Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-03-03 @ 1:12 PM
Study NCT ID:
NCT03926728
Status:
COMPLETED
Last Update Posted:
2024-08-22
First Post:
2019-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of a Chlamydia Vaccine CTH522
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014141', 'term': 'Trachoma'}, {'id': 'D002690', 'term': 'Chlamydia Infections'}], 'ancestors': [{'id': 'D003234', 'term': 'Conjunctivitis, Bacterial'}, {'id': 'D015818', 'term': 'Eye Infections, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D002694', 'term': 'Chlamydiaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PRSK@SSI.dk', 'phone': '+4532688554', 'title': 'Per Skallerup', 'organization': 'Statens Serum Institut'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Screening and recruitment activities had to be paused during the trial due to the Covid-19 pandemic.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 238 days after first vaccination', 'description': 'The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Cohort F1 IM Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Cohort F2 IM Placebo + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Deafness bilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Ear congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Erythema of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Eyelid irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 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{'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 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'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pityriasis rosea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 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'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Solicited Local Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG001', 'title': 'Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG002', 'title': 'Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG003', 'title': 'Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.'}, {'id': 'OG004', 'title': 'Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG005', 'title': 'Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG006', 'title': 'Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.'}, {'id': 'OG007', 'title': 'Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG008', 'title': 'Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140.'}, {'id': 'OG009', 'title': 'Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG010', 'title': 'Cohort F1 IM Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG011', 'title': 'Cohort F2 IM Placebo + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28 ,and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.'}], 'classes': [{'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Injection site warmth', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Injection site pruritus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'analyses': [{'pValue': '1', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007'], 'pValueComment': 'Simple nonparametric statistical test.', 'groupDescription': 'Comparison: Cohort A-C \\[A1, A2, B1, B2, C1, C2\\] vs D \\[D1, D2\\].', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '1', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG008', 'OG009'], 'pValueComment': 'Simple nonparametric statistical test.', 'groupDescription': 'Comparison: Cohort A-C \\[A1, A2, B1, B2, C1, C2\\] vs E \\[E1, E2\\].', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0007', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG010', 'OG011'], 'groupDescription': 'Comparison: Cohort A-C \\[A1, A2, B1, B2, C1, C2\\] vs F \\[F1, F2\\].', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 2 (Day 0) plus 14 Days', 'description': 'Local injection site reactions after intramuscular vaccination. Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Solicited Local Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG001', 'title': 'Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG002', 'title': 'Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG003', 'title': 'Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.'}, {'id': 'OG004', 'title': 'Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG005', 'title': 'Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG006', 'title': 'Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG007', 'title': 'Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG008', 'title': 'Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG009', 'title': 'Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG010', 'title': 'Cohort F1 IM Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG011', 'title': 'Cohort F2 IM Placebo + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.'