Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-27 @ 9:32 PM
Study NCT ID:
NCT06025695
Status:
COMPLETED
Last Update Posted:
2025-05-09
First Post:
2023-08-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005759', 'term': 'Gastroenteritis'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C492457', 'term': 'RIX4414 vaccine'}]}}, '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 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7.', 'description': 'SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.', 'eventGroups': [{'id': 'EG000', 'title': 'Human Rotavirus (HRV) Group', 'description': "Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.", 'otherNumAtRisk': 998, 'deathsNumAtRisk': 998, 'otherNumAffected': 596, 'seriousNumAtRisk': 998, 'deathsNumAffected': 1, 'seriousNumAffected': 251}, {'id': 'EG001', 'title': 'HRV Porcine Circovirus (PCV)-Free Group', 'description': "Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1.", 'otherNumAtRisk': 1002, 'deathsNumAtRisk': 1002, 'otherNumAffected': 617, 'seriousNumAtRisk': 1002, 'deathsNumAffected': 0, 'seriousNumAffected': 262}], 'otherEvents': [{'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 203, 'numAffected': 181}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 255, 'numAffected': 219}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 48, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 55, 'numAffected': 45}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dacryocystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dermatitis infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Eczema infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Exanthema subitum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Herpangina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Mycoplasma infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Chlamydial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Conjunctivitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Enterobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hand-foot-and-mouth disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 133, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 131, 'numAffected': 118}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 98, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 106, 'numAffected': 95}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Infantile diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Functional gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gingival cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Infantile colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dyschezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Mucous stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 96, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 94, 'numAffected': 87}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 62, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 86, 'numAffected': 81}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Nasal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 39, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 26, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 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'MedDRA v26.0'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pneumonia moraxella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pneumonia streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Infantile diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Functional gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Incarcerated inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Coordination abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Congenital megacolon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Craniosynostosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Vascular malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Immune thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Lymphangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 998, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Anti-rotavirus (RV) Immunoglobulin A (IgA) Antibody (Ab) Seroconversion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '865', 'groupId': 'OG000'}, {'value': '870', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Rotavirus (HRV) Group', 'description': "Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1."}, {'id': 'OG001', 'title': 'HRV Porcine Circovirus (PCV)-Free Group', 'description': "Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1."}], 'classes': [{'categories': [{'measurements': [{'value': '88.7', 'groupId': 'OG000', 'lowerLimit': '86.4', 'upperLimit': '90.7'}, {'value': '84.9', 'groupId': 'OG001', 'lowerLimit': '82.4', 'upperLimit': '87.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in seroconversion rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.73', 'ciLowerLimit': '-6.93', 'ciUpperLimit': '-0.55', 'estimateComment': 'The asymptotic standardized 95% CI for the difference in seroconversion rate between HRV PCV-free Group minus HRV Group is computed using the method of Miettinen and Nurminen.', 'groupDescription': 'To demonstrate the immunological non-inferiority of HRV PCV-free Group as compared to HRV Group in terms of seroconversion rates 1 month post-Dose 2.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority (NI) was to be demonstrated if the lower limit (LL) of the two-sided asymptotic standardized 95% confidence interval (CI) for the difference in seroconversion rate between the HRV PCV-free group and HRV group is greater than or equal to -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 2 (1-month post-Dose 2)', 'description': 'Seroconversion rate is defined as the percentage of participants who were initially seronegative (i.e., with anti-RV IgA Ab concentration below \\[\\<\\] 20 unit per milliliter \\[U/mL\\] prior the first dose of study intervention) and developed anti-RV IgA Ab concentration greater than or equal to (\\>=) 20 U/mL at Month 2 (1-month post-Dose 2).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Per Protocol Set (PPS), which includes all participants who adhered to the study protocol, ensuring they received no unapproved treatments, remained blinded, had anti-RV concentration \\<20 U/mL before intervention, had available anti-RV results at Month 2, complied with blood sampling schedules, and had no concurrent infections. Only participants with data available at specified timepoints were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '865', 'groupId': 'OG000'}, {'value': '870', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Rotavirus (HRV) Group', 'description': "Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1."