Viewing Study NCT01978093

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Ignite Creation Date: 2025-12-25 @ 12:58 AM
Ignite Modification Date: 2026-03-02 @ 7:44 AM
Study NCT ID: NCT01978093
Status: COMPLETED
Last Update Posted: 2018-09-14
First Post: 2013-10-31
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006192', 'term': 'Haemophilus Infections'}], 'ancestors': [{'id': 'D016871', 'term': 'Pasteurellaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C527605', 'term': 'Hib-MenCY-TT vaccine'}, {'id': 'C472675', 'term': 'PEDIARIX'}, {'id': 'C492457', 'term': 'RIX4414 vaccine'}, {'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}, {'id': 'C061964', 'term': 'Haemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine'}, {'id': 'D022362', 'term': 'Hepatitis A Vaccines'}], 'ancestors': [{'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)', 'eventGroups': [{'id': 'EG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.', 'otherNumAtRisk': 297, 'deathsNumAtRisk': 297, 'otherNumAffected': 282, 'seriousNumAtRisk': 297, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.', 'otherNumAtRisk': 303, 'deathsNumAtRisk': 303, 'otherNumAffected': 291, 'seriousNumAtRisk': 303, 'deathsNumAffected': 0, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal faeces', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Accidental exposure to product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Administration site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Administration site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aerophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankyloglossia congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Body height below normal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Body tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Burns second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cafe au lait spots', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Candida nappy rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac murmur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Communication disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congenital torticollis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 32, 'numAffected': 31}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coxsackie viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Craniosynostosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dacryocystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dacryostenosis acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dacryostenosis congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 331, 'numAffected': 177}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 384, 'numAffected': 200}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Developmental hip dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 31, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema infectiosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exanthema subitum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeding disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fontanelle depressed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foreign body in gastrointestinal tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Frenulum breve', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 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'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting projectile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight gain poor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Histiocytosis haematophagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sudden infant death syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Apparent life threatening event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Kawasaki's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 1.0 µg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '99.5'}, {'value': '97.2', 'groupId': 'OG001', 'lowerLimit': '94.1', 'upperLimit': '99.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '-2.12', 'ciUpperLimit': '4.30', 'groupDescription': 'Difference between HibCY and PedHIB groups in percentage of subjects with anti-PRP concentrations equal to or above the cut-off value of 1.0 µg/mL one month after the fourth dose in HibCY Group and third dose in PedHIB Group.', 'statisticalMethod': 'Group difference in proportions', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Before concluding on the primary objectives for Rotarix, Prevnar 13 and Havrix, this primary objective regarding anti-PRP needs to be reached', 'nonInferiorityComment': 'Lower limit of the standardized asymptotic 95% CI for the difference (HibCY group minus the PedHIB group) in the percentage of subjects with anti-PRP concentrations ≥1.0 mg/mL is to be≥-10% (clinical limit for non-inferiority).'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the fourth dose for HibCY Group and 1 month after third dose for PedHIB Group [Month (M) 11-14]', 'description': 'Percentage of subjects with Anti-PRP antibody concentrations≥1.0 µg/mL were assessed.\n\nAnalysis of Immunogenicity is performed on blood sample (BS) sub-cohorts. Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Fourth dose According to Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who have received 3 vaccine doses in the first 3-doses vaccination course and who have received the fourth vaccine dose and the first Havrix dose.'}, {'type': 'PRIMARY', 'title': 'Anti-rotavirus Serum Immunoglobulin A (IgA) Geometric Mean Concentrations (GMCs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'categories': [{'measurements': [{'value': '138.9', 'groupId': 'OG000', 'lowerLimit': '104.0', 'upperLimit': '185.5'}, {'value': '115.0', 'groupId': 'OG001', 'lowerLimit': '87.5', 'upperLimit': '151.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratios', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.21', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.90', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001(Rotarix \\& Prevnar13 Post dose 3)\\& Epoch 002 (Havrix \\& Prevnar13 post dose 4),a Bonferroni correction is used in order to test these objectives(1.25% 1sided for Epoch 001 \\& 002)', 'groupDescription': 'GMC ratios between HibCY and PedHIB groups for anti-Rota IgA concentrations 2 months after the second dose of Rotarix vaccine', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS sub-cohorts;97.5% confidence interval calculated for adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)', 'nonInferiorityComment': 'Non-inferiority is concluded if lower limit of the two-sided standardized asymptotic 97.5% CI on the ratio of anti-rotavirus IgA GMC (HibCY group over PedHIB group) is to be ≥0.5'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2 months post-dose 2 of Rotarix (Month 4)', 'description': 'Anti-rotavirus serum IgA was assessed by ELISA, tabulated as GMCs and expressed in Units per mililiter (U/mL).Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.\n\nAssignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per a hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch', 'unitOfMeasure': 'U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Rota ATP cohort for analysis of immunogenicity, which included all evaluable subjects who received the two doses of Rotarix vaccine and for whom immunogenicity results were available.'