}], 'classes': [{'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}]}]}, {'title': 'Injection site warmth', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Injection site pruritus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 4 (Day 28) plus 14 Days', 'description': 'Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentages calculated from number of participants vaccinated on Day 28.'}, {'type': 'PRIMARY', 'title': 'Solicited Local Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG001', 'title': 'Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG002', 'title': 'Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG003', 'title': 'Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.'}, {'id': 'OG004', 'title': 'Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG005', 'title': 'Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG006', 'title': 'Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG007', 'title': 'Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG008', 'title': 'Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG009', 'title': 'Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG010', 'title': 'Cohort F1 IM Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG011', 'title': 'Cohort F2 IM Placebo + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.'}], 'classes': [{'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Injection site warmth', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Injection site pruritus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 7 (Day 112) plus 14 Days', 'description': 'Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentages calculated from number of participants vaccinated on Day 112'}, {'type': 'PRIMARY', 'title': 'Solicited Local Ocular Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG001', 'title': 'Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG002', 'title': 'Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG003', 'title': 'Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.'}, {'id': 'OG004', 'title': 'Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG005', 'title': 'Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG006', 'title': 'Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG007', 'title': 'Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG008', 'title': 'Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG009', 'title': 'Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG010', 'title': 'Cohort F1 IM Placebo + TO Placebo', 'description': 'Participants received 3 IMvaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG011', 'title': 'Cohort F2 IM Placebo + ID Placebo + TO Placebo', 'description': 'Participants received 3 IMvaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.'}], 'classes': [{'title': 'Ocular discomfort', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Lacrimation increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Ocular hyperaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Swelling of eyelid', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'analyses': [{'pValue': '1', 'groupIds': ['OG001', 'OG002', 'OG003'], 'pValueComment': 'Simple nonparametric statistical test.', 'groupDescription': 'Comparison: Cohort B \\[B1, B2\\] vs A2.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.3956', 'groupIds': ['OG002', 'OG003', 'OG010'], 'groupDescription': 'Comparison: Cohort B \\[B1, B2\\] vs F1.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 4 (Day 28) plus 14 Days', 'description': 'Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentages calculated from number of participants vaccinated on Day 28'}, {'type': 'PRIMARY', 'title': 'Solicited Local Ocular Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day0, 28, and 112). In addition, participants received ID placebo given on Day 28 and112 and TO placebo given on Day 140.'}, {'id': 'OG001', 'title': 'Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day140.'}, {'id': 'OG002', 'title': 'Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day140.'}, {'id': 'OG003', 'title': 'Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.'}, {'id': 'OG004', 'title': 'Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG005', 'title': 'Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day140.'}, {'id': 'OG006', 'title': 'Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG007', 'title': 'Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG008', 'title': 'Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG009', 'title': 'Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG010', 'title': 'Cohort F1 IM Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG011', 'title': 'Cohort F2 IM Placebo + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.'}], 'classes': [{'title': 'Ocular discomfort', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Ocular hyperaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Lacrimation increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'analyses': [{'pValue': '1', 'groupIds': ['OG001', 'OG002', 'OG003'], 'pValueComment': 'Simple nonparametric statistical test.', 'groupDescription': 'Comparison: Cohort B \\[B1, B2\\] vs A2.