Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:57 PM
Study NCT ID:
NCT00953056
Status:
COMPLETED
Last Update Posted:
2015-11-02
First Post:
2009-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China']}, 'interventionBrowseModule': {'meshes': [{'id': 'D022243', 'term': 'Rotavirus Vaccines'}, {'id': 'C492535', 'term': 'RotaTeq'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp and Dohme'}, 'certainAgreement': {'otherDetails': 'The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/ presentation. SPONSOR review can be expedited to meet publication guidelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': "One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ at the first and third dose but placebo at the second dose in error. The participant had moderate or mild diarrhea after the second and third doses, respectively. The participant's AE data is included in the AE tables under the Cohort III-RotaTeq™ treatment group.", 'eventGroups': [{'id': 'EG000', 'title': 'Cohort I - RotaTeq™, Adults', 'description': 'Adults randomized to receive a single dose of RotaTeq™.', 'otherNumAtRisk': 24, 'otherNumAffected': 6, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort I - Placebo, Adults', 'description': 'Adults randomized to receive a single dose of matching placebo to RotaTeq™.', 'otherNumAtRisk': 24, 'otherNumAffected': 2, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort II - RotaTeq™, Children', 'description': 'Children randomized to receive a single dose of RotaTeq™.', 'otherNumAtRisk': 24, 'otherNumAffected': 6, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort II - Placebo, Children', 'description': 'Children randomized to receive a single dose of matching placebo to RotaTeq™.', 'otherNumAtRisk': 24, 'otherNumAffected': 3, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort III - RotaTeq™, Infants', 'description': 'Infants randomized to receive 3 doses of RotaTeq™.', 'otherNumAtRisk': 24, 'otherNumAffected': 18, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort III - Placebo, Infants', 'description': 'Infants randomized to receive 3 doses of matching placebo to RotaTeq™.', 'otherNumAtRisk': 24, 'otherNumAffected': 14, 'seriousNumAtRisk': 24, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 23, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 19, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 22, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 25, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MALAISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BRONCHOPNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ENCEPHALITIS VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I - RotaTeq™, Adults', 'description': 'Adults randomized to receive a single dose of RotaTeq™.'}, {'id': 'OG001', 'title': 'Cohort I - Placebo, Adults', 'description': 'Adults randomized to receive a single dose of matching placebo to RotaTeq™.'}, {'id': 'OG002', 'title': 'Cohort II - RotaTeq™, Children', 'description': 'Children randomized to receive a single dose of RotaTeq™.'}, {'id': 'OG003', 'title': 'Cohort II - Placebo, Children', 'description': 'Children randomized to receive a single dose of matching placebo to RotaTeq™.'}, {'id': 'OG004', 'title': 'Cohort III - RotaTeq™, Infants', 'description': 'Infants randomized to receive 3 doses of RotaTeq™.'}, {'id': 'OG005', 'title': 'Cohort III - Placebo, Infants', 'description': 'Infants randomized to receive 3 doses of matching placebo to RotaTeq™.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 14 days post vaccination', 'description': 'All serious adverse events (SAEs) were collected for 14 days following each dose to obtain the number of participants with serious adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I - RotaTeq™, Adults', 'description': 'Adults randomized to receive a single dose of RotaTeq™.'}, {'id': 'OG001', 'title': 'Cohort I - Placebo, Adults', 'description': 'Adults randomized to receive a single dose of matching placebo to RotaTeq™.'}, {'id': 'OG002', 'title': 'Cohort II - RotaTeq™, Children', 'description': 'Children randomized to receive a single dose of RotaTeq™.'}, {'id': 'OG003', 'title': 'Cohort II - Placebo, Children', 'description': 'Children randomized to receive a single dose of matching placebo to RotaTeq™.'}, {'id': 'OG004', 'title': 'Cohort III - RotaTeq™, Infants', 'description': 'Infants randomized to receive 3 doses of RotaTeq™.'}, {'id': 'OG005', 'title': 'Cohort III - Placebo, Infants', 'description': 'Infants randomized to receive 3 doses of matching placebo to RotaTeq™.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 days post vaccination', 'description': 'The total number of serious adverse experiences (events) in participants up to 14 days post vaccination.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Infants With Fecal Vaccine Virus Shedding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort III - RotaTeq™, Infants', 'description': 'Infants randomized to receive 3 doses of RotaTeq™.'}, {'id': 'OG001', 'title': 'Cohort III - Placebo, Infants', 'description': 'Infants randomized to receive 3 doses of matching placebo to RotaTeq™.'