Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-01-04 @ 6:21 AM
Study NCT ID:
NCT03207750
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2017-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012400', 'term': 'Rotavirus Infections'}], 'ancestors': [{'id': 'D012088', 'term': 'Reoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C492457', 'term': 'RIX4414 vaccine'}, {'id': 'C472675', 'term': 'PEDIARIX'}, {'id': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'D017325', 'term': 'Hepatitis B Vaccines'}, {'id': 'D011054', 'term': 'Poliovirus Vaccine, Inactivated'}, {'id': 'C514867', 'term': 'Hiberix'}, {'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}, {'id': 'C028581', 'term': 'CRM197 (non-toxic variant of diphtheria toxin)'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D015164', 'term': 'Vaccines, Inactivated'}, {'id': 'D023321', 'term': 'Poliovirus Vaccines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after each HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 10).', 'eventGroups': [{'id': 'EG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.', 'otherNumAtRisk': 632, 'deathsNumAtRisk': 632, 'otherNumAffected': 571, 'seriousNumAtRisk': 632, 'deathsNumAffected': 1, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).', 'otherNumAtRisk': 640, 'deathsNumAtRisk': 640, 'otherNumAffected': 589, 'seriousNumAtRisk': 640, 'deathsNumAffected': 0, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankyloglossia congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Birth mark', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congenital musculoskeletal anomaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congenital torticollis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dacryostenosis congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Macrocephaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Plagiocephaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Otorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dacryostenosis acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eyelid irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal faeces', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 185, 'numAffected': 126}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 164, 'numAffected': 113}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infantile colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infantile vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infrequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucous stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-tussive vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pylorospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 208, 'numAffected': 155}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 197, 'numAffected': 156}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 116, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 133, 'numAffected': 116}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaccination site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Milk allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atypical pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Candida nappy rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corona virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 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'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid intake reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxic-ischaemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngomalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metapneumovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngeal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory syncytial virus bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure like phenomena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sudden infant death syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 632, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 640, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Above or Equal to Cut-off Value.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'title': 'Anti-D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}, {'value': '486', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '478', 'groupId': 'OG000'}, {'value': '486', 'groupId': 'OG001'}]}]}, {'title': 'Anti-T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '486', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in anti-D concentration', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '0.79', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 0.1 IU/mL) of anti-D antibodies.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided asymptotic standardized 95% Confidence Interval (CI) for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-D antibodies should be ≥-10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in anti-T concentration', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '0.77', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 0.1 IU/mL) of anti-T antibodies.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided asymptotic standardized 95% Confidence Interval (CI) for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-T antibodies should be ≥-10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Immunogenicity was assessed using Enzyme Linked Immunosorbent Assay (ELISA) in terms of seroprotection rates against diphtheria toxoid. A seroprotected subject is a subject whose antibody concentration is greater than or equal to (≥) the level defining clinical protection. The following seroprotection thresholds were applicable:anti-D antibody concentrations ≥ 0.1 International Units/milliliter (IU/mL), anti-T antibody concentrations ≥ 0.1 IU/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Per protocol set (PPS) for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above or Equal to Cut-off Value.