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.3956', 'groupIds': ['OG002', 'OG003', 'OG010'], 'groupDescription': 'Comparison: Cohort B \\[B1, B2\\] vs F1.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 7 (Day 112) plus 14 Days', 'description': 'Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentages calculated from number of participants vaccinated on Day 112'}, {'type': 'PRIMARY', 'title': 'Solicited Local Ocular Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG001', 'title': 'Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG002', 'title': 'Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG003', 'title': 'Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.'}, {'id': 'OG004', 'title': 'Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG005', 'title': 'Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG006', 'title': 'Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG007', 'title': 'Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG008', 'title': 'Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG009', 'title': 'Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG010', 'title': 'Cohort F IM Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received either TO placebo or ID placebo given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG011', 'title': 'Cohort F2 IM Placebo + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.'}], 'classes': [{'title': 'Ocular discomfort', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Lacrimation increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Ocular hyperaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Swelling of eyelid', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 9 (Day 140) plus 14 Days', 'description': 'Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentages calculated from number of participants vaccinated on Day 140'}, {'type': 'PRIMARY', 'title': 'Solicited Systemic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebogiven on Day 140.'}, {'id': 'OG001', 'title': 'Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG002', 'title': 'Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG003', 'title': 'Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.'}, {'id': 'OG004', 'title': 'Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG005', 'title': 'Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG006', 'title': 'Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG007', 'title': 'Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG008', 'title': 'Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG009', 'title': 'Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG010', 'title': 'Cohort F1 IM Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG011', 'title': 'Cohort F2 IM Placebo + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.'}], 'classes': [{'title': 'Myalgia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'analyses': [{'pValue': '1', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007'], 'pValueComment': 'Simple nonparametric statistical test.', 'groupDescription': 'Comparison: Cohort A-C \\[A1, A2, B1, B2, C1, C2\\] vs D \\[D1, D2\\].', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '1', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG008', 'OG009'], 'pValueComment': 'Simple nonparametric statistical test.', 'groupDescription': 'Comparison: Cohort A-C \\[A1, A2, B1, B2, C1, C2\\] vs E \\[E1, E2\\].', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.3229', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG010', 'OG011'], 'groupDescription': 'Comparison: Cohort A-C \\[A1, A2, B1, B2, C1, C2\\] vs F \\[F1, F2\\].', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 2 (Day 0) plus 14 Days', 'description': 'Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \\> 38.3°C, chills, myalgia, and rash.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentages calculated from number of participants vaccinated on Day 0'}, {'type': 'PRIMARY', 'title': 'Solicited Systemic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG001', 'title': 'Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG002', 'title': 'Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG003', 'title': 'Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.'}, {'id': 'OG004', 'title': 'Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG005', 'title': 'Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG006', 'title': 'Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG007', 'title': 'Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG008', 'title': 'Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG009', 'title': 'Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG010', 'title': 'Cohort F1 IM Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG011', 'title': 'Cohort F2 IM Placebo + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.'}], 'classes': [{'title': 'Myalgia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 4 (Day 28) plus 14 Days', 'description': 'Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \\> 38.3°C, chills, myalgia, and rash.