}, {'type': 'PRIMARY', 'title': 'Anti-Streptococcus (S) Pneumoniae GMCs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'title': 'Anti-1 antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.49', 'groupId': 'OG000', 'lowerLimit': '1.30', 'upperLimit': '1.70'}, {'value': '1.26', 'groupId': 'OG001', 'lowerLimit': '1.10', 'upperLimit': '1.44'}]}]}, {'title': 'Anti-3 antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000', 'lowerLimit': '0.48', 'upperLimit': '0.63'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '0.55'}]}]}, {'title': 'Anti-4 antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '0.72', 'upperLimit': '0.90'}, {'value': '0.74', 'groupId': 'OG001', 'lowerLimit': '0.66', 'upperLimit': '0.84'}]}]}, {'title': 'Anti-5 antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.80', 'groupId': 'OG000', 'lowerLimit': '0.71', 'upperLimit': '0.91'}, {'value': '0.68', 'groupId': 'OG001', 'lowerLimit': '0.59', 'upperLimit': '0.78'}]}]}, {'title': 'Anti-6A antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.76', 'groupId': 'OG000', 'lowerLimit': '1.55', 'upperLimit': '2.00'}, {'value': '1.37', 'groupId': 'OG001', 'lowerLimit': '1.18', 'upperLimit': '1.60'}]}]}, {'title': 'Anti-6B antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '1.18'}, {'value': '0.87', 'groupId': 'OG001', 'lowerLimit': '0.73', 'upperLimit': '1.05'}]}]}, {'title': 'Anti-7F antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.59', 'groupId': 'OG000', 'lowerLimit': '2.29', 'upperLimit': '2.93'}, {'value': '2.36', 'groupId': 'OG001', 'lowerLimit': '2.10', 'upperLimit': '2.65'}]}]}, {'title': 'Anti-9V antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '0.89'}, {'value': '0.63', 'groupId': 'OG001', 'lowerLimit': '0.55', 'upperLimit': '0.73'}]}]}, {'title': 'Anti-14 antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.77', 'groupId': 'OG000', 'lowerLimit': '4.13', 'upperLimit': '5.52'}, {'value': '4.16', 'groupId': 'OG001', 'lowerLimit': '3.50', 'upperLimit': '4.94'}]}]}, {'title': 'Anti-18C antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '1.03'}, {'value': '0.74', 'groupId': 'OG001', 'lowerLimit': '0.65', 'upperLimit': '0.84'}]}]}, {'title': 'Anti-19A antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.31', 'groupId': 'OG000', 'lowerLimit': '1.17', 'upperLimit': '1.48'}, {'value': '1.13', 'groupId': 'OG001', 'lowerLimit': '0.98', 'upperLimit': '1.31'}]}]}, {'title': 'Anti-19F antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.25', 'groupId': 'OG000', 'lowerLimit': '2.02', 'upperLimit': '2.50'}, {'value': '2.10', 'groupId': 'OG001', 'lowerLimit': '1.87', 'upperLimit': '2.37'}]}]}, {'title': 'Anti-23F antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '1.10'}, {'value': '0.80', 'groupId': 'OG001', 'lowerLimit': '0.67', 'upperLimit': '0.94'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.18', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.47', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001(Rotarix \\& Prevnar13 post dose 3)\\& Epoch 002(Havrix \\& Prevnar13 post dose 4),Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \\& Epoch 002)', 'groupDescription': 'GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 1 concentrations one month after the third dose.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio (Ancova Model: adjustment for BS sub cohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 1 is to be ≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.15', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.42', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001(Rotarix \\& Prevnar13 post dose 3)\\& Epoch 002(Havrix\\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \\& Epoch 002)', 'groupDescription': 'GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 3 concentrations one month after the third dose.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 3 is to be≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.08', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.31', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001(Rotarix \\& Prevnar13 post dose 3)\\& Epoch 002(Havrix\\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \\& Epoch 002)', 'groupDescription': 'GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 4 concentrations one month after the third dose.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 4 is to be≥ 0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.18', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.47', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001(Rotarix \\& Prevnar13 post dose 3)\\& Epoch 002(Havrix\\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \\& Epoch 002)', 'groupDescription': 'GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 5 concentrations one month after the third dose.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 5 is to be ≥ 0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.29', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.63', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001(Rotarix \\& Prevnar13 post dose 3)\\& Epoch 002(Havrix\\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \\& Epoch 002)', 'groupDescription': 'GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6A concentrations one month after the third dose.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6A is to be ≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.17', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.55', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001(Rotarix \\& Prevnar13 post dose 3)\\& Epoch 002(Havrix\\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \\& Epoch 002)', 'groupDescription': 'GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6B concentrations one month after the third dose.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6B is to be≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.11', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.34', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001(Rotarix \\& Prevnar13 post dose 3)\\& Epoch 002(Havrix\\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \\& Epoch 002)', 'groupDescription': 'GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 7F concentrations one month after the third dose.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 7F is to be≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.25', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.55', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001(Rotarix \\& Prevnar13 post dose 3)\\& Epoch 002(Havrix\\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \\& Epoch 002)', 'groupDescription': 'GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 9V concentrations one month after the third dose.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 9V is to be≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.16', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.50', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001(Rotarix \\& Prevnar13 post dose 3)\\& Epoch 002(Havrix\\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \\& Epoch 002)', 'groupDescription': 'GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 14 concentrations one month after the third dose.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 14 is to be≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.24', 'ciLowerLimit': '1.01', 'ciUpperLimit': '1.52', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001(Rotarix \\& Prevnar13 post dose 3)\\& Epoch 002(Havrix\\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \\& Epoch 002)', 'groupDescription': 'GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 18C concentrations one month after the third dose.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 18C is to be ≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.16', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.43', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001(Rotarix \\& Prevnar13 post dose 3)\\& Epoch 002(Havrix\\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \\& Epoch 002)', 'groupDescription': 'GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19A concentrations one month after the third dose.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19A is to be≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.07', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.29', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001(Rotarix \\& Prevnar13 post dose 3)\\& Epoch 002(Havrix\\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \\& Epoch 002)', 'groupDescription': 'GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19F concentrations one month after the third dose.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19F is to be≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.18', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.53', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001(Rotarix \\& Prevnar13 post dose 3)\\& Epoch 002(Havrix\\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \\& Epoch 002)', 'groupDescription': 'GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 23F concentrations one month after the third dose.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 23F is to be≥0.5 (clinical limit for non-inferiority).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post-dose 3 of Prevnar 13 (Month 5)', 'description': 'Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL.\n\nAnalysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity, which included all evaluable subjects who have received three doses of Prevnar 13 vaccine and for whom immunogenicity results were available.