after vaccination for SARS-CoV-2 neutralizing titers in evaluable maternal participants at 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.'}, {'measure': 'Percentage of Infant Participants Reporting Specific Birth Outcomes', 'timeFrame': 'At birth', 'description': 'Percentage of infant participants reporting specific birth outcomes (normal, congenital malformation/anomaly, other neonatal problems) were reported in this outcome measure.'}, {'measure': 'Percentage of Infant Participants Reporting Adverse Events From Birth Through 1 Month of Age', 'timeFrame': 'From birth through 1 month of age', 'description': 'An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method.'}, {'measure': 'Percentage of Infant Participants Reporting Serious Adverse Events (SAE) From Birth Through 6 Months of Age', 'timeFrame': 'From birth through 6 months of age', 'description': 'An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.'}, {'measure': 'Percentage of Infant Participants Reporting Adverse Event of Special Interest (AESI) From Birth Through 6 Months of Age', 'timeFrame': 'From birth through 6 months of age', 'description': 'Percentage of infant participants who reported AESI including major congenital anomalies and developmental delay from birth through 6 months of age were reported in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method.'}, {'measure': 'GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants', 'timeFrame': 'At birth and 6 months of age', 'description': 'GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ. GMCs of full-length S-binding IgG levels at birth and 6 months of age in infant participants born to evaluable maternal participants was reported in this outcome measure.'}, {'measure': 'GMFR of Full-Length S-Binding IgG Levels From Birth to 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants', 'timeFrame': 'From birth to 6 months of age', 'description': 'GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ. GMFR of full-length S-binding IgG levels from birth to 6 months of age in infant participants born to evaluable maternal participants was reported in this outcome measure.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2 Infection', 'COVID-19', 'Maternal Immunization'], 'conditions': ['SARS-CoV-2 Infection', 'COVID-19', 'Maternal Immunization']}, 'referencesModule': {'references': [{'pmid': '35473709', 'type': 'DERIVED', 'citation': 'Nana M, Hodson K, Lucas N, Camporota L, Knight M, Nelson-Piercy C. Diagnosis and management of covid-19 in pregnancy. BMJ. 2022 Apr 26;377:e069739. doi: 10.1136/bmj-2021-069739.'}, {'pmid': '35316227', 'type': 'DERIVED', 'citation': 'Mohapatra S, Ananda P, Tripathy S. Pharmacological consideration of COVID-19 infection and vaccines in pregnancy. J Chin Med Assoc. 2022 May 1;85(5):537-542. doi: 10.1097/JCMA.0000000000000712. Epub 2022 May 2.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4591015', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "Results will be submitted, however please note that data are not yet available for all serology outcome measures.\n\nThis will be a Phase 2/3, randomized, placebo-controlled, observer-blind study evaluating the safety, tolerability, and immunogenicity of 30 µg of BNT162b2 or placebo administered in 2 doses, 21 days apart, in approximately 350 healthy pregnant women 18 years of age or older vaccinated at 24 to 34 weeks' gestation. Participants will be randomized 1:1 to receive BNT162b2 or placebo (saline).", 'detailedDescription': "The Phase 2 portion of the study will include approximately 200 pregnant women randomized 1:1 to receive BNT162b2 or placebo (saline) at 27 to 34 weeks' gestation. IRC review of safety data through 7 days after the second dose for all Phase 2 participants will be completed.\n\nThe Phase 3 portion of this study will assess the safety, tolerability, and immunogenicity of BNT162b2 among pregnant women enrolled at 24 to 34 weeks' gestation.\n\nMaternal participants who originally received placebo will receive BNT162b2 at defined time points as part of the study."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy women ≥18 years of age who are between 24 0/7 and 34 0/7 weeks' gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.\n2. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n3. Healthy participants who are determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study\n4. Documented negative HIV antibody test (Phase 2 only), syphilis test, and HBV surface antigen test during this pregnancy and prior to randomization\n5. Participant is willing to give informed consent for her infant to participate in the study\n6. Capable of giving signed informed consent\n\nExclusion Criteria:\n\n1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n2. Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.\n3. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention or any related vaccine.\n4. Participants with known or suspected immunodeficiency.\n5. Bleeding diathesis or condition associated with prolonged bleeding that would in the opinion of the investigator contraindicate intramuscular injection.\n6. Previous vaccination with any coronavirus vaccine.\n7. Receipt of medications intended to prevent COVID 19.\n8. Receipt of blood/plasma products or immunoglobulin, from 60 days before administration of study intervention, or planned receipt through delivery, with 1 exception, anti-D immunoglobulin (eg, RhoGAM), which can be given at any time.\n9. Current alcohol abuse or illicit drug use.\n10. Participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt through the postvaccination blood draw.\n11. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.\n12. Previous participation in other studies involving study intervention containing LNPs.\n13. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.\n14. Participants whose unborn baby has been fathered by investigational site staff members directly involved in the conduct of the study or their family members, site staff members otherwise supervised by the investigator, or Pfizer employees directly involved in the conduct of the study."}, 'identificationModule': {'nctId': 'NCT04754594', 'briefTitle': 'To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioNTech SE'}, 'officialTitle': 'A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE (BNT162b2) AGAINST COVID-19 IN HEALTHY PREGNANT WOMEN 18 YEARS OF AGE AND OLDER', 'orgStudyIdInfo': {'id': 'C4591015'}, 'secondaryIdInfos': [{'id': '2020-005444-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 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