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'categories': [{'measurements': [{'value': '457', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in anti-HB concentration', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.65', 'ciLowerLimit': '-1.90', 'ciUpperLimit': '0.16', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 10 mIU/mL) of anti-HB antibodies.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-HB antibodies should be ≥-10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Immunogenicity was assessed using ChemiLuminescence ImmunoAssay (CLIA) in terms of seroprotection rates against Hepatitis B. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-HB antibody concentrations ≥ 10 milli International Units/milliliter (mIU/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects With Anti-polio Virus Types 1, 2 and 3 Antibody Titers Above or Equal to Cut-off Value.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '487', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'title': 'Anti-Polio 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '487', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '477', 'groupId': 'OG000'}, {'value': '486', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '464', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '463', 'groupId': 'OG000'}, {'value': '478', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Polio 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '439', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in anti-polio 1 concentration', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '1.15', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 1 antibodies.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 1 antibodies should be ≥-5%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in anti-polio 2 concentration', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-1.02', 'ciUpperLimit': '0.98', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 2 antibodies.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 2 antibodies should be ≥-5%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in anti-polio 3 concentration', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '0.84', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 3 antibodies.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 3 antibodies should be ≥-5%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Immunogenicity was assessed using virus micro-neutralization test in terms of seroprotection rates against polio virus types 1, 2 and 3. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-polio virus types 1, 2 and 3 types antibody titers ≥ 8 Estimated Dose 50% (ED50).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.'}, {'type': 'PRIMARY', 'title': 'Immunogenicity in Terms of Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'title': 'Anti-PT', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000', 'lowerLimit': '47.8', 'upperLimit': '54.5'}, {'value': '54.2', 'groupId': 'OG001', 'lowerLimit': '51.3', 'upperLimit': '57.4'}]}]}, {'title': 'Anti-FHA', 'categories': [{'measurements': [{'value': '107.3', 'groupId': 'OG000', 'lowerLimit': '101.4', 'upperLimit': '113.5'}, {'value': '107.7', 'groupId': 'OG001', 'lowerLimit': '101.6', 'upperLimit': '114.1'}]}]}, {'title': 'Anti-PRN', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '50.1', 'upperLimit': '60.4'}, {'value': '56.6', 'groupId': 'OG001', 'lowerLimit': '51.9', 'upperLimit': '61.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.03', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-PT antibodies.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'ANOVA model that included the vaccine group as fixed effect.', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-PT antibodies should be ≥ 0.67.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.08', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-FHA antibodies.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'ANOVA model that included the vaccine group as fixed effect.', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-FHA antibodies should be ≥ 0.67.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.10', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-PRN antibodies.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'ANOVA model that included the vaccine group as fixed effect.', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-PRN antibodies should be ≥ 0.67.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Antibody concentrations against PT, FHA and PRN were determined and expressed as Geometric Mean Concentrations (GMCs).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.'}, {'type': 'PRIMARY', 'title': 'Immunogenicity in Terms of Anti-pneumococcal Serotypes (Anti-PnPS) Antibody Concentrations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'title': 'Anti-PnPS 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.95', 'groupId': 'OG000', 'lowerLimit': '1.81', 'upperLimit': '2.10'}, {'value': '1.89', 'groupId': 'OG001', 'lowerLimit': '1.76', 'upperLimit': '2.03'}]}]}, {'title': 'Anti-PnPS 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.53', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '0.57'}, {'value': '0.53', 'groupId': 'OG001', 'lowerLimit': '0.49', 'upperLimit': '0.57'}]}]}, {'title': 'Anti-PnPS 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.24', 'groupId': 'OG000', 'lowerLimit': '1.16', 'upperLimit': '1.34'}, {'value': '1.25', 'groupId': 'OG001', 'lowerLimit': '1.18', 'upperLimit': '1.34'}]}]}, {'title': 'Anti-PnPS 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '459', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.28', 'groupId': 'OG000', 'lowerLimit': '1.17', 'upperLimit': '1.39'}, {'value': '1.22', 'groupId': 'OG001', 'lowerLimit': '1.13', 'upperLimit': '1.31'}]}]}, {'title': 'Anti-PnPS 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.84', 'groupId': 'OG000', 'lowerLimit': '2.64', 'upperLimit': '3.05'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2.61', 'upperLimit': '3.00'}]}]}, {'title': 'Anti-PnPS 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.93', 'groupId': 'OG000', 'lowerLimit': '1.72', 