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Anti-Hepatitis A (Anti-Havrix) Antibody Concentrations ≥ 15mIU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.1', 'upperLimit': '100'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.00', 'ciLowerLimit': '-3.76', 'ciUpperLimit': '3.91', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001(Rotarix \\& Prevnar13 post dose 3)\\& Epoch 002(Havrix \\& Prevnar13 post dose 4),Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \\& Epoch 002)', 'groupDescription': 'Difference between HibCY and PedHIB groups in percentage of subjects with anti-HAV concentrations equal to or above the cut-off value of 15 mIU/mL one month after the second Havrix dose.', 'statisticalMethod': 'Group difference in proportions', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower limit of the two-sided standardized asymptotic 97.5% CI on the difference (HibCY group minus the PedHIB group) in the percentage of subjects with anti-HAV concentrations ≥15 mIU/mL is to be≥-10% (clinical limit for non-inferiority).'}], 'paramType': 'NUMBER', 'timeFrame': '1 month post-dose 2 of Havrix (Month 17-20)', 'description': 'Percentage of subjects with Anti-Havrix (Anti-HAV) antibody concentrations was assessed. The cut-off value is ≥15 mIU/mL.\n\nAnalysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Havrix ATP cohort for analysis of immunogenicity which include all evaluable subjects who received two doses of Havrix vaccine and for whom immunogenicity results were available.'}, {'type': 'PRIMARY', 'title': 'Anti-S. Pneumoniae GMCs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'title': 'Anti-1 antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.78', 'upperLimit': '2.25'}, {'value': '1.60', 'groupId': 'OG001', 'lowerLimit': '1.43', 'upperLimit': '1.79'}]}]}, {'title': 'Anti-3 antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000', 'lowerLimit': '0.46', 'upperLimit': '0.58'}, {'value': '0.51', 'groupId': 'OG001', 'lowerLimit': '0.44', 'upperLimit': '0.59'}]}]}, {'title': 'Anti-4 antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.36', 'groupId': 'OG000', 'lowerLimit': '1.23', 'upperLimit': '1.50'}, {'value': '1.24', 'groupId': 'OG001', 'lowerLimit': '1.10', 'upperLimit': '1.39'}]}]}, {'title': 'Anti-5 antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.36', 'groupId': 'OG000', 'lowerLimit': '2.10', 'upperLimit': '2.64'}, {'value': '2.23', 'groupId': 'OG001', 'lowerLimit': '1.97', 'upperLimit': '2.52'}]}]}, {'title': 'Anti-6A antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.80', 'groupId': 'OG000', 'lowerLimit': '6.10', 'upperLimit': '7.57'}, {'value': '5.63', 'groupId': 'OG001', 'lowerLimit': '5.05', 'upperLimit': '6.26'}]}]}, {'title': 'Anti-6B antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.57', 'groupId': 'OG000', 'lowerLimit': '4.97', 'upperLimit': '6.24'}, {'value': '4.94', 'groupId': 'OG001', 'lowerLimit': '4.40', 'upperLimit': '5.55'}]}]}, {'title': 'Anti-7F antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.16', 'groupId': 'OG000', 'lowerLimit': '3.76', 'upperLimit': '4.61'}, {'value': '3.81', 'groupId': 'OG001', 'lowerLimit': '3.45', 'upperLimit': '4.21'}]}]}, {'title': 'Anti-9V antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.38', 'groupId': 'OG000', 'lowerLimit': '1.25', 'upperLimit': '1.53'}, {'value': '1.24', 'groupId': 'OG001', 'lowerLimit': '1.11', 'upperLimit': '1.39'}]}]}, {'title': 'Anti-14 antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.14', 'groupId': 'OG000', 'lowerLimit': '6.32', 'upperLimit': '8.07'}, {'value': '6.13', 'groupId': 'OG001', 'lowerLimit': '5.48', 'upperLimit': '6.86'}]}]}, {'title': 'Anti-18C antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.62', 'groupId': 'OG000', 'lowerLimit': '1.46', 'upperLimit': '1.80'}, {'value': '1.42', 'groupId': 'OG001', 'lowerLimit': '1.28', 'upperLimit': '1.57'}]}]}, {'title': 'Anti-19A antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.47', 'groupId': 'OG000', 'lowerLimit': '4.87', 'upperLimit': '6.14'}, {'value': '5.03', 'groupId': 'OG001', 'lowerLimit': '4.47', 'upperLimit': '5.64'}]}]}, {'title': 'Anti-19F antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.23', 'groupId': 'OG000', 'lowerLimit': '5.61', 'upperLimit': '6.92'}, {'value': '5.54', 'groupId': 'OG001', 'lowerLimit': '4.97', 'upperLimit': '6.18'}]}]}, {'title': 'Anti-23F antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.28', 'groupId': 'OG000', 'lowerLimit': '2.90', 'upperLimit': '3.71'}, {'value': '2.68', 'groupId': 'OG001', 'lowerLimit': '2.37', 'upperLimit': '3.05'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.25', 'ciLowerLimit': '1.04', 'ciUpperLimit': '1.51', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001 \\& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)', 'groupDescription': 'GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 1 concentrations one month after the fourth dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 1 is to be≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.01', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.24', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001 \\& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)', 'groupDescription': 'GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 3 concentrations one month after the fourth dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 3 is to be ≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.10', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.31', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001 \\& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)', 'groupDescription': 'GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 4 concentrations one month after the fourth dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 4 is to be≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.06', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.28', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001 \\& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)', 'groupDescription': 'GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 5 concentrations one month after the fourth dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 5 is to be ≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.21', 'ciLowerLimit': '1.01', 'ciUpperLimit': '1.44', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001 \\& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)', 'groupDescription': 'GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6A concentrations one month after the fourth dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6A is to be≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.13', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.36', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001 \\& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)', 'groupDescription': 'GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6B concentrations one month after the fourth dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6B is to be≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.09', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.29', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001 \\& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)', 'groupDescription': 'GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 7F concentrations one month after the fourth dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 7F is to be ≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.12', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.33', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001 \\& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)', 'groupDescription': 'GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 9V concentrations one month after the fourth dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 9V is to be ≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.16', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.41', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001 \\& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)', 'groupDescription': 'GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 14 concentrations one month after the fourth dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 14 is to be≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.14', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.35', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001 \\& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)', 'groupDescription': 'GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 18C concentrations one month after the fourth dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 18C is to be ≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.09', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.31', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001 \\& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)', 'groupDescription': 'GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19A concentrations one month after the fourth dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19A is to be ≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.12', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.34', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001 \\& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)', 'groupDescription': 'GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19F concentrations one month after the fourth dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB Group) for antibodies to S. pneumoniae serotype 19F is to be≥0.5 (clinical limit for non-inferiority).