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentages calculated from number of participants vaccinated on Day 28'}, {'type': 'PRIMARY', 'title': 'Solicited Systemic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG001', 'title': 'Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG002', 'title': 'Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG003', 'title': 'Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.'}, {'id': 'OG004', 'title': 'Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG005', 'title': 'Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG006', 'title': 'Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG007', 'title': 'Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinationsof 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG008', 'title': 'Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebogiven on Day 28, 112, and 140.'}, {'id': 'OG009', 'title': 'Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG010', 'title': 'Cohort F1 IM Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG011', 'title': 'Cohort F2 IM Placebo + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.'}], 'classes': [{'title': 'Myalgia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'chills', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 7 (Day 112) plus 14 Days', 'description': 'Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \\> 38.3°C, chills, myalgia, and rash.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentages calculated from number of participants vaccinated on Day 112'}, {'type': 'SECONDARY', 'title': 'Immunogenicity (4-fold Increase From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG001', 'title': 'Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG002', 'title': 'Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG003', 'title': 'Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.'}, {'id': 'OG004', 'title': 'Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG005', 'title': 'Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG006', 'title': 'Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG007', 'title': 'Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG008', 'title': 'Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG009', 'title': 'Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG010', 'title': 'Cohort F1 IM Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG011', 'title': 'Cohort F2 IM Placebo + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.'}], 'classes': [{'title': 'Day 14', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Day 42', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Day 112', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Day 126', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Day 140', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Day 154', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Day 238', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14, 28, 42, 56, 112, 126, 140, 154, 238', 'description': 'Frequency of 4-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Frequency of 4-fold increase seroconversion for anti-CTH522 IgG - full analysis set'}, {'type': 'SECONDARY', 'title': 'Immunogenicity (10-fold Increase From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG001', 'title': 'Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG002', 'title': 'Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG003', 'title': 'Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.'}, {'id': 'OG004', 'title': 'Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'OG005', 'title': 'Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'OG006', 'title': 'Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG007', 'title': 'Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG008', 'title': 'Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG009', 'title': 'Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'OG010', 'title': 'Cohort F1 IM Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'OG011', 'title': 'Cohort F2 IM Placebo + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.'}], 'classes': [{'title': 'Day 14', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Day 42', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Day 112', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Day 126', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Day 140', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Day 154', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Day 238', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14, 28, 42, 56, 112, 126, 140, 154, 238', 'description': 'Frequency of 10-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'FG001', 'title': 'Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'FG002', 'title': 'Cohort B1 85 mcg IM CTH522-CAF01+ TO CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'FG003', 'title': 'Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.'