'upperLimit': '2.15'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1.80', 'upperLimit': '2.22'}]}]}, {'title': 'Anti-PnPS 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.01', 'groupId': 'OG000', 'lowerLimit': '2.83', 'upperLimit': '3.21'}, {'value': '3.04', 'groupId': 'OG001', 'lowerLimit': '2.86', 'upperLimit': '3.22'}]}]}, {'title': 'Anti-PnPS 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.68', 'groupId': 'OG000', 'lowerLimit': '1.56', 'upperLimit': '1.81'}, {'value': '1.63', 'groupId': 'OG001', 'lowerLimit': '1.52', 'upperLimit': '1.75'}]}]}, {'title': 'Anti-PnPS 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.27', 'groupId': 'OG000', 'lowerLimit': '5.74', 'upperLimit': '6.84'}, {'value': '6.26', 'groupId': 'OG001', 'lowerLimit': '5.75', 'upperLimit': '6.82'}]}]}, {'title': 'Anti-PnPS 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.81', 'groupId': 'OG000', 'lowerLimit': '1.68', 'upperLimit': '1.95'}, {'value': '1.76', 'groupId': 'OG001', 'lowerLimit': '1.64', 'upperLimit': '1.89'}]}]}, {'title': 'Anti-PnPS 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.87', 'groupId': 'OG000', 'lowerLimit': '1.73', 'upperLimit': '2.02'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.68', 'upperLimit': '1.93'}]}]}, {'title': 'Anti-PnPS 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.94', 'groupId': 'OG000', 'lowerLimit': '2.76', 'upperLimit': '3.12'}, {'value': '2.85', 'groupId': 'OG001', 'lowerLimit': '2.69', 'upperLimit': '3.03'}]}]}, {'title': 'Anti-PnPS 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.14', 'groupId': 'OG000', 'lowerLimit': '1.04', 'upperLimit': '1.24'}, {'value': '1.16', 'groupId': 'OG001', 'lowerLimit': '1.07', 'upperLimit': '1.26'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.14', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 1.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'ANOVA model that included the vaccine group as fixed effect.', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 1 should be ≥ 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.11', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 3.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'ANOVA model that included the vaccine group as fixed effect.', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 3 should be ≥ 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.09', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 4.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'ANOVA model that included the vaccine group as fixed effect.', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 4 should be ≥ 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.17', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 5.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'ANOVA model that included the vaccine group as fixed effect.', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 5 should be ≥ 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.12', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 6A.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'ANOVA model that included the vaccine group as fixed effect.', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 6A should be ≥ 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.12', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 6B.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'ANOVA model that included the vaccine group as fixed effect.', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 6B should be ≥ 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.08', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 7F.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'ANOVA model that included the vaccine group as fixed effect.', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 7F should be ≥ 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.14', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 9V.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'ANOVA model that included the vaccine group as fixed effect.', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 9V should be ≥ 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.13', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 14.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'ANOVA model that included the vaccine group as fixed effect.', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 14 should be ≥ 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.14', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 18C.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'ANOVA model that included the vaccine group as fixed effect.', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 18C should be ≥ 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.15', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 19A.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'ANOVA model that included the vaccine group as fixed effect.', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 19A should be ≥ 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.12', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 19F.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'ANOVA model that included the vaccine group as fixed effect.', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 19F should be ≥ 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.10', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 23F.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'ANOVA model that included the vaccine group as fixed effect.', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 23F should be ≥ 0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Antibody concentrations against pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were determined and expressed as GMCs in micrograms per milliliter (µg/mL).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 0.15 µg/mL.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'categories': [{'measurements': [{'value': '473', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in anti-PRP concentration', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-1.94', 'ciUpperLimit': '2.28', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with concentrations (≥ 0.15 µg/mL) of anti-PRP antibodies.