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.22', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.50', 'estimateComment': 'To be able to conclude independently on primary objectives of Epoch 001 \\& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)', 'groupDescription': 'GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 23F concentrations one month after the fourth dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)', 'nonInferiorityComment': 'Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 23F is to be≥0.5 (clinical limit for non-inferiority).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post-dose 4 of Prevnar 13 (Month 11-14)', 'description': 'Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL.\n\nAnalysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Forth dose ATP cohort for analysis of immunogenicity, which included all evaluable subjects who have received four doses of Prevnar 13 vaccine and for whom immunogenicity results were available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Anti-PRP Antibody Concentrations ≥0.15 µg/mL.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '99.9'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.7', 'upperLimit': '100'}]}]}, {'title': 'Month 11-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98.3', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Months 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)]', 'description': 'The cut-off value for this assay was 0.15 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 4 and Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months 11-14) which included all evaluable subjects for whom immunogenicity results were available.'}, {'type': 'SECONDARY', 'title': 'Anti-PRP GMCs≥ 0.15 µg/mL.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.053', 'groupId': 'OG001', 'lowerLimit': '8.740', 'upperLimit': '13.979'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.414', 'groupId': 'OG000', 'lowerLimit': '7.070', 'upperLimit': '10.014'}]}]}, {'title': 'Month 11-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.090', 'groupId': 'OG000', 'lowerLimit': '24.012', 'upperLimit': '32.862'}, {'value': '20.869', 'groupId': 'OG001', 'lowerLimit': '17.799', 'upperLimit': '24.468'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Month 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)]', 'description': 'Anti-PRP antibody concentrations were assessed by Enzyme-Linked-Immunosorbent-Assay (ELISA), tabulated as Geometric Mean Concentrations (GMCs) and expressed in micrograms per mililiter (µg/mL).The cut-off value for this assay was 0.15 µg/mL.\n\nAnalysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 4 and Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months 11-14) which included all evaluable subjects for whom immunogenicity results were available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Anti-PRP Antibody Concentrations ≥1.0 µg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB® vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG001', 'lowerLimit': '86.2', 'upperLimit': '95.3'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.0', 'groupId': 'OG000', 'lowerLimit': '89.3', 'upperLimit': '97.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 months post-dose 2 [PedHib group only (Month 4)] and 1 month postdose 3 [HibCY group only (Month 5)].', 'description': 'The cut-off value for this assay was 1.0 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 4 and Month 5) which included all evaluable subjects for whom immunogenicity results were available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'title': 'hSBA-MenC, Month 5, ≥ 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '100'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '5.0'}]}]}, {'title': 'hSBA-MenC, Month 5, ≥ 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '100'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '5.0'}]}]}, {'title': 'hSBA-MenC, Month 5, ≥ 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '96.2', 'upperLimit': '100'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.9'}]}]}, {'title': 'hSBA-MenY, Month 5, ≥ 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '93.4', 'upperLimit': '99.5'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '100'}]}]}, {'title': 'hSBA-MenY, Month 5, ≥ 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '93.4', 'upperLimit': '99.5'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '100'}]}]}, {'title': 'hSBA-MenY, Month 5, ≥ 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '93.4', 'upperLimit': '99.5'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '100'}]}]}, {'title': 'hSBA-MenC, Month 11-14, ≥ 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000', 'lowerLimit': '96.7', 'upperLimit': '99.9'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.3'}]}]}, {'title': 'hSBA-MenC, Month 11-14, ≥ 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '96.0', 'upperLimit': '99.7'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.3'}]}]}, {'title': 'hSBA-MenC, Month 11-14, ≥ 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '95.3', 'upperLimit': '99.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}, {'title': 'hSBA-MenY, Month 11-14, ≥ 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '95.6', 'upperLimit': '99.7'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98.0', 'upperLimit': '100'}]}]}, {'title': 'hSBA-MenY, Month 11-14, ≥ 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '95.6', 'upperLimit': '99.7'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98.0', 'upperLimit': '100'}]}]}, {'title': 'hSBA-MenY, Month 11-14, ≥ 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '95.6', 'upperLimit': '99.7'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98.0', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14).', 'description': 'The cut off values are dilutions of 1:8, 1:16 and 1:32. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months11-14) which included all evaluable subjects for whom immunogenicity results were available.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'title': 'hSBA-MenC, Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '807.3', 'groupId': 'OG000', 'lowerLimit': '659.2', 'upperLimit': '988.6'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '2.3'}]}]}, {'title': 'hSBA-MenY, Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '510.9', 'groupId': 'OG000', 'lowerLimit': '405.7', 'upperLimit': '643.3'}, {'value': '550.2', 'groupId': 'OG001', 'lowerLimit': '474.4', 'upperLimit': '638.1'}]}]}, {'title': 'hSBA-MenC, Month 11-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2566.2', 'groupId': 'OG000', 'lowerLimit': '2046.3', 'upperLimit': '3218.1'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '2.1'}]}]}, {'title': 'hSBA-MenY, Month 11-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2761.4', 'groupId': 'OG000', 'lowerLimit': '2274.2', 'upperLimit': '3353.1'}, {'value': '2728.2', 'groupId': 'OG001', 'lowerLimit': '2412.7', 'upperLimit': '3085.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14).', 'description': 'The cut-off values are dilutions of 1:8, 1:16 and 1:32. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.', 'unitOfMeasure': 'Titres', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months11-14) which included all evaluable subjects for whom immunogenicity results were available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Anti-rotavirus IgA Antibody Concentrations ≥ 20 Units (U)/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000', 'lowerLimit': '74.2', 'upperLimit': '87.1'}, {'value': '80.1', 'groupId': 'OG001', 'lowerLimit': '73.1', 'upperLimit': '86.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 month post-dose 2 of Rotarix (Month 4)', 'description': 'The cut-off value is 20 Units (U)/mL Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Rota ATP cohort for analysis of immunogenicity which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Anti-HAV Antibodies ≥ 15 mIU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.2', 'groupId': 'OG000', 'lowerLimit': '79.2', 'upperLimit': '90.0'}, {'value': '89.3', 'groupId': 'OG001', 'lowerLimit': '83.6', 'upperLimit': '93.