}, {'id': 'FG004', 'title': 'Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'FG005', 'title': 'Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'FG006', 'title': 'Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'FG007', 'title': 'Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'FG008', 'title': 'Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'FG009', 'title': 'Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'FG010', 'title': 'Cohort F1 IM Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'FG011', 'title': 'Cohort F2 IM Placebo + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '9'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '8'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '65', 'groupId': 'BG012'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'BG001', 'title': 'Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'BG002', 'title': 'Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'BG003', 'title': 'Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140.'}, {'id': 'BG004', 'title': 'Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140.'}, {'id': 'BG005', 'title': 'Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140.'}, {'id': 'BG006', 'title': 'Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'BG007', 'title': 'Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'BG008', 'title': 'Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'BG009', 'title': 'Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522', 'description': 'Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.'}, {'id': 'BG010', 'title': 'Cohort F1 IM Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140.'}, {'id': 'BG011', 'title': 'Cohort F2 IM Placebo + ID Placebo + TO Placebo', 'description': 'Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140.'}, {'id': 'BG012', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '65', 'groupId': 'BG012'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '26.9', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '21.7', 'spread': '2.1', 'groupId': 'BG002'}, {'value': '28.4', 'spread': '7.3', 'groupId': 'BG003'}, {'value': '32.3', 'spread': '6.1', 'groupId': 'BG004'}, {'value': '22.4', 'spread': '2.4', 'groupId': 'BG005'}, {'value': '25.7', 'spread': '9', 'groupId': 'BG006'}, {'value': '26.8', 'spread': '5.6', 'groupId': 'BG007'}, {'value': '31.7', 'spread': '8.5', 'groupId': 'BG008'}, {'value': '30.1', 'spread': '9.9', 'groupId': 'BG009'}, {'value': '24.7', 'spread': '5.5', 'groupId': 'BG010'}, {'value': '25.0', 'spread': '5.3', 'groupId': 'BG011'}, {'value': '26.8', 'spread': '6.8', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '34', 'groupId': 'BG012'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '31', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '46', 'groupId': 'BG012'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '8', 'groupId': 'BG012'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '8', 'groupId': 'BG012'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '65', 'groupId': 'BG012'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '20.70', 'spread': '3.96', 'groupId': 'BG000'}, {'value': '24.78', 'spread': '3.02', 'groupId': 'BG001'}, {'value': '23.73', 'spread': '2.25', 'groupId': 'BG002'}, {'value': '22.62', 'spread': '3.58', 'groupId': 'BG003'}, {'value': '26.23', 'spread': '2.55', 'groupId': 'BG004'}, {'value': '23.63', 'spread': '2.41', 'groupId': 'BG005'}, {'value': '24.70', 'spread': '1.55', 'groupId': 'BG006'}, {'value': '23.13', 'spread': '1.67', 'groupId': 'BG007'}, {'value': '21.70', 'spread': '0.92', 'groupId': 'BG008'}, {'value': '24.11', 'spread': '3.55', 'groupId': 'BG009'}, {'value': '24.37', 'spread': '3.20', 'groupId': 'BG010'}, {'value': '22.77', 'spread': '0.55', 'groupId': 'BG011'}, {'value': '23.64', 'spread': '2.78', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-14', 'size': 3082519, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-01T04:03', 'hasProtocol': True}, {'date': '2022-01-25', 'size': 913540, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-01T04:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-25', 'studyFirstSubmitDate': '2019-04-15', 'resultsFirstSubmitDate': '2023-08-02', 'studyFirstSubmitQcDate': '2019-04-23', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-25', 'studyFirstPostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Solicited Local Injection Site Reactions', 'timeFrame': 'Visit 2 (Day 0) plus 14 Days', 'description': 'Local injection site reactions after intramuscular vaccination. Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.'}, {'measure': 'Solicited Local Injection Site Reactions', 'timeFrame': 'Visit 4 (Day 28) plus 14 Days', 'description': 'Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.'}, {'measure': 'Solicited Local Injection Site Reactions', 'timeFrame': 'Visit 7 (Day 112) plus 14 Days', 'description': 'Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.'