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentrations (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-PRP antibodies should be ≥-5%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 0.15 µg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 1.0 µg/mL.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'categories': [{'measurements': [{'value': '394', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in anti-PRP concentration', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.88', 'ciLowerLimit': '-5.75', 'ciUpperLimit': '3.99', 'groupDescription': 'Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with concentrations (≥ 1.0 µg/mL) of anti-PRP antibodies.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentrations (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-PRP antibodies should be ≥-10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 1.0 µg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Seroresponse to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'title': 'Anti-PT', 'categories': [{'measurements': [{'value': '440', 'groupId': 'OG000'}, {'value': '470', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA', 'categories': [{'measurements': [{'value': '466', 'groupId': 'OG000'}, {'value': '470', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRN', 'categories': [{'measurements': [{'value': '455', 'groupId': 'OG000'}, {'value': '470', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'To rule out 10% decrease in seroresponse to PT antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \\& the posterior probability of the cut-off in HRV Lyophilized group', 'nonInferiorityComment': 'p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \\<=0.025 for PT antigen.'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'To rule out 10% decrease in seroresponse to FHA antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \\& the posterior probability of the cut-off in HRV lyophilized group', 'nonInferiorityComment': 'p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \\<=0.025 for FHA antigen.'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'To rule out 10% decrease in seroresponse to PRN antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \\& the posterior probability of the cut-off in HRV Lyophilized group', 'nonInferiorityComment': 'p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \\<=0.025 for PRN antigen.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Seroresponse is defined as the percentage of subjects showing an antibody concentration above a threshold that leads to 95% seroresponse in the HRV lyophilized Group. The cut-offs used were as follows: anti-PT (18.566 IU/mL), anti-FHA (35.711 IU/mL) and anti-PRN (11.034 IU/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects With Anti-Rota Virus Immunoglobulin A (Anti-RV IgA) Antibody Concentrations Above or Equal to Cut-off Value of 20 Units/Milliliter (U/mL).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'categories': [{'measurements': [{'value': '318', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 5 (Three months after Dose 2 of HRV vaccine)', 'description': 'Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies. The cut off used was ≥ 20 U/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects With Anti-RV IgA Antibody Concentrations Above or Equal to Cut-off Value of 90 U/mL.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 5 (Three months after Dose 2 of HRV vaccine)', 'description': 'Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies. The cut off used was ≥ 90 U/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above or Equal to Cut-off Value.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'title': 'Anti-PT', 'categories': [{'measurements': [{'value': '485', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA', 'categories': [{'measurements': [{'value': '486', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRN', 'categories': [{'measurements': [{'value': '486', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Immunogenicity was assessed using ELISA technique in terms of seropositivity against PT, FHA and PRN antibodies. The cut-offs for antibodies were the Lower Limit Of Quantification (LLOQ) of the assays which were ≥ 2.693 IU/mL (anti-PT), ≥ 2.046 IU/mL (anti-FHA) and ≥ 2.187 IU/mL (anti-PRN).\n\nThe Limit of Quantification is the lowest analyte concentration that can be quantitatively detected with a stated accuracy and precision, and LLOQ is the lowest standard curve point obtained by extrapolation, that can still be used for quantification.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects With Anti-PnPS Antibody Concentrations Above or Equal to Cut-off Value.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'title': 'Anti-PnPS 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '442', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PnPS 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '317', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PnPS 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '434', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PnPS 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '459', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '409', 'groupId': 'OG000'}, {'value': '424', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PnPS 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '441', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PnPS 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '407', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PnPS 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PnPS 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '431', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PnPS 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '441', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PnPS 