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month post-dose 1 of Havrix (Month 11-14)', 'description': 'The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Fourth dose ATP cohort for analysis of immunogenicity, which included all vaccinated subjects for whom data are available.'}, {'type': 'SECONDARY', 'title': 'Anti-HAV GMCs ≥ 15 mIU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.8', 'groupId': 'OG000', 'lowerLimit': '38.3', 'upperLimit': '52.5'}, {'value': '47.3', 'groupId': 'OG001', 'lowerLimit': '40.9', 'upperLimit': '54.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post-dose 1 of HAV (M11-14).', 'description': 'The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Fourth dose ATP cohort for analysis of immunogenicity, which included all vaccinated subjects for whom data are available.'}, {'type': 'SECONDARY', 'title': 'GMCs for Anti-HAV Antibodies ≥15mIU/mL.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'categories': [{'measurements': [{'value': '1590.7', 'groupId': 'OG000', 'lowerLimit': '1312.7', 'upperLimit': '1927.5'}, {'value': '1390.6', 'groupId': 'OG001', 'lowerLimit': '1147.8', 'upperLimit': '1684.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post-dose 2 of HAV (Month 17-20).', 'description': 'The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on Havrix ATP cohort for analysis of immunogenicity which included all evaluable subjects who have received the first and second dose of Havrix and for whom assay results were available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'title': 'Anti-1 antibody, Month 5, ≥ 0.15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100'}]}]}, {'title': 'Anti-1 antibody, Month 5, ≥ 0.26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '94.5', 'upperLimit': '99.6'}, {'value': '98.7', 'groupId': 'OG001', 'lowerLimit': '95.5', 'upperLimit': '99.8'}]}]}, {'title': 'Anti-1 antibody, Month 5, ≥ 0.35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '92.7', 'upperLimit': '99.0'}, {'value': '93.7', 'groupId': 'OG001', 'lowerLimit': '88.7', 'upperLimit': '96.9'}]}]}, {'title': 'Anti-3 antibody, Month 5, ≥ 0.15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG000', 'lowerLimit': '92.3', 'upperLimit': '98.9'}, {'value': '94.0', 'groupId': 'OG001', 'lowerLimit': '88.9', 'upperLimit': '97.2'}]}]}, {'title': 'Anti-3 antibody, Month 5, ≥ 0.26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '77.7', 'upperLimit': '90.0'}, {'value': '78.7', 'groupId': 'OG001', 'lowerLimit': '71.2', 'upperLimit': '84.9'}]}]}, {'title': 'Anti-3 antibody, Month 5, ≥ 0.35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000', 'lowerLimit': '61.7', 'upperLimit': '77.0'}, {'value': '69.3', 'groupId': 'OG001', 'lowerLimit': '61.3', 'upperLimit': '76.6'}]}]}, {'title': 'Anti-4 antibody, Month 5, ≥ 0.15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '99.8'}, {'value': '98.1', 'groupId': 'OG001', 'lowerLimit': '94.6', 'upperLimit': '99.6'}]}]}, {'title': 'Anti-4 antibody, Month 5, ≥ 0.26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '92.7', 'upperLimit': '99.0'}, {'value': '91.8', 'groupId': 'OG001', 'lowerLimit': '86.3', 'upperLimit': '95.5'}]}]}, {'title': 'Anti-4 antibody, Month 5, ≥ 0.35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000', 'lowerLimit': '85.4', 'upperLimit': '95.0'}, {'value': '84.8', 'groupId': 'OG001', 'lowerLimit': '78.2', 'upperLimit': '90.0'}]}]}, {'title': 'Anti-5 antibody, Month 5, ≥ 0.15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000', 'lowerLimit': '93.6', 'upperLimit': '99.3'}, {'value': '96.8', 'groupId': 'OG001', 'lowerLimit': '92.8', 'upperLimit': '99.0'}]}]}, {'title': 'Anti-5 antibody, Month 5, ≥ 0.26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.6', 'groupId': 'OG000', 'lowerLimit': '88.5', 'upperLimit': '96.9'}, {'value': '86.7', 'groupId': 'OG001', 'lowerLimit': '80.4', 'upperLimit': '91.6'}]}]}, {'title': 'Anti-5 antibody, Month 5, ≥ 0.35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000', 'lowerLimit': '85.4', 'upperLimit': '95.0'}, {'value': '80.4', 'groupId': 'OG001', 'lowerLimit': '73.3', 'upperLimit': '86.3'}]}]}, {'title': 'Anti-6A antibody, Month 5, ≥ 0.15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '98.7', 'groupId': 'OG001', 'lowerLimit': '95.5', 'upperLimit': '99.8'}]}]}, {'title': 'Anti-6A antibody, Month 5, ≥ 0.26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '99.8'}, {'value': '94.3', 'groupId': 'OG001', 'lowerLimit': '89.5', 'upperLimit': '97.4'}]}]}, {'title': 'Anti-6A antibody, Month 5, ≥ 0.35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '94.5', 'upperLimit': '99.6'}, {'value': '91.8', 'groupId': 'OG001', 'lowerLimit': '86.3', 'upperLimit': '95.5'}]}]}, {'title': 'Anti-6B antibody, Month 5, ≥ 0.15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 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'98.3', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98.2', 'upperLimit': '100'}]}]}, {'title': 'Anti-19F antibody, Month 11-14, ≥0.35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98.2', 'upperLimit': '100'}]}]}, {'title': 'Anti-23F antibody, Month 11-14, ≥ 0.15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000', 'lowerLimit': '97.4', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98.2', 'upperLimit': '100'}]}]}, {'title': 'Anti-23F antibody, Month 11-14, ≥ 0.26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000', 'lowerLimit': '97.4', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98.2', 'upperLimit': '100'}]}]}, {'title': 'Anti-23F antibody, Month 11-14, ≥0.35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '95.3', 'upperLimit': '99.5'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98.2', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14)', 'description': 'The cut-off values are 0.15, 0.26, 0.35 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was perfomed on First three doses ATP for analysis of immunogenicity and on the Fourth dose ATP cohort for analysis of immunogenicity which included all evaluable subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'title': 'Pain, Hib-MenCY-TT/PedvaxHIB, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.2', 'groupId': 'OG000', 'lowerLimit': '38.4', 'upperLimit': '50.2'}, {'value': '61.2', 'groupId': 'OG001', 'lowerLimit': '55.3', 'upperLimit': '66.8'}]}]}, {'title': 'Pain, Pediarix, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.5', 'groupId': 'OG000', 'lowerLimit': '44.6', 'upperLimit': '56.5'}, {'value': '57.4', 'groupId': 'OG001', 'lowerLimit': '51.5', 'upperLimit': '63.1'}]}]}, {'title': 'Pain, Prevnar 13, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.3', 'groupId': 'OG000', 'lowerLimit': '40.4', 'upperLimit': '52.3'}, {'value': '58.8', 'groupId': 'OG001', 'lowerLimit': '52.9', 'upperLimit': '64.5'}]}]}, {'title': 'Pain, Hib-MenCY-TT/PedvaxHIB, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.6', 'groupId': 'OG000', 'lowerLimit': '39.6', 'upperLimit': '51.7'}, {'value': '56.8', 'groupId': 'OG001', 'lowerLimit': '50.8', 'upperLimit': '62.7'}]}]}, {'title': 'Pain, Pediarix, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000', 'lowerLimit': '39.2', 'upperLimit': '51.3'}, {'value': '55.8', 'groupId': 'OG001', 'lowerLimit': '49.7', 'upperLimit': '61.7'}]}]}, {'title': 'Pain, Prevnar 13, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000', 'lowerLimit': '38.5', 'upperLimit': '50.6'}, {'value': '56.0', 'groupId': 'OG001', 'lowerLimit': '49.9', 'upperLimit': '61.9'}]}]}, {'title': 'Pain, Hib-MenCY-TT/PedvaxHIB, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.8', 'groupId': 'OG000', 'lowerLimit': '32.9', 'upperLimit': '45.1'}]}]}, {'title': 'Pain, Pediarix, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000', 'lowerLimit': '36.7', 'upperLimit': '49.0'}, {'value': '50.8', 'groupId': 'OG001', 'lowerLimit': '44.6', 'upperLimit': '56.9'}]}]}, {'title': 'Pain, Prevnar 13, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.7', 'groupId': 'OG000', 'lowerLimit': '33.7', 'upperLimit': '45.9'}, {'value': '47.7', 'groupId': 'OG001', 'lowerLimit': '41.6', 'upperLimit': '53.9'}]}]}, {'title': 'Pain,Havrix , Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.8', 'groupId': 'OG000', 'lowerLimit': '38.4', 'upperLimit': '51.3'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '43.5', 'upperLimit': '56.5'}]}]}, {'title': 'Pain, Hib-MenCY-TT/PedvaxHIB, Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.3', 'groupId': 'OG000', 'lowerLimit': '36.0', 'upperLimit': '48.8'}, {'value': '56.2', 'groupId': 'OG001', 'lowerLimit': '49.7', 'upperLimit': '62.5'}]}]}, {'title': 'Pain, Prevnar 13, Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.5', 'groupId': 'OG000', 'lowerLimit': '35.2', 'upperLimit': '48.0'}, {'value': '46.7', 'groupId': 'OG001', 'lowerLimit': '40.3', 