}], 'classes': [{'title': 'Postdose 1 (n=23 for RotaTeq™, n=24 for placebo)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Postdose 2 (n=21 for RotaTeq™, n=22 for placebo)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Postdose 3 (n=22 for RotaTeq™, n=20 for placebo)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placebo', 'description': 'Fecal shedding of vaccine rotavirus in Cohort III (infants) was evaluated by determining the number of participants whose stool was positive by both (1) the Enzyme-linked Immunosorbent Assay (EIA) to detect the rotavirus antigen, and (2) PCR VP6 Genotyping (a polymerase chain reaction assay specific for rotavirus genome 6, coding for the VP6 protein of the vaccine virus). For analysis, two stool samples were collected per participant on separate days between Day 3 and Day 7 following each vaccination dose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants in Cohort III, infants that received the scheduled dose of vaccination, and for whom the stool samples were available for testing, were included in the analysis for that dose.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort I - RotaTeq™, Adults', 'description': 'Adults randomized to receive a single dose of RotaTeq™.'}, {'id': 'FG001', 'title': 'Cohort I - Placebo, Adults', 'description': 'Adults randomized to receive a single dose of matching placebo to RotaTeq™.'}, {'id': 'FG002', 'title': 'Cohort II - RotaTeq™, Children', 'description': 'Children randomized to receive a single dose of RotaTeq™.'}, {'id': 'FG003', 'title': 'Cohort II - Placebo, Children', 'description': 'Children randomized to receive a single dose of matching placebo to RotaTeq™.'}, {'id': 'FG004', 'title': 'Cohort III - RotaTeq™, Infants', 'description': 'Infants randomized to receive 3 doses of RotaTeq™.'}, {'id': 'FG005', 'title': 'Cohort III - Placebo, Infants', 'description': 'Infants randomized to receive 3 doses of matching placebo to RotaTeq™.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '24'}, {'groupId': 'FG005', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'comment': 'One participant received placebo at the second dose in error, but completed the study.', 'groupId': 'FG004', 'numSubjects': '22'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 144 participants were enrolled; 48 in each of 3 cohorts. This study was conducted sequentially in the 3 different Cohorts, Chinese adults (Cohort I) first, followed by children (Cohort II), and then infants (Cohort III).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '144', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort I - RotaTeq™, Adults', 'description': 'Adults randomized to receive a single dose of RotaTeq™.'}, {'id': 'BG001', 'title': 'Cohort I - Placebo, Adults', 'description': 'Adults randomized to receive a single dose of matching placebo to RotaTeq™.'}, {'id': 'BG002', 'title': 'Cohort II - RotaTeq™, Children', 'description': 'Children randomized to receive a single dose of RotaTeq™.'}, {'id': 'BG003', 'title': 'Cohort II - Placebo, Children', 'description': 'Children randomized to receive a single dose of matching placebo to RotaTeq™.'}, {'id': 'BG004', 'title': 'Cohort III - RotaTeq™, Infants', 'description': 'Infants randomized to receive 3 doses of RotaTeq™.'}, {'id': 'BG005', 'title': 'Cohort III - Placebo, Infants', 'description': 'Infants randomized to receive 3 doses of matching placebo to RotaTeq™.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '6 weeks to 12 weeks (infants)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}]}]}, {'title': '2 years to 5 years (children)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}]}]}, {'title': '19 years to 49 years (adults)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'description': 'The inclusion criterion for Cohort I (adults) in this study was 19-47 years. However, one participant who was 49 years at study entry was randomized.', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '70', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '74', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '144', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-30', 'studyFirstSubmitDate': '2009-08-04', 'resultsFirstSubmitDate': '2011-03-25', 'studyFirstSubmitQcDate': '2009-08-05', 'lastUpdatePostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-25', 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Serious Adverse Events', 'timeFrame': 'up to 14 days post vaccination', 'description': 'All serious adverse events (SAEs) were collected for 14 days following each dose to obtain the number of participants with serious adverse events.'}, {'measure': 'Number of Serious Adverse Events', 'timeFrame': '14 days post vaccination', 'description': 'The total number of serious adverse experiences (events) in participants up to 14 days post vaccination.'