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '436', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PnPS 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '438', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PnPS 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '448', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PnPS 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '409', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Immunogenicity was assessed using ELISA technique in terms of seropositivity against Pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) antibodies. The cut-off used was ≥ 0.35 µg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'title': 'Anti-D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}, {'value': '486', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.85', 'groupId': 'OG000', 'lowerLimit': '1.72', 'upperLimit': '1.98'}, {'value': '1.88', 'groupId': 'OG001', 'lowerLimit': '1.75', 'upperLimit': '2.02'}]}]}, {'title': 'Anti-T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.88', 'groupId': 'OG000', 'lowerLimit': '1.75', 'upperLimit': '2.02'}, {'value': '1.86', 'groupId': 'OG001', 'lowerLimit': '1.74', 'upperLimit': '1.99'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Antibody concentrations against diphtheria and tetanus were determined and expressed as GMCs. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity in Terms of Anti-PRP Antibody Concentrations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.41', 'groupId': 'OG000', 'lowerLimit': '3.82', 'upperLimit': '5.09'}, {'value': '4.28', 'groupId': 'OG001', 'lowerLimit': '3.71', 'upperLimit': '4.94'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Antibody concentrations against PRP were determined and expressed as GMCs. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity in Terms of Anti-HBs Antibody Concentrations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'categories': [{'measurements': [{'value': '2031.3', 'groupId': 'OG000', 'lowerLimit': '1834.6', 'upperLimit': '2249.0'}, {'value': '2168.9', 'groupId': 'OG001', 'lowerLimit': '1977.5', 'upperLimit': '2378.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Antibody concentrations against Hepatitis B were determined and expressed as GMCs. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity in Terms of Anti-poliovirus Types 1, 2 and 3 Antibody Titers.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '487', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'title': 'Anti-Polio 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '487', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '747.2', 'groupId': 'OG000', 'lowerLimit': '673.5', 'upperLimit': '828.8'}, {'value': '728.2', 'groupId': 'OG001', 'lowerLimit': '656.3', 'upperLimit': '808.0'}]}]}, {'title': 'Anti-Polio 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '464', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '659.6', 'groupId': 'OG000', 'lowerLimit': '587.9', 'upperLimit': '740.0'}, {'value': '699.3', 'groupId': 'OG001', 'lowerLimit': '627.7', 'upperLimit': '779.0'}]}]}, {'title': 'Anti-Polio 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1228.7', 'groupId': 'OG000', 'lowerLimit': '1100.3', 'upperLimit': '1372.1'}, {'value': '1291.6', 'groupId': 'OG001', 'lowerLimit': '1159.1', 'upperLimit': '1439.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Antibody concentrations against Poliovirus types 1, 2 and 3 were determined and expressed as Geometric Mean Titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Solicited General Adverse Events (AEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'title': 'Cough / Runny Nose (Dose 1), Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}]}, {'title': 'Cough / Runny Nose (Dose 2), Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '607', 'groupId': 'OG000'}, {'value': '609', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}]}, {'title': 'Cough / Runny Nose (Across doses), Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '305', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea (Dose 1), Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea (Dose 2), Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '607', 'groupId': 'OG000'}, {'value': '609', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea (Across doses), Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Fever (Dose 1), ≥ 38.0°C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Fever (Dose 2), ≥ 38.0°C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '607', 'groupId': 'OG000'}, {'value': '609', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Fever (Across doses), ≥ 38.0°C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}, {'title': 'Irritability / Fussiness (Dose 1), Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '448', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}]}, {'title': 'Irritability / Fussiness (Dose 2), Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '607', 'groupId': 'OG000'}, {'value': '609', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '440', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}]}]}, {'title': 'Irritability / Fussiness (Across doses), Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '523', 'groupId': 'OG000'}, {'value': '522', 'groupId': 'OG001'}]}]}, {'title': 'Loss of appetite (Dose 1), Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}]}, {'title': 'Loss of appetite (Dose 2), Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '607', 'groupId': 'OG000'}, {'value': '609', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}]}, {'title': 'Loss of appetite (Across doses), Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '292', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting (Dose 1), Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting (Dose 2), Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '607', 'groupId': 'OG000'}, {'value': '609', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting (Across doses), Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 8-day (Days 1-8) follow-up period after each HRV vaccination.', 'description': 'Assessed solicited general AEs were cough/runny nose; diarrhoea; fever measured by 3 routes which were oral, axillary and rectal, defined as temperature ≥ 38.0 degrees Celsius (°C); irritability; loss of appetite and vomiting. Any = any solicited general AE irrespective of its intensity grade and relationship to vaccination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Exposed set (ES). The ES included all subjects with at least one study vaccine administration documented. A safety analysis based on the ES included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Unsolicited AEs.