'upperLimit': '53.2'}]}]}, {'title': 'Redness, Hib-MenCY-TT/PedvaxHIB, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000', 'lowerLimit': '16.5', 'upperLimit': '26.3'}, {'value': '35.4', 'groupId': 'OG001', 'lowerLimit': '29.9', 'upperLimit': '41.2'}]}]}, {'title': 'Redness, Pediarix, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000', 'lowerLimit': '22.0', 'upperLimit': '32.7'}, {'value': '25.1', 'groupId': 'OG001', 'lowerLimit': '20.2', 'upperLimit': '30.5'}]}]}, {'title': 'Redness, Prevnar 13, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000', 'lowerLimit': '18.8', 'upperLimit': '29.0'}, {'value': '24.4', 'groupId': 'OG001', 'lowerLimit': '19.6', 'upperLimit': '29.8'}]}]}, {'title': 'Redness, Hib-MenCY-TT/PedvaxHIB, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000', 'lowerLimit': '24.8', 'upperLimit': '36.1'}, {'value': '41.4', 'groupId': 'OG001', 'lowerLimit': '35.5', 'upperLimit': '47.4'}]}]}, {'title': 'Redness, Pediarix, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.9', 'groupId': 'OG000', 'lowerLimit': '28.3', 'upperLimit': '39.9'}, {'value': '43.2', 'groupId': 'OG001', 'lowerLimit': '37.3', 'upperLimit': '49.2'}]}]}, {'title': 'Redness, Prevnar 13, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000', 'lowerLimit': '25.2', 'upperLimit': '36.5'}, {'value': '41.2', 'groupId': 'OG001', 'lowerLimit': '35.3', 'upperLimit': '47.2'}]}]}, {'title': 'Redness, Hib-MenCY-TT/PedvaxHIB, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.5', 'groupId': 'OG000', 'lowerLimit': '25.9', 'upperLimit': '37.6'}]}]}, {'title': 'Redness, Pediarix, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.2', 'groupId': 'OG000', 'lowerLimit': '32.3', 'upperLimit': '44.3'}, {'value': '50.4', 'groupId': 'OG001', 'lowerLimit': '44.2', 'upperLimit': '56.6'}]}]}, {'title': 'Redness, Prevnar 13, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.3', 'groupId': 'OG000', 'lowerLimit': '30.4', 'upperLimit': '42.4'}, {'value': '45.8', 'groupId': 'OG001', 'lowerLimit': '39.7', 'upperLimit': '52.1'}]}]}, {'title': 'Redness,Havrix , Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.6', 'groupId': 'OG000', 'lowerLimit': '32.4', 'upperLimit': '45.1'}, {'value': '43.8', 'groupId': 'OG001', 'lowerLimit': '37.5', 'upperLimit': '50.3'}]}]}, {'title': 'Redness, Hib-MenCY-TT/PedvaxHIB, Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.6', 'groupId': 'OG000', 'lowerLimit': '32.4', 'upperLimit': '45.1'}, {'value': '50.8', 'groupId': 'OG001', 'lowerLimit': '44.3', 'upperLimit': '57.3'}]}]}, {'title': 'Redness, Prevnar 13, Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.1', 'groupId': 'OG000', 'lowerLimit': '34.8', 'upperLimit': '47.6'}, {'value': '44.6', 'groupId': 'OG001', 'lowerLimit': '38.3', 'upperLimit': '51.1'}]}]}, {'title': 'Swelling, Hib-MenCY-TT/PedvaxHIB, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '15.5'}, {'value': '22.0', 'groupId': 'OG001', 'lowerLimit': '17.4', 'upperLimit': '27.2'}]}]}, {'title': 'Swelling, Pediarix, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000', 'lowerLimit': '14.3', 'upperLimit': '23.7'}, {'value': '16.2', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '20.9'}]}]}, {'title': 'Swelling, Prevnar 13, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '19.5'}, {'value': '16.2', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '20.9'}]}]}, {'title': 'Swelling, Hib-MenCY-TT/PedvaxHIB, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '23.6'}, {'value': '30.6', 'groupId': 'OG001', 'lowerLimit': '25.2', 'upperLimit': '36.4'}]}]}, {'title': 'Swelling, Pediarix, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000', 'lowerLimit': '17.3', 'upperLimit': '27.6'}, {'value': '36.3', 'groupId': 'OG001', 'lowerLimit': '30.7', 'upperLimit': '42.3'}]}]}, {'title': 'Swelling, Prevnar 13, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '17.7', 'upperLimit': '28.0'}, {'value': '28.9', 'groupId': 'OG001', 'lowerLimit': '23.6', 'upperLimit': '34.6'}]}]}, {'title': 'Swelling, Hib-MenCY-TT/PedvaxHIB, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '14.6', 'upperLimit': '24.6'}]}]}, {'title': 'Swelling, Pediarix, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000', 'lowerLimit': '23.9', 'upperLimit': '35.3'}, {'value': '37.9', 'groupId': 'OG001', 'lowerLimit': '32.0', 'upperLimit': '44.0'}]}]}, {'title': 'Swelling, Prevnar 13, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000', 'lowerLimit': '19.3', 'upperLimit': '30.1'}, {'value': '31.4', 'groupId': 'OG001', 'lowerLimit': '25.9', 'upperLimit': '37.4'}]}]}, {'title': 'Swelling,Havrix , Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000', 'lowerLimit': '19.9', 'upperLimit': '31.3'}, {'value': '26.0', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': '32.0'}]}]}, {'title': 'Swelling, Hib-MenCY-TT/PedvaxHIB, Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000', 'lowerLimit': '17.7', 'upperLimit': '28.6'}, {'value': '34.3', 'groupId': 'OG001', 'lowerLimit': '28.3', 'upperLimit': '40.6'}]}]}, {'title': 'Swelling, Prevnar 13, Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000', 'lowerLimit': '20.7', 'upperLimit': '32.2'}, {'value': '27.7', 'groupId': 'OG001', 'lowerLimit': '22.1', 'upperLimit': '33.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose', 'description': 'Solicited local adverse events include pain, redness and swelling at injection site.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose total vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reporting Any Solicited General AEs.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'title': 'Any Temperature (°C), Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '15.5'}, {'value': '20.6', 'groupId': 'OG001', 'lowerLimit': '16.1', 'upperLimit': '25.7'}]}]}, {'title': 'Any Temperature (°C), Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000', 'lowerLimit': '14.9', 'upperLimit': '24.6'}, {'value': '29.0', 'groupId': 'OG001', 'lowerLimit': '23.8', 'upperLimit': '34.7'}]}]}, {'title': 'Any Temperature (°C), Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '21.5'}, {'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '12.7', 'upperLimit': '22.1'}]}]}, {'title': 'Any Temperature (°C), Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '13.0'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '14.9'}]}]}, {'title': 'Irritability / Fussiness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.2', 'groupId': 'OG000', 'lowerLimit': '65.6', 'upperLimit': '76.4'}, {'value': '81.8', 'groupId': 'OG001', 'lowerLimit': '76.9', 'upperLimit': '86.0'}]}]}, {'title': 'Irritability / Fussiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '64.1', 'upperLimit': '75.3'}, {'value': '83.5', 'groupId': 'OG001', 'lowerLimit': '78.6', 'upperLimit': '87.6'}]}]}, {'title': 'Irritability / Fussiness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.0', 'groupId': 'OG000', 'lowerLimit': '59.9', 'upperLimit': '71.7'}, {'value': '69.4', 'groupId': 'OG001', 'lowerLimit': '63.5', 'upperLimit': '74.9'}]}]}, {'title': 'Irritability / Fussiness, Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.0', 'groupId': 'OG000', 'lowerLimit': '59.6', 'upperLimit': '71.9'}, {'value': '74.3', 'groupId': 'OG001', 'lowerLimit': '68.3', 'upperLimit': '79.7'}]}]}, {'title': 'Loss Of Appetite, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000', 'lowerLimit': '26.2', 'upperLimit': '37.3'}, {'value': '42.3', 'groupId': 'OG001', 'lowerLimit': '36.5', 'upperLimit': '48.2'}]}]}, {'title': 'Loss Of Appetite, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000', 'lowerLimit': '24.3', 'upperLimit': '35.5'}, {'value': '31.7', 'groupId': 'OG001', 'lowerLimit': '26.2', 'upperLimit': '37.5'}]}]}, {'title': 'Loss Of Appetite, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000', 'lowerLimit': '24.3', 'upperLimit': '35.7'}, {'value': '28.7', 'groupId': 'OG001', 'lowerLimit': '23.3', 'upperLimit': '34.5'}]}]}, {'title': 'Loss Of Appetite, Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.2', 'groupId': 'OG000', 'lowerLimit': '27.3', 'upperLimit': '39.5'}, {'value': '39.8', 'groupId': 'OG001', 'lowerLimit': '33.6', 'upperLimit': '46.3'}]}]}, {'title': 'Drowsiness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.9', 'groupId': 'OG000', 'lowerLimit': '59.1', 'upperLimit': '70.4'}, {'value': '70.1', 'groupId': 'OG001', 'lowerLimit': '64.5', 'upperLimit': '75.3'}]}]}, {'title': 'Drowsiness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.2', 'groupId': 'OG000', 'lowerLimit': '48.1', 'upperLimit': '60.2'}, {'value': '65.1', 'groupId': 'OG001', 'lowerLimit': '59.2', 'upperLimit': '70.7'}]}]}, {'title': 'Drowsiness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.9', 'groupId': 'OG000', 'lowerLimit': '42.7', 'upperLimit': '55.1'}, {'value': '52.5', 'groupId': 'OG001', 'lowerLimit': '46.3', 'upperLimit': '58.6'}]}]}, {'title': 'Drowsiness, Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000', 'lowerLimit': '37.6', 'upperLimit': '50.5'}, {'value': '48.5', 'groupId': 'OG001', 'lowerLimit': '42.1', 'upperLimit': '55.