}, {'id': 'OG001', 'title': 'HRV Porcine Circovirus (PCV)-Free Group', 'description': "Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1."}], 'classes': [{'categories': [{'measurements': [{'value': '222.82', 'groupId': 'OG000', 'lowerLimit': '198.03', 'upperLimit': '250.71'}, {'value': '157.31', 'groupId': 'OG001', 'lowerLimit': '139.31', 'upperLimit': '177.64'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.84', 'estimateComment': 'The comparison is done using the group GMC ratio (HRV PCV-free/HRV) (ANOVA model applied to the log10-transformed titers). The ANOVA model included the group as a fixed effect.', 'groupDescription': 'To demonstrate the non-inferiority of the HRV PCV-free Group as compared to HRV Group in terms of serum anti-RV IgA Ab concentrations 1 month post-Dose 2.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'NI was to be demonstrated if the LL of the two-sided 95% CI for the ratio of anti-RV IgA Ab GMC between the HRV PCV-free group and HRV group is greater than or equal to 0.67.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 2 (1-month post-Dose 2)', 'unitOfMeasure': 'U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS. Only participants with data available at the specified timepoints were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serum Anti-RV IgA Ab Concentrations >= 90 U/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '865', 'groupId': 'OG000'}, {'value': '870', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Rotavirus (HRV) Group', 'description': "Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1."}, {'id': 'OG001', 'title': 'HRV Porcine Circovirus (PCV)-Free Group', 'description': "Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1."}], 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000', 'lowerLimit': '66.1', 'upperLimit': '72.3'}, {'value': '62.9', 'groupId': 'OG001', 'lowerLimit': '59.6', 'upperLimit': '66.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.37', 'ciLowerLimit': '-10.81', 'ciUpperLimit': '-1.92', 'estimateComment': 'The asymptotic standardized 95% CI for the difference in in the percentage between HRV PCV-free Group minus HRV Group is computed using the method of Miettinen and Nurminen.', 'groupDescription': 'To demonstrate the immunological non-inferiority of HRV PCV-free Group as compared to HRV Group in terms of percentage of participants with anti-RV IgA antibody concentrations \\>=90 U/mL 1 month post-Dose 2.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'NI was to be demonstrated if the LL of the two-sided asymptotic standardized 95% CI for the difference in the percentage between the HRV PCV-free group and HRV group is greater than or equal to -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 2 (1-month post-Dose 2)', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS. Only participants with data available at the specified timepoints were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Solicited Systemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '973', 'groupId': 'OG000'}, {'value': '986', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Rotavirus (HRV) Group', 'description': "Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1."}, {'id': 'OG001', 'title': 'HRV Porcine Circovirus (PCV)-Free Group', 'description': "Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1."}], 'classes': [{'title': 'Cough/Runny Nose, post vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '973', 'groupId': 'OG000'}, {'value': '986', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}]}, {'title': 'Cough/Runny Nose, post vaccination at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '956', 'groupId': 'OG000'}, {'value': '961', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea, post vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '973', 'groupId': 'OG000'}, {'value': '986', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea, post vaccination at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '956', 'groupId': 'OG000'}, {'value': '961', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Fever/Pyrexia, post vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '973', 'groupId': 'OG000'}, {'value': '986', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Fever/Pyrexia, post vaccination at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '956', 'groupId': 'OG000'}, {'value': '961', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': 'Irritability/Fussiness, post vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '973', 'groupId': 'OG000'}, {'value': '986', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}]}, {'title': 'Irritability/Fussiness, post vaccination at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '956', 'groupId': 'OG000'}, {'value': '961', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Loss of appetite, post vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '973', 'groupId': 'OG000'}, {'value': '986', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Loss of appetite, post vaccination at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '956', 'groupId': 'OG000'}, {'value': '961', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting, post vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '973', 'groupId': 'OG000'}, {'value': '986', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting, post vaccination at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '956', 'groupId': 'OG000'}, {'value': '961', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 14 days (the day of vaccination and 13 subsequent days) after each vaccination (occurring at Day 1 and Month 1)', 'description': 'Solicited systemic events include fever/pyrexia, diarrhoea, vomiting, irritability/fussiness, loss of appetite, cough/runny nose. Fever is defined as body temperature \\>= 37.5 degrees Celsius (°C) and the preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Exposed Set which includes all participants with at least 1 dose of the study intervention administered and with the solicited systemic events diary card data available after the corresponding vaccination for the specified timepoint. Only participants with data available at the specified timepoints were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '998', 'groupId': 'OG000'}, {'value': '1002', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Rotavirus (HRV) Group', 'description': "Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1."