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'categories': [{'measurements': [{'value': '294', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 31-day (Days 1-31) follow-up period after each HRV vaccination.', 'description': "Unsolicited AEs assessed include any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any= Any unsolicited AE irrespective of its intensity grade and relationship to vaccination.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Exposed set (ES). The ES included all subjects with at least one study vaccine administration documented. A safety analysis based on the ES included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Serious Adverse Events (SAEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'OG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (Day 1 to Month 10)', 'description': 'SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Exposed set (ES). The ES included all subjects with at least one study vaccine administration documented. A safety analysis based on the ES included all vaccinated subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'FG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '632'}, {'groupId': 'FG001', 'numSubjects': '640'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '574'}, {'groupId': 'FG001', 'numSubjects': '574'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '66'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'CONSENT WITHDRAWAL, NOT DUE TO AN AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'MIGRATED / MOVED FROM THE STUDY AREA', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT WILLING TO PARTICIPATE THIS VISIT', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT WILLING / NOT ABLE TO BE CONTACTED', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'OTHER, NOT SPECIFIED', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The study was conducted at 48 centers in the United States (US).', 'preAssignmentDetails': 'Out of 1280 subjects enrolled in the study, 7 subjects did not receive any study treatment and 1 subject was eliminated from all analyses as there was a deviation in informed consent.\n\n1272 subjects were vaccinated and included in the Exposed Set, 1148 subjects completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'BG000'}, {'value': '640', 'groupId': 'BG001'}, {'value': '1272', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HRV Porcine Circovirus (PCV)-Free Liquid Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.'}, {'id': 'BG001', 'title': 'HRV Lyophilized Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '8.7', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '8.7', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '308', 'groupId': 'BG000'}, {'value': '309', 'groupId': 'BG001'}, {'value': '617', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '324', 'groupId': 'BG000'}, {'value': '331', 'groupId': 'BG001'}, {'value': '655', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian Or Alaska Native', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Black Or African American', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian Or Other Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '468', 'groupId': 'BG000'}, {'value': '471', 'groupId': 'BG001'}, {'value': '939', 'groupId': 'BG002'}]}]}, {'title': 'Other, not specified', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-27', 'size': 2605230, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-08T10:26', 'hasProtocol': True}, {'date': '2017-08-01', 'size': 952306, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-08T10:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-07', 'studyFirstSubmitDate': '2017-06-16', 'resultsFirstSubmitDate': '2019-10-08', 'studyFirstSubmitQcDate': '2017-06-30', 'lastUpdatePostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-08', 'studyFirstPostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Above or Equal to Cut-off Value.', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Immunogenicity was assessed using Enzyme Linked Immunosorbent Assay (ELISA) in terms of seroprotection rates against diphtheria toxoid. A seroprotected subject is a subject whose antibody concentration is greater than or equal to (≥) the level defining clinical protection. The following seroprotection thresholds were applicable:anti-D antibody concentrations ≥ 0.1 International Units/milliliter (IU/mL), anti-T antibody concentrations ≥ 0.1 IU/mL.'}, {'measure': 'Number of Seroprotected Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above or Equal to Cut-off Value.', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Immunogenicity was assessed using ChemiLuminescence ImmunoAssay (CLIA) in terms of seroprotection rates against Hepatitis B. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-HB antibody concentrations ≥ 10 milli International Units/milliliter (mIU/mL).'}, {'measure': 'Number of Seroprotected Subjects With Anti-polio Virus Types 1, 2 and 3 Antibody Titers Above or Equal to Cut-off Value.', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Immunogenicity was assessed using virus micro-neutralization test in terms of seroprotection rates against polio virus types 1, 2 and 3. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-polio virus types 1, 2 and 3 types antibody titers ≥ 8 Estimated Dose 50% (ED50).'