}, {'measure': 'Solicited Local Ocular Reactions', 'timeFrame': 'Visit 4 (Day 28) plus 14 Days', 'description': 'Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.'}, {'measure': 'Solicited Local Ocular Reactions', 'timeFrame': 'Visit 7 (Day 112) plus 14 Days', 'description': 'Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.'}, {'measure': 'Solicited Local Ocular Reactions', 'timeFrame': 'Visit 9 (Day 140) plus 14 Days', 'description': 'Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.'}, {'measure': 'Solicited Systemic Reactions', 'timeFrame': 'Visit 2 (Day 0) plus 14 Days', 'description': 'Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \\> 38.3°C, chills, myalgia, and rash.'}, {'measure': 'Solicited Systemic Reactions', 'timeFrame': 'Visit 4 (Day 28) plus 14 Days', 'description': 'Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \\> 38.3°C, chills, myalgia, and rash.'}, {'measure': 'Solicited Systemic Reactions', 'timeFrame': 'Visit 7 (Day 112) plus 14 Days', 'description': 'Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \\> 38.3°C, chills, myalgia, and rash.'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity (4-fold Increase From Baseline)', 'timeFrame': 'Day 14, 28, 42, 56, 112, 126, 140, 154, 238', 'description': 'Frequency of 4-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations.'}, {'measure': 'Immunogenicity (10-fold Increase From Baseline)', 'timeFrame': 'Day 14, 28, 42, 56, 112, 126, 140, 154, 238', 'description': 'Frequency of 10-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CTH522', 'Chlamydia', 'C. Trachomatis'], 'conditions': ['Trachoma']}, 'referencesModule': {'references': [{'pmid': '38615673', 'type': 'DERIVED', 'citation': 'Pollock KM, Borges AH, Cheeseman HM, Rosenkrands I, Schmidt KL, Sondergaard RE, Day S, Evans A, McFarlane LR, Joypooranachandran J, Amini F, Skallerup P, Dohn RB, Jensen CG, Olsen AW, Bang P, Cole T, Schronce J, Lemm NM, Kristiansen MP, Andersen PL, Dietrich J, Shattock RJ, Follmann F. An investigation of trachoma vaccine regimens by the chlamydia vaccine CTH522 administered with cationic liposomes in healthy adults (CHLM-02): a phase 1, double-blind trial. Lancet Infect Dis. 2024 Aug;24(8):829-844. doi: 10.1016/S1473-3099(24)00147-6. Epub 2024 Apr 11.'}]}, 'descriptionModule': {'briefSummary': 'CHLM-02 was a phase I, double-blind, randomized, placebo-controlled trial of the chlamydia vaccine CTH522. 65 trial participants were randomized into 12 groups and six cohorts (A1 to F2). Cohorts A to E received three intramuscular (IM) injections of CTH522 (Day 0, 28, and 112). Cohorts A to D received CTH522 adjuvanted with Cationic Adjuvant Formulation (CAF®) 01 IM in two doses (85µg \\[A to C\\] or 15µg \\[D\\]). Cohort E received 85µg CTH522 adjuvanted with CAF®09b. Cohorts B and C received unadjuvanted CTH522 boost via the topic ocular (TO) or intradermal (ID) route, respectively, jointly with the second and third IM vaccinations. Cohort F received placebo. The effect of mucosal recall on eye immunity with TO CTH522 or placebo was assessed Day 140.', 'detailedDescription': 'This trial was a phase I, double-blind, parallel, randomised, and placebo-controlled trial of the chlamydia vaccine CTH522 in healthy adults.\n\nIt was planned to randomize 66 subjects but only 65 subjects were randomized. Cohorts A-D investigated CTH522-CAF01 administered IM in two doses (85 mcg and 15 mcg). Cohort E investigated CTH522-CAF09b administered IM in one dose (85 mcg). Cohort F was the placebo group. The enrolled subjects were to complete 12 trial visits. All subjects in the active cohorts (cohort A-E) were to receive three IM injections of the adjuvanted CTH522 and some (cohort B and C) were to receive the non-adjuvanted CTH522 via the TO or ID route (given at the same time as the 2nd and 3rd IM vaccinations). All active cohorts were to receive TO administration as a boost at Day 140 of either the non-adjuvanted CTH522 (12 mcg in each eye) or placebo.\n\n* Cohort A received three IM vaccination of 85 mcg CTH522-CAF01. This cohort was divided into two groups: A1 received ID placebo at Day 28 and Day 112, and TO placebo at Day 140, while A2 received TO placebo at Day 28 and Day 112, and non-adjuvanted TO CTH522 boost at Day 140.\n* Cohort B received three IM vaccinations of 85 mcg CTH522-CAF01. This cohort was divided into two groups: B1 received TO vaccination of the non-adjuvanted CTH522 at Day 28 and 112 and TO placebo at Day 140, while B2 received the same for Day 28 and 112, but non-adjuvanted TO CTH522 boost at Day 140. The two additional TO doses of CTH522 (12 mcg in each eye) were administered in each eye. The rationale for this schedule was to investigate the impact of simultaneous TO administration of the antigen on the immunogenicity results.\n* Cohort C received three IM vaccinations of 85 mcg CTH522-CAF01. This cohort was divided into two groups: C1 received ID vaccination of the non-adjuvanted 24 mcg CTH522 at Day 28 and 112 and TO placebo at Day 140, while C2 received the same for Day 28 and 112, but TO 12 mcg CTH522 boost in each eye at Day 140. The rationale for this schedule was to investigate the impact of simultaneous ID administration of the antigen on the immunogenicity results.