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose.', 'description': 'Solicited general AEs include fever \\[defined as temperature ≥38.0 degrees Celsius (°C) by any method\\], drowsiness, irritability/fussiness and loss of appetite.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose Total Vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reporting Any Unsolicited AEs.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'title': 'Dose 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.6', 'groupId': 'OG000', 'lowerLimit': '54.8', 'upperLimit': '66.2'}, {'value': '56.4', 'groupId': 'OG001', 'lowerLimit': '50.6', 'upperLimit': '62.1'}]}]}, {'title': 'Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.9', 'groupId': 'OG000', 'lowerLimit': '33.8', 'upperLimit': '46.3'}, {'value': '42.0', 'groupId': 'OG001', 'lowerLimit': '35.8', 'upperLimit': '48.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During 31 days (Day 0 to Day 30) after all vaccines post-primary (Dose 1-3) and post-fourth dose (Dose 4)', 'description': 'Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited adverse event.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose Total Vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reporting Any Serious Adverse Events (SAEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'OG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '5.2'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '6.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the entire study period (from Day 0 to Month 17-20)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose Total Vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'FG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '297'}, {'groupId': 'FG001', 'numSubjects': '303'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}, {'groupId': 'FG001', 'numSubjects': '230'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '73'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Loss of kaiser coverage', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost kaiser health plan unable to contac', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Mother lost custody of child', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Child was in care of grandmother', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'N/A for vaccine administration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '600 subjects were recruited from 27 centers in the United States. The study consists of 2 epochs: Epoch 001: starting at Day 0 and ending at the day preceding the 4th vaccination (Month 10-13) and Epoch 002: starting at Month 10-13 and ending at Month 17-20, 31 days after the 2nd Havrix vaccination', 'preAssignmentDetails': 'All enrolled subjects were included in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'BG000'}, {'value': '303', 'groupId': 'BG001'}, {'value': '600', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'BG001', 'title': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '297', 'groupId': 'BG000'}, {'value': '303', 'groupId': 'BG001'}, {'value': '600', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '8.6', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '8.6', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African Heritage / African American', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Asian - Central/South Asian Heritage', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Asian - East Asian Heritage', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Asian - Japanese Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian - South East Asian Heritage', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'White - Arabic / North African Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'White - Caucasian / European Heritage', 'categories': [{'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '419', 'groupId': 'BG002'}]}]}, {'title': 'Unspecified', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'dispFirstSubmitDate': '2016-12-06', 'completionDateStruct': {'date': '2016-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-16', 'studyFirstSubmitDate': '2013-10-31', 'dispFirstSubmitQcDate': '2016-12-06', 'resultsFirstSubmitDate': '2018-05-28', 'studyFirstSubmitQcDate': '2013-10-31', 'dispFirstPostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-28', 'studyFirstPostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 1.0 µg/mL', 'timeFrame': '1 month after the fourth dose for HibCY Group and 1 month after third dose for PedHIB Group [Month (M) 11-14]', 'description': 'Percentage of subjects with Anti-PRP antibody concentrations≥1.0 µg/mL were assessed.\n\nAnalysis of Immunogenicity is performed on blood sample (BS) sub-cohorts. Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch.'}, {'measure': 'Anti-rotavirus Serum Immunoglobulin A (IgA) Geometric Mean Concentrations (GMCs).', 'timeFrame': '2 months post-dose 2 of Rotarix (Month 4)', 'description': 'Anti-rotavirus serum IgA was assessed by ELISA, tabulated as GMCs and expressed in Units per mililiter (U/mL).Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.\n\nAssignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per a hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch'}, {'measure': 'Anti-Streptococcus (S) Pneumoniae GMCs', 'timeFrame': '1 month post-dose 3 of Prevnar 13 (Month 5)', 'description': 'Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL.\n\nAnalysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch.'}, {'measure': 'Percentage of Subjects With Anti-Hepatitis A (Anti-Havrix) Antibody Concentrations ≥ 15mIU/mL', 'timeFrame': '1 month post-dose 2 of Havrix (Month 17-20)', 'description': 'Percentage of subjects with Anti-Havrix (Anti-HAV) antibody concentrations was assessed. The cut-off value is ≥15 mIU/mL.\n\nAnalysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch'}, {'measure': 'Anti-S. Pneumoniae GMCs', 'timeFrame': '1 month post-dose 4 of Prevnar 13 (Month 11-14)', 'description': 'Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL.\n\nAnalysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects With Anti-PRP Antibody Concentrations ≥0.15 µg/mL.', 'timeFrame': '2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Months 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)]', 'description': 'The cut-off value for this assay was 0.15 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.'}, {'measure': 'Anti-PRP GMCs≥ 0.15 µg/mL.', 'timeFrame': '2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Month 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)]', 'description': 'Anti-PRP antibody concentrations were assessed by Enzyme-Linked-Immunosorbent-Assay (ELISA), tabulated as Geometric Mean Concentrations (GMCs) and expressed in micrograms per mililiter (µg/mL).The cut-off value for this assay was 0.15 µg/mL.\n\nAnalysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.'}, {'measure': 'Percentage of Subjects With Anti-PRP Antibody Concentrations ≥1.0 µg/mL', 'timeFrame': '2 months post-dose 2 [PedHib group only (Month 4)] and 1 month postdose 3 [HibCY group only (Month 5)].', 'description': 'The cut-off value for this assay was 1.0 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.'}, {'measure': 'Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32.', 'timeFrame': '1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14).', 'description': 'The cut off values are dilutions of 1:8, 1:16 and 1:32. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.'}, {'measure': 'Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY', 'timeFrame': '1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14).', 'description': 'The cut-off values are dilutions of 1:8, 1:16 and 1:32. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.'}, {'measure': 'Percentage of Subjects With Anti-rotavirus IgA Antibody Concentrations ≥ 20 Units (U)/mL', 'timeFrame': '2 month post-dose 2 of Rotarix (Month 4)', 'description': 'The cut-off value is 20 Units (U)/mL Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.'}, {'measure': 'Percentage of Subjects With Anti-HAV Antibodies ≥ 15 mIU/mL', 'timeFrame': '1 month post-dose 1 of Havrix (Month 11-14)', 'description': 'The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.'