}, {'measure': 'Immunogenicity in Terms of Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations.', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Antibody concentrations against PT, FHA and PRN were determined and expressed as Geometric Mean Concentrations (GMCs).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.'}, {'measure': 'Immunogenicity in Terms of Anti-pneumococcal Serotypes (Anti-PnPS) Antibody Concentrations.', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Antibody concentrations against pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were determined and expressed as GMCs in micrograms per milliliter (µg/mL).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.'}, {'measure': 'Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 0.15 µg/mL.', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 0.15 µg/mL.'}, {'measure': 'Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 1.0 µg/mL.', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 1.0 µg/mL.'}, {'measure': 'Number of Subjects With Seroresponse to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies.', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Seroresponse is defined as the percentage of subjects showing an antibody concentration above a threshold that leads to 95% seroresponse in the HRV lyophilized Group. The cut-offs used were as follows: anti-PT (18.566 IU/mL), anti-FHA (35.711 IU/mL) and anti-PRN (11.034 IU/mL).'}], 'secondaryOutcomes': [{'measure': 'Number of Seropositive Subjects With Anti-Rota Virus Immunoglobulin A (Anti-RV IgA) Antibody Concentrations Above or Equal to Cut-off Value of 20 Units/Milliliter (U/mL).', 'timeFrame': 'At Month 5 (Three months after Dose 2 of HRV vaccine)', 'description': 'Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies. The cut off used was ≥ 20 U/mL.'}, {'measure': 'Number of Seropositive Subjects With Anti-RV IgA Antibody Concentrations Above or Equal to Cut-off Value of 90 U/mL.', 'timeFrame': 'At Month 5 (Three months after Dose 2 of HRV vaccine)', 'description': 'Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies. The cut off used was ≥ 90 U/mL.'}, {'measure': 'Number of Seropositive Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above or Equal to Cut-off Value.', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Immunogenicity was assessed using ELISA technique in terms of seropositivity against PT, FHA and PRN antibodies. The cut-offs for antibodies were the Lower Limit Of Quantification (LLOQ) of the assays which were ≥ 2.693 IU/mL (anti-PT), ≥ 2.046 IU/mL (anti-FHA) and ≥ 2.187 IU/mL (anti-PRN).\n\nThe Limit of Quantification is the lowest analyte concentration that can be quantitatively detected with a stated accuracy and precision, and LLOQ is the lowest standard curve point obtained by extrapolation, that can still be used for quantification.'}, {'measure': 'Number of Seropositive Subjects With Anti-PnPS Antibody Concentrations Above or Equal to Cut-off Value.', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Immunogenicity was assessed using ELISA technique in terms of seropositivity against Pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) antibodies. The cut-off used was ≥ 0.35 µg/mL.'}, {'measure': 'Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations.', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Antibody concentrations against diphtheria and tetanus were determined and expressed as GMCs. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.'}, {'measure': 'Immunogenicity in Terms of Anti-PRP Antibody Concentrations.', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Antibody concentrations against PRP were determined and expressed as GMCs. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.'}, {'measure': 'Immunogenicity in Terms of Anti-HBs Antibody Concentrations.', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Antibody concentrations against Hepatitis B were determined and expressed as GMCs. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.'}, {'measure': 'Immunogenicity in Terms of Anti-poliovirus Types 1, 2 and 3 Antibody Titers.', 'timeFrame': 'At Month 5 (One month after Dose 3 of co-administered vaccines)', 'description': 'Antibody concentrations against Poliovirus types 1, 2 and 3 were determined and expressed as Geometric Mean Titers (GMTs).'}, {'measure': 'Number of Subjects With Any Solicited General Adverse Events (AEs).', 'timeFrame': 'During the 8-day (Days 1-8) follow-up period after each HRV vaccination.', 'description': 'Assessed solicited general AEs were cough/runny nose; diarrhoea; fever measured by 3 routes which were oral, axillary and rectal, defined as temperature ≥ 38.0 degrees Celsius (°C); irritability; loss of appetite and vomiting. Any = any solicited general AE irrespective of its intensity grade and relationship to vaccination'}, {'measure': 'Number of Subjects With Any Unsolicited AEs.', 'timeFrame': 'During the 31-day (Days 1-31) follow-up period after each HRV vaccination.', 'description': "Unsolicited AEs assessed include any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any= Any unsolicited AE irrespective of its intensity grade and relationship to vaccination."}, {'measure': 'Number of Subjects With Any Serious Adverse Events (SAEs).', 'timeFrame': 'During the entire study period (Day 1 to Month 10)', 'description': 'SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunogenicity', 'lyophilized formulation', 'United States', 'Reactogenicity', 'Safety', 'Porcine circovirus -free', 'Human rotavirus vaccine', 'liquid formulation', 'Healthy infants'], 'conditions': ['Rotavirus Infection', 'Rotavirus Vaccines']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess if there is any immune interference between the Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as compared to the currently licensed lyophilized formulation of the HRV vaccine when co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects' parent(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 (42-90 days) of age at the time of the first study vaccination.\n* Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.\n* Healthy subjects as established by medical history and clinical examination before entering into the study.