\n* Cohort D received three IM vaccinations of 15 mcg CTH522-CAF01. The rationale for the A and D cohorts was to investigate the impact of the two IM CTH522 doses on the immunogenicity results.\n* Cohort E received three IM vaccinations of 85 mcg CTH522-CAF09b. The rationale for the A and E cohorts was to investigate the impact of the adjuvant on the immunogenicity results.\n* Cohort F received placebo in the form of 0.9% NaCl saline (IM, ID and TO).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nIC1: Healthy males and females between 18-45 years old on the day of the first vaccination.\n\nIC2: Has been properly informed about the trial and signed the consent form.\n\nIC3: Is willing and likely to comply with trial procedures.\n\nIC4: Is prepared to grant authorised persons access to his/her trial-related medical record.\n\nIC5: Is willing to use acceptable contraceptive measures during the trial (two weeks before and two weeks after the trial). Heterosexually active female capable of becoming pregnant must agree to use hormonal contraception, intrauterine device, intrauterine hormone releasing system, or to complete abstinence from at least two weeks before the first vaccination until at least two weeks after the last. Complete abstinence (defined as refraining from heterosexual intercourse) must be in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods), withdrawal and progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, are not acceptable methods of contraception.\n\nExclusion criteria:\n\nEX1: Is positive for C. trachomatis via urine PCR or has a known history of C. trachomatis.\n\nEX2: Is positive for gonorrhoea via urine PCR test, or HIV, hepatitis B/C, syphilis via blood tests.\n\nEX3: Has a significant active disease such as cardiac, liver, immunological, neurological, psychiatric, or clinically significant abnormality of haematological or biochemical parameters.\n\nEX4: Has BMI ≥ 35 kg/m2.\n\nEX5: Is currently participating in another clinical trial with an investigational or noninvestigational drug or device, or was treated with an investigational drug within 28 days before the first vaccination.\n\nEX6: Has received, or plans to receive, any immunisation within 14 days of the start of the trial or during the trial immunisations.\n\nEX7: Is currently receiving treatment with systemic immunosuppressive agents. Topical steroids are allowed unless applied to the IM or ID injection site.\n\nEX8: Has a condition which in the opinion of the investigator is not suitable for participation in the trial.\n\nEX9: Is known or confirmed to have an allergy to any of the vaccine constituents.\n\nEX10: Is unable to refrain from the use of contact lenses. Contact lenses should be avoided two days before TO administration and for seven days later (longer if any ongoing local eye AE).\n\nEX11: Has any evident ocular disease upon ophthalmoscopic exam at screening or any medical history of ocular disease that, in the opinion of the investigator, may impact the subject's participation in the trial.\n\nEX12: Is pregnant (positive pregnancy test) or breastfeeding or not willing to use contraception during the trial.\n\nEX13: Has confirmed a history of pelvic inflammatory disease or significant gynaecological diseases."}, 'identificationModule': {'nctId': 'NCT03926728', 'acronym': 'CHLM-02', 'briefTitle': 'Safety and Immunogenicity of a Chlamydia Vaccine CTH522', 'organization': {'class': 'OTHER', 'fullName': 'Statens Serum Institut'}, 'officialTitle': 'A Phase I, Double-blind, Parallel, Randomised and Placebo-controlled Trial Investigating the Safety and Immunogenicity of a Chlamydia Vaccine, CTH522, in Healthy Adults', 'orgStudyIdInfo': {'id': 'CHLM-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A 85 mcg CTH522-CAF01', 'description': 'Cohort A received three IM vaccination of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). This cohort was divided into two groups: Cohort A1 receives placebo at Day 28, 112, and 140, while cohort A2 received placebo at Day 28 and 112, but non-adjuvanted TO CTH522 boost at Day 140.', 'interventionNames': ['Biological: CTH522-CAF01 IM', 'Biological: CTH522 TO', 'Biological: Placebo (Saline)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B 85 mcg CTH522-CAF01 + TO CTH522', 'description': 'Cohort B received three IM vaccination of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). This cohort was divided into two groups: Cohort B1 received TO vaccination of the non-adjuvanted CTH522 at Day 28 and 112 and TO placebo at Day 140, while cohort B2 received the same for Day 28 and 112, but non-adjuvanted TO CTH522 boost at Day 140.', 'interventionNames': ['Biological: CTH522-CAF01 IM', 'Biological: CTH522 TO', 'Biological: Placebo (Saline)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C 85 mcg