}], 'secondaryOutcomes': [{'measure': 'Number of Infants With Fecal Vaccine Virus Shedding', 'timeFrame': 'Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placebo', 'description': 'Fecal shedding of vaccine rotavirus in Cohort III (infants) was evaluated by determining the number of participants whose stool was positive by both (1) the Enzyme-linked Immunosorbent Assay (EIA) to detect the rotavirus antigen, and (2) PCR VP6 Genotyping (a polymerase chain reaction assay specific for rotavirus genome 6, coding for the VP6 protein of the vaccine virus). For analysis, two stool samples were collected per participant on separate days between Day 3 and Day 7 following each vaccination dose.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rotavirus Gastroenteritis']}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and tolerability of RotaTeq™ (V260) in the healthy Chinese populations. Approximately 144 participants will be enrolled and equally stratified into three age cohorts, Cohort I ages 19-47 years, Cohort II ages 2-6 years, and Cohort III ages 6-12 weeks. Randomization ratio is 1:1 in each cohort. The study will be conducted sequentially, participants in Cohort I then Cohort II receiving 1 dose of, and then participants in Cohort III receiving 3 doses of RotaTeq™/placebo. The primary investigator and the Ethics Review Committee will review blinded safety data and make decision based on their best clinical judgment to move study forward between cohorts. Duration for the entire study will be approximately 6-9 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '47 Years', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults ages 19 to 47 years for Cohort I\n* Healthy children ages 2 to 6 years for Cohort II\n* Healthy infants ages 6 to 12 weeks for Cohort III\n* Negative pregnancy test for females in Cohort I\n* Signed Informed Consent Forms (ICFs)\n\nExclusion Criteria:\n\n* Participants in Cohorts I and II receiving any vaccine 14 days before or anticipated after study vaccine\n* Participants in Cohort III receiving non-concomitant live vaccines 14 days before or after study vaccine\n* Prior administration of any rotavirus vaccine\n* Elevated temperature, with axillary temperature ≥37.1 Degrees C 24 hours before study vaccine\n* Prior or active gastrointestinal illnesses, immunodeficiency\n* Any condition which may interfere with evaluation of study objectives or make participation in the study unsafe for the participant'}, 'identificationModule': {'nctId': 'NCT00953056', 'briefTitle': 'A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled, Safety and Tolerability Study of Live Pentavalent Human-Bovine Reassortant Rotavirus Vaccine in Chinese Healthy Adults, Children and Infants', 'orgStudyIdInfo': {'id': 'V260-028'}, 'secondaryIdInfos': [{'id': '2009_627'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort I - RotaTeq™, Adults', 'description': 'Adults randomized to receive a single dose of RotaTeq™.', 'interventionNames': ['Biological: Rotavirus Vaccine, Live, Oral, Pentavalent']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort I - Placebo, Adults', 'description': 'Adults randomized to receive a single dose of matching placebo to RotaTeq™.', 'interventionNames': ['Biological: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort II - RotaTeq™, Children', 'description': 'Children randomized to receive a single dose of RotaTeq™.', 'interventionNames': ['Biological: Rotavirus Vaccine, Live, Oral, Pentavalent']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort II - Placebo, Children', 'description': 'Children randomized to receive a single dose of matching placebo to RotaTeq™.', 'interventionNames': ['Biological: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort III - RotaTeq™, Infants', 'description': 'Infants randomized to receive 3 doses of RotaTeq™.', 'interventionNames': ['Biological: Rotavirus Vaccine, Live, Oral, Pentavalent']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort III - Placebo, Infants', 'description': 'Infants randomized to receive 3 doses of matching placebo to RotaTeq™.', 'interventionNames': ['Biological: Comparator: Placebo']}], 'interventions': [{'name': 'Rotavirus Vaccine, Live, Oral, Pentavalent', 'type': 'BIOLOGICAL', 'otherNames': ['V260, RotaTeq™'], 'description': 'Single 2.0 mL dose V260 (RotaTeq™) administered orally at enrollment.\n\nThe 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses.', 'armGroupLabels': ['Cohort I - RotaTeq™, Adults', 'Cohort II - RotaTeq™, Children']}, {'name': 'Comparator: Placebo', 'type': 'BIOLOGICAL', 'description': 'Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.', 'armGroupLabels': ['Cohort I - Placebo, Adults', 'Cohort II - Placebo, Children']}, {'name': 'Rotavirus Vaccine, Live, Oral, Pentavalent', 'type': 'BIOLOGICAL', 'otherNames': ['V260, RotaTeq™.'], 'description': 'Three 2.0 mL doses of RotaTeq™ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.\n\nThe 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses.', 'armGroupLabels': ['Cohort III - RotaTeq™, Infants']}, {'name': 'Comparator: Placebo', 'type': 'BIOLOGICAL', 'description': 'Three 2.0 mL doses of matching placebo to RotaTeq™ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.', 'armGroupLabels': ['Cohort III - Placebo, Infants']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}