}, {'measure': 'Anti-HAV GMCs ≥ 15 mIU/mL', 'timeFrame': '1 month post-dose 1 of HAV (M11-14).', 'description': 'The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups'}, {'measure': 'GMCs for Anti-HAV Antibodies ≥15mIU/mL.', 'timeFrame': '1 month post-dose 2 of HAV (Month 17-20).', 'description': 'The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups'}, {'measure': 'Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F', 'timeFrame': '1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14)', 'description': 'The cut-off values are 0.15, 0.26, 0.35 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups'}, {'measure': 'Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE).', 'timeFrame': '4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose', 'description': 'Solicited local adverse events include pain, redness and swelling at injection site.'}, {'measure': 'Percentage of Subjects Reporting Any Solicited General AEs.', 'timeFrame': '4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose.', 'description': 'Solicited general AEs include fever \\[defined as temperature ≥38.0 degrees Celsius (°C) by any method\\], drowsiness, irritability/fussiness and loss of appetite.'}, {'measure': 'Percentage of Subjects Reporting Any Unsolicited AEs.', 'timeFrame': 'During 31 days (Day 0 to Day 30) after all vaccines post-primary (Dose 1-3) and post-fourth dose (Dose 4)', 'description': 'Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited adverse event.'}, {'measure': 'Percentage of Subjects Reporting Any Serious Adverse Events (SAEs).', 'timeFrame': 'During the entire study period (from Day 0 to Month 17-20)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}]}, 'conditionsModule': {'keywords': ['Conjugate', 'Immunogenicity', 'Hib-MenCY-TT vaccine', 'Haemophilus type b', 'Safety', 'Reactogenicity'], 'conditions': ['Neisseria Meningitidis', 'Haemophilus Influenzae Type b']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' Hib-MenCY-TT (MenHibrix®) vaccine co-administered with Rotarix, Prevnar 13 and Havrix as compared to PedvaxHIB co-administered with Rotarix, Prevnar 13 and Havrix in infants and toddlers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects' parent(s)/Legally Acceptable Representative(s) \\[LAR(s)\\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.\n* A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.\n* Written informed consent obtained from the parent(s)/LAR(s) of the subject.\n* Healthy subjects as established by medical history and clinical examination before entering into the study.\n* Born full-term (i.e. born after a gestation period of at least 37 weeks inclusive).\n* Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.\n\nExclusion Criteria:\n\n* Child in care.\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine or planned use during the study period.\n* Chronic administration of immunosuppressants or other immune-modifying drugs since birth prior to the first vaccine dose. Inhaled and topical steroids are allowed.\n* Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, rotavirus, pneumococcus, hepatitis A and/or poliovirus; more than one previous dose of hepatitis B vaccine.\n* Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of vaccines. Subjects may receive inactivated influenza vaccine or pandemic influenza vaccines any time during the study according to the national recommendation. Measles, mumps, rubella and varicella vaccination are allowed 30 days before or 30 days after the final vaccination of Hib-MenCY-TT or PedvaxHIB.\n* History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B, hepatitis A, rotavirus, and/or poliovirus disease.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber. Hypersensitivity to any component of the vaccines, including gelatin or neomycin.\n* Major congenital defects or serious chronic illnesses.\n* History of any neurologic disorders or seizures. A single, simple febrile seizure is allowed.\n* Subjects with history of intussusceptions or uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusceptions.\n* Acute disease and/or fever at the time of enrollment.\n* Administration of immunoglobulins and/or blood products since birth or planned administration during the study period."}, 'identificationModule': {'nctId': 'NCT01978093', 'briefTitle': "Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine 792014 Compared to Merck & Co, Inc. Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Vaccine in Healthy Infants and Toddlers", 'orgStudyIdInfo': {'id': '112931'}, 'secondaryIdInfos': [{'id': '2013-003459-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HibCY Group', 'description': 'Subjects received 4 doses of Hib-MenCY-TT (MenHibrix®) vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.', 'interventionNames': ['Biological: Hib-MenCY-TT (MenHibrix®)', 'Biological: Pediarix®', 'Biological: Rotarix®', 'Biological: Prevnar 13®', 'Biological: Havrix®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PedHIB Group', 'description': 'Subjects received 3 doses of PedvaxHIB® vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.', 'interventionNames': ['Biological: Pediarix®', 'Biological: Rotarix®', 'Biological: Prevnar 13®', 'Biological: PedvaxHIB®', 'Biological: Havrix®']}], 'interventions': [{'name': 'Hib-MenCY-TT (MenHibrix®)', 'type': 'BIOLOGICAL', 'description': '4 doses administered intramuscularly (IM) in the right upper anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13 in the HibCY Group.', 'armGroupLabels': ['HibCY Group']}, {'name': 'Pediarix®', 'type': 'BIOLOGICAL', 'description': '3 doses administered IM in the left upper anterolateral thigh at Day 0, Month 2 and Month 4. 2 doses administered IM in the left upper anterolateral thigh at Day 0 and Month 2 and 1 dose administered IM in the right upper anterolateral thigh at Month 4 in the PedHIB Group.', 'armGroupLabels': ['HibCY Group', 'PedHIB Group']}, {'name': 'Rotarix®', 'type': 'BIOLOGICAL', 'description': '2 doses administered orally at Day 0 and Month 2 each in the HibCY Group and PedHIB Group.', 'armGroupLabels': ['HibCY Group', 'PedHIB Group']}, {'name': 'Prevnar 13®', 'type': 'BIOLOGICAL', 'description': '4 doses administered IM in the left lower anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13 each in the HibCY Group and PedHIB Group.', 'armGroupLabels': ['HibCY Group', 'PedHIB Group']}, {'name': 'PedvaxHIB®', 'type': 'BIOLOGICAL', 'description': '3 doses administered IM in the right upper anterolateral thigh at Day 0, Month 2 and Month 10-13 in the PedHIB Group.', 'armGroupLabels': ['PedHIB Group']}, {'name': 'Havrix®', 'type': 'BIOLOGICAL', 'description': '2 doses administered IM in the left upper anterolateral thigh at Month 10-13 and Month 16-19 each in the HibCY Group and PedHIB Group.', 'armGroupLabels': ['HibCY Group', 'PedHIB Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '93726', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92648', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '90723', 'city': 'Paramount', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.88946, 'lon': -118.15979}}, {'zip': '94588', 'city': 'Pleasanton', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.66243, 'lon': -121.87468}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '95823', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95119', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '95051', 'city': 'Santa Clara', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.35411, 'lon': -121.95524}}, {'zip': '94596', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '02721', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '01801', 'city': 'Woburn', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.47926, 'lon': -71.15228}}, {'zip': '49120', 'city': 'Niles', 'state': 'Michigan', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.82977, 'lon': -86.25418}}, {'zip': '49127', 'city': 'Stevensville', 'state': 'Michigan', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.01449, 'lon': -86.51947}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '44121', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '45406', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '16148', 'city': 'Hermitage', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.23339, 'lon': -80.44868}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '84041', 'city': 'Layton', 'state': 'Utah', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.06022, 'lon': -111.97105}}, {'zip': '84124', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '84057', 'city': 'Orem', 'state': 'Utah', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.2969, 'lon': -111.69465}}, {'zip': '84067', 'city': 'Roy', 'state': 'Utah', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.16161, 'lon': -112.02633}}, {'zip': '84075', 'city': 'Syracuse', 'state': 'Utah', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.08939, 'lon': -112.06467}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}