CTH522-CAF01 + ID CTH522', 'description': 'Cohort C received three IM vaccination of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). This cohort was divided into two groups: Cohort C1 received ID vaccination of the non-adjuvanted CTH522 at Day 28 and 112 and TO placebo at Day 140, while cohort C2 received the same for Day 28 and 112, but TO CTH522 boost at Day 140.', 'interventionNames': ['Biological: CTH522-CAF01 IM', 'Biological: CTH522 ID', 'Biological: CTH522 TO', 'Biological: Placebo (Saline)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort D 15 mcg CTH522-CAF01', 'description': 'Cohort D received three IM vaccination of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). This cohort was divided into two groups: Cohort D1 received TO placebo given on Day 28, 112, and 140, while cohort D2 received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.', 'interventionNames': ['Biological: CTH522-CAF01 IM', 'Biological: CTH522 TO', 'Biological: Placebo (Saline)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort E 85 mcg CTH522-CAF09b', 'description': 'Cohort E received three IM vaccination of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). This cohort was divided into two groups: Cohort E1 received TO placebo given on Day 28, 112, and 140, while cohort E2 received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.', 'interventionNames': ['Biological: CTH522-CAF09b IM', 'Biological: CTH522 TO', 'Biological: Placebo (Saline)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort F Placebo', 'description': 'Cohort F received three IM vaccinations of placebo in form of 0.9% NaCl saline (Day 0, 28, and 112).This cohort was divided into two groups: Cohort F1 received TO placebo given on Day 28, 112, and 140, while cohort F2 received ID placebo given on Day 28 and 112 and TO placebo on Day 140.', 'interventionNames': ['Biological: Placebo (Saline)']}], 'interventions': [{'name': 'CTH522-CAF01 IM', 'type': 'BIOLOGICAL', 'description': 'On-site reconstitution of IMPs is performed by mixing 85 mcg CTH522 with CAF01. The preferred for IM is in the non-dominant deltoid muscle. IM injection will be performed with a 1-2 mL polypropylene Luer-Lok™ syringe via 23-25 gauge needle. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.', 'armGroupLabels': ['Cohort A 85 mcg CTH522-CAF01', 'Cohort B 85 mcg CTH522-CAF01 + TO CTH522', 'Cohort C 85 mcg CTH522-CAF01 + ID CTH522', 'Cohort D 15 mcg CTH522-CAF01']}, {'name': 'CTH522-CAF09b IM', 'type': 'BIOLOGICAL', 'description': 'On-site reconstitution of IMPs is performed by mixing 85 mcg CTH522 with CAF09b. The preferred for IM is in the non-dominant deltoid muscle. IM injection will be performed with a 1-2 mL polypropylene Luer-Lok™ syringe via 23-25 gauge needle. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.', 'armGroupLabels': ['Cohort E 85 mcg CTH522-CAF09b']}, {'name': 'CTH522 ID', 'type': 'BIOLOGICAL', 'description': '24 mcg CTH522 given ID is in the non-dominant deltoid muscle. ID with a 1 mL syringe via a 26-28 gauge needle using a NanoPass device or similar. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.', 'armGroupLabels': ['Cohort C 85 mcg CTH522-CAF01 + ID CTH522']}, {'name': 'CTH522 TO', 'type': 'BIOLOGICAL', 'description': '24 mcg CTH522 (12 mcg in each eye) TO administrations will be performed using a Gilson positive displacement pipette. The identity of vaccine will be known to the clinical site staff dispensing/administrating the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.', 'armGroupLabels': ['Cohort A 85 mcg CTH522-CAF01', 'Cohort B 85 mcg CTH522-CAF01 + TO CTH522', 'Cohort C 85 mcg CTH522-CAF01 + ID CTH522', 'Cohort D 15 mcg CTH522-CAF01', 'Cohort E 85 mcg CTH522-CAF09b']}, {'name': 'Placebo (Saline)', 'type': 'BIOLOGICAL', 'description': 'Placebo only given as IM, ID and TO.', 'armGroupLabels': ['Cohort A 85 mcg CTH522-CAF01', 'Cohort B 85 mcg CTH522-CAF01 + TO CTH522', 'Cohort C 85 mcg CTH522-CAF01 + ID CTH522', 'Cohort D 15 mcg CTH522-CAF01', 'Cohort E 85 mcg CTH522-CAF09b', 'Cohort F Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W12', 'city': 'London', 'country': 'United Kingdom', 'facility': 'NIHR Imperial Center for Translational and Experimental Medicine', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Alvaro Borges, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Statens Serum Institut'}, {'name': 'Katrina Pollock, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial Clinical Research Facility Hammersmith Hospital'}, {'name': 'Lina S Stoey, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Statens Serum Institut'}, {'name': 'Pernille N Tingskov, BS', 'role': 'STUDY_CHAIR', 'affiliation': 'Statens Serum Institut'}, {'name': 'Rebecca B Dohn, Pharm', 'role': 'STUDY_CHAIR', 'affiliation': 'Statens Serum Institut'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Statens Serum Institut', 'class': 'OTHER'}, 'collaborators': [{'name': 'Imperial College London', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}