\n\nExclusion Criteria:\n\n* Child in care.\n* Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day-29 to Day 1), or planned use during the study period.\n* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone (≥0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.\n* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.\n* Administration of long-acting immune-modifying drugs at any time during the study period.\n* Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of vaccine administration and ending at Visit 4, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study, if administered at a site which is different from the sites used to administer the co-administered vaccines.\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.\n* Uncorrected congenital malformation of the gastrointestinal tract that would predispose for Intussusception (IS).\n* History of IS.\n* Very prematurely born infants (born ≤28 weeks of gestation).\n* Family history of congenital or hereditary immunodeficiency.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n* Major congenital defects or serious chronic illness.\n* Previous vaccination against Haemophilus type b (Hib), diphtheria, tetanus, pertussis, pneumococcus, RV and/or poliovirus.\n* Previous confirmed occurrence of RV GE, Hib, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B and/or polio disease.\n* Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.\n* GE within 7 days preceding the study vaccine administration.\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.\n* Hypersensitivity to latex.\n* History of any neurological disorders or seizures.\n* History of Severe combined immunodeficiency (SCID).\n* Acute disease and/or fever at the time of enrolment.\n\n * Fever is defined as temperature ≥38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity, the axilla and the rectum.\n * Subjects with a minor illness without fever may be enrolled at the discretion of the investigator."}, 'identificationModule': {'nctId': 'NCT03207750', 'briefTitle': "This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Immunogenicity, Reactogenicity and Safety Study of Pediarix®, Hiberix® and Prevenar 13® Co-administered With Two Different Formulations of GSK Biologicals' HRV Vaccine (444563) in Healthy Infants 6-12 Weeks of Age", 'orgStudyIdInfo': {'id': '201663'}, 'secondaryIdInfos': [{'id': '2016-003210-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HRV PCV-free Liq Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.', 'interventionNames': ['Biological: Rotarix', 'Biological: Pediarix', 'Biological: Hiberix', 'Biological: Prevenar 13']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HRV Lyo Group', 'description': 'Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).', 'interventionNames': ['Biological: Rotarix', 'Biological: Pediarix', 'Biological: Hiberix', 'Biological: Prevenar 13']}], 'interventions': [{'name': 'Rotarix', 'type': 'BIOLOGICAL', 'otherNames': ["GSK Biologicals' PCV-free liquid formulation of oral live attenuated HRV vaccine.", "GSK Biologicals' lyophilized formulation of oral live attenuated HRV vaccine."], 'description': 'Two doses administered orally according to a 0, 2 month schedule as per the immunization schedule for HRV vaccine administration in the US.', 'armGroupLabels': ['HRV Lyo Group', 'HRV PCV-free Liq Group']}, {'name': 'Pediarix', 'type': 'BIOLOGICAL', 'otherNames': ["GSK Biologicals' Diphtheria and tetanus toxoids and acellular pertussis adsorbed", 'hepatitis B (recombinant) and inactivated poliovirus vaccine.'], 'description': 'Three doses administered intramuscularly according to a 0, 2, 4 month schedule.', 'armGroupLabels': ['HRV Lyo Group', 'HRV PCV-free Liq Group']}, {'name': 'Hiberix', 'type': 'BIOLOGICAL', 'otherNames': ["GSK Biologicals' Haemophilus b conjugate vaccine (tetanus toxoid conjugate)"], 'description': 'Three doses administered intramuscularly according to a 0, 2, 4 month schedule.', 'armGroupLabels': ['HRV Lyo Group', 'HRV PCV-free Liq Group']}, {'name': 'Prevenar 13', 'type': 'BIOLOGICAL', 'otherNames': ["Pfizer's Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 Protein)"], 'description': 'Three doses administered intramuscularly according to a 0, 2, 4 month schedule.', 'armGroupLabels': ['HRV Lyo Group', 'HRV PCV-free Liq 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': '94015', 'city': 'Daly City', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.70577, 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'21702', 'city': 'Frederick', 'state': 'Maryland', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.41427, 'lon': -77.41054}}, {'zip': '02721', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '48025', 'city': 'Bingham Farms', 'state': 'Michigan', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.51587, 'lon': -83.27326}}, {'zip': '68504', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68505', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68522', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'GSK Investigational Site', 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'city': 'North Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.85462, 'lon': -79.97481}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '76107', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': '84037', 'city': 'Kaysville', 'state': 'Utah', 'country': 'United States', 'facility': 'GSK Investigational Site', 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'GSK Investigational Site', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}, {'zip': '84075', 'city': 'Syracuse', 'state': 'Utah', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.08939, 'lon': -112.06467}}, {'zip': '22902', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicalstudydatarequest.com/Posting.aspx?ID=20750', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)', 'ipdSharing': 'YES', 'description': 'IPD for this study is available via the Clinical Study Data Request site.', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}