}, {'id': 'OG001', 'title': 'HRV Porcine Circovirus (PCV)-Free Group', 'description': "Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1."}], 'classes': [{'title': 'Post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '998', 'groupId': 'OG000'}, {'value': '1002', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}]}, {'title': 'Post-vaccination at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '965', 'groupId': 'OG000'}, {'value': '970', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 31 days (the day of vaccination and 30 subsequent days) after each vaccination (occurring at Day 1 and Month 1)', 'description': "Unsolicited AEs 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 is reported as an unsolicited adverse event. Any = occurrence the event regardless of intensity grade or relation to the study vaccination", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Exposed Set which includes all participants with at least 1 dose of the study intervention administered and for whom unsolicited AEs data were available after the corresponding vaccination for the specified timepoint. Only participants with data available at the specified timepoints were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '998', 'groupId': 'OG000'}, {'value': '1002', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Rotavirus (HRV) Group', 'description': "Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1."}, {'id': 'OG001', 'title': 'HRV Porcine Circovirus (PCV)-Free Group', 'description': "Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1."}], 'classes': [{'categories': [{'measurements': [{'value': '251', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 to Month 7', 'description': 'An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or in other situations that are considered serious as per medical or scientific judgment. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Exposed Set which includes all participants with at least 1 dose of the study intervention administered and for whom SAE data were available after the corresponding vaccination for the specified timepoint. Only participants with data available at the specified timepoints were included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Human Rotavirus (HRV) Group', 'description': "Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1."}, {'id': 'FG001', 'title': 'HRV Porcine Circovirus (PCV)-Free Group', 'description': "Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '998'}, {'groupId': 'FG001', 'numSubjects': '1002'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '956'}, {'groupId': 'FG001', 'numSubjects': '967'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Migrated / Moved from the Study Area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Adverse Event Requiring Expedited Report', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted in China.', 'preAssignmentDetails': 'One participant was randomized to the HRV group but was vaccinated in the HRV PCV-free group. Data for this participant was analyzed in the HRV PCV-free group for all analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '998', 'groupId': 'BG000'}, {'value': '1002', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Human Rotavirus (HRV) Group', 'description': "Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1."}, {'id': 'BG001', 'title': 'HRV Porcine Circovirus (PCV)-Free Group', 'description': "Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '10.2', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '10.1', 'spread': '2.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'WEEKS', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '455', 'groupId': 'BG000'}, {'value': '512', 'groupId': 'BG001'}, {'value': '967', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '543', 'groupId': 'BG000'}, {'value': '490', 'groupId': 'BG001'}, {'value': '1033', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'ASIAN - EAST ASIAN HERITAGE', 'categories': [{'measurements': [{'value': '998', 'groupId': 'BG000'}, {'value': '1002', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-18', 'size': 1490018, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-23T00:46', 'hasProtocol': True}, {'date': '2023-08-25', 'size': 1329571, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-23T00:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study will be conducted in an observer-blind manner.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2023-08-29', 'resultsFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-23', 'studyFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Anti-rotavirus (RV) Immunoglobulin A (IgA) Antibody (Ab) Seroconversion Rate', 'timeFrame': 'At Month 2 (1-month post-Dose 2)', 'description': 'Seroconversion rate is defined as the percentage of participants who were initially seronegative (i.e., with anti-RV IgA Ab concentration below \\[\\<\\] 20 unit per milliliter \\[U/mL\\] prior the first dose of study intervention) and developed anti-RV IgA Ab concentration greater than or equal to (\\>=) 20 U/mL at Month 2 (1-month post-Dose 2).'}, {'measure': 'Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs)', 'timeFrame': 'At Month 2 (1-month post-Dose 2)'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Serum Anti-RV IgA Ab Concentrations >= 90 U/mL', 'timeFrame': 'At Month 2 (1-month post-Dose 2)'}, {'measure': 'Number of Participants Reporting Solicited Systemic Events', 'timeFrame': 'Within 14 days (the day of vaccination and 13 subsequent days) after each vaccination (occurring at Day 1 and Month 1)', 'description': 'Solicited systemic events include fever/pyrexia, diarrhoea, vomiting, irritability/fussiness, loss of appetite, cough/runny nose. Fever is defined as body temperature \\>= 37.5 degrees Celsius (°C) and the preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.'}, {'measure': 'Number of Participants Reporting Unsolicited Adverse Events (AEs)', 'timeFrame': 'Within 31 days (the day of vaccination and 30 subsequent days) after each vaccination (occurring at Day 1 and Month 1)', 'description': "Unsolicited AEs 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 is reported as an unsolicited adverse event. Any = occurrence the event regardless of intensity grade or relation to the study vaccination"}, {'measure': 'Number of Participants Reporting Serious Adverse Events (SAEs)', 'timeFrame': 'From Day 1 to Month 7', 'description': 'An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or in other situations that are considered serious as per medical or scientific judgment. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rotavirus (RV)', 'Human rotavirus (HRV)', 'Rotarix Porcine circovirus (PCV)-free liquid', 'Rotarix liquid', 'Healthy Chinese infants', 'Immunogenicity', 'Reactogenicity', 'Safety'], 'conditions': ['Gastroenteritis']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of the Porcine circovirus (PCV)-free liquid formulation of GlaxoSmithKline Biologicals' SA (GSK) oral live attenuated human rotavirus (HRV) study intervention compared to GSK's liquid oral live attenuated HRV study intervention in healthy Chinese infants 6 to 16 weeks of age at the time of the first study intervention administration."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants' parent(s)/legally acceptable representative(s) \\[LAR(s)\\], who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n* Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.\n* A male or female with Chinese origin, between, and including, 6 and 16 weeks (42-112 days) of age at the time of the first study intervention administration.\n* Healthy participants as established by medical history and clinical examination before entering into the study.\n* Born after a gestation period of 36 to 42 weeks inclusive.\n\nExclusion Criteria:\n\nMedical conditions\n\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).\n* History of severe combined immunodeficiency.\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.\n* History of seizures or progressive neurological disease.\n* Family history of congenital or hereditary immunodeficiency.\n* Uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception (IS).\n* History of IS.\n* Major congenital defects, or serious chronic illness as assessed by the investigator.\n* Previous confirmed occurrence of rotavirus gastroenteritis (RVGE).\n* Participants with confirmed or suspected Coronavirus Disease 2019 (COVID-19).\n\nPrior/Concomitant therapy\n\n* Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days before the first dose of study interventions (Day -29 to Day 1), or planned use during the study period.\n* Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the second dose of study intervention administration\\*, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations.\n\n \\*In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization programme, the time period described above can be reduced if, necessary for that mass vaccination vaccine, provided it is licensed and used according to its Product Information.\n* Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period.\n* Administration of long-acting immune-modifying drugs from birth or planned administration at any time during the study period.\n* Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone \\>= 0.5 milligram/kilogram (kg)/day, or equivalent. Inhaled and topical steroids are allowed.\n* Previous vaccination against RV.\n\nPrior/Concurrent clinical study experience\n\n\\- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.\n\nOther exclusions\n\n\\- Child in care."}, 'identificationModule': {'nctId': 'NCT06025695', 'briefTitle': "Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "A Phase III, Observer-blind, Randomized, Multicenter Study to Evaluate Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid as Compared to GSK's Rotarix Liquid, Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks", 'orgStudyIdInfo': {'id': '212692'}, 'secondaryIdInfos': [{'id': '2020-000972-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Human Rotavirus (HRV) Group', 'description': "Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.", 'interventionNames': ["Combination Product: GSK's liquid oral live attenuated HRV"]}, {'type': 'EXPERIMENTAL', 'label': 'HRV Porcine Circovirus (PCV)-free Group', 'description': "Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1.", 'interventionNames': ["Combination Product: PCV-free liquid formulation of GSK's oral live attenuated HRV"]}], 'interventions': [{'name': "GSK's liquid oral live attenuated HRV", 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Rotarix'], 'description': "2 doses of GSK's liquid oral live attenuated HRV study intervention administered orally at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China.", 'armGroupLabels': ['Human Rotavirus (HRV) Group']}, {'name': "PCV-free liquid formulation of GSK's oral live attenuated HRV", 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Rotarix PCV-free'], 'description': "2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention administered orally at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China.", 'armGroupLabels': ['HRV Porcine Circovirus (PCV)-free Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '678099', 'city': 'Baoshan', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.11626, 'lon': 99.16366}}, {'zip': '678199', 'city': 'Baoshan', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.11626, 'lon': 99.16366}}, {'zip': '678399', 'city': 'Baoshan', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.11626, 'lon': 99.16366}}, {'zip': '672499', 'city': 'Dali', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.58474, 'lon': 100.21229}}, {'zip': '652399', 'city': 'Honghe', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.40278, 'lon': 118.91806}}, {'zip': '610041', 'city': 'Mianyang', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.46784, 'lon': 104.68168}}, {'city': 'Mianyang', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.46784, 'lon': 104.68168}}, {'zip': '637300', 'city': 'Nanbu-Nanchong', 'country': 'China', 'facility': 'GSK Investigational Site'}, {'zip': '641200', 'city': 'Neijiang', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.58354, 'lon': 105.06216}}, {'zip': '679100', 'city': 'Tengchong', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 22.95379, 'lon': 113.00701}}, {'zip': '650034', 'city': 'Wenshan', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.7298, 'lon': 105.606}}, {'zip': '663300', 'city': 'Wenshan', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.7298, 'lon': 105.606}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.', 'ipdSharing': 'YES', 'description': 'IPD for this study will be made 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'}}}}