Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-01-01 @ 4:41 PM
Study NCT ID:
NCT00130832
Status:
COMPLETED
Last Update Posted:
2015-04-01
First Post:
2005-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Costa Rica', 'Guatemala', 'Mexico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012400', 'term': 'Rotavirus Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}], 'ancestors': [{'id': 'D012088', 'term': 'Reoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022243', 'term': 'Rotavirus Vaccines'}, {'id': 'D011055', 'term': 'Poliovirus Vaccine, Oral'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D023321', 'term': 'Poliovirus Vaccines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck 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': 'Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination.', 'description': 'The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment.\n\nAlthough a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.', 'eventGroups': [{'id': 'EG000', 'title': 'RotaTeq and Oral Poliovirus (OPV) Concomitantly', 'description': 'Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart', 'otherNumAtRisk': 366, 'otherNumAffected': 342, 'seriousNumAtRisk': 366, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'RotaTeq and Oral Poliovirus (OPV) Staggered', 'description': 'Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later', 'otherNumAtRisk': 359, 'otherNumAffected': 325, 'seriousNumAtRisk': 359, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 195}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 185}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Infantile colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 121}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 203}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 202}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 86}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 52}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'seriousEvents': [{'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Meningitis pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pertussis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq and Oral Poliovirus (OPV) Concomitantly', 'description': 'Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart'}, {'id': 'OG001', 'title': 'RotaTeq and Oral Poliovirus (OPV) Staggered', 'description': 'Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later'}], 'classes': [{'title': 'Antibody Responses to Poliovirus Type 1', 'categories': [{'measurements': [{'value': '888.0', 'groupId': 'OG000', 'lowerLimit': '752.8', 'upperLimit': '1047'}, {'value': '1139', 'groupId': 'OG001', 'lowerLimit': '969.1', 'upperLimit': '1340'}]}]}, {'title': 'Antibody Responses to Poliovirus Type 2', 'categories': [{'measurements': [{'value': '814.9', 'groupId': 'OG000', 'lowerLimit': '720.7', 'upperLimit': '921.4'}, {'value': '814.5', 'groupId': 'OG001', 'lowerLimit': '707.4', 'upperLimit': '937.9'}]}]}, {'title': 'Antibody Responses to Poliovirus Type 3', 'categories': [{'measurements': [{'value': '233.6', 'groupId': 'OG000', 'lowerLimit': '201.9', 'upperLimit': '270.2'}, {'value': '269.2', 'groupId': 'OG001', 'lowerLimit': '230.6', 'upperLimit': '314.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Seroprotection Rate Difference', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '1.4', 'groupDescription': 'Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \\[NA\\] ≥1:8) for poliovirus type 1', 'statisticalMethod': "Miettinen and Nurminen's", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.", 'testedNonInferiority': True, 'nonInferiorityComment': 'non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \\[NA\\] ≥1:8 greater than -10%.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Seroprotection Rate Difference', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '1.6', 'groupDescription': 'Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \\[NA\\] ≥1:8) for poliovirus type 2', 'statisticalMethod': "Miettinen and Nurminen's", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.", 'testedNonInferiority': True, 'nonInferiorityComment': 'non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \\[NA\\] ≥1:8 greater than -10%.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Seroprotection Rate Difference', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '2.3', 'groupDescription': 'Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \\[NA\\] ≥1:8) for poliovirus type 3', 'statisticalMethod': "Miettinen and Nurminen's", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.", 'testedNonInferiority': True, 'nonInferiorityComment': 'non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \\[NA\\] ≥1:8 greater than -10%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Approximately 42 days Postdose 3', 'description': 'GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.', 'unitOfMeasure': 'Geometric Mean Titer (GMT)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary immunogenicity analyses were based on evaluable per-protocol subjects who received all scheduled doses, were not protocol violators, and had valid assay values.'}, {'type': 'PRIMARY', 'title': 'GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq and Oral Poliovirus (OPV) Concomitantly', 'description': 'Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart'}, {'id': 'OG001', 'title': 'RotaTeq and Oral Poliovirus (OPV) Staggered', 'description': 'Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later'}], 'classes': [{'categories': [{'measurements': [{'value': '154.9', 'groupId': 'OG000', 'lowerLimit': '126.4', 'upperLimit': '189.9'}, {'value': '292.7', 'groupId': 'OG001', 'lowerLimit': '248.6', 'upperLimit': '344.6'}]}]}], 'analyses': [{'pValue': '0.277', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.69', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANOVA model on log titer of serum anti-rotavirus IgA', 'testedNonInferiority': True, 'nonInferiorityComment': 'non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the GMT ratio (concomitant group over staggered group) greater than 0.50.'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Point Difference', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-8.0', 'ciUpperLimit': '-1.4', 'estimateComment': 'Percentage point difference (concomitant - staggered)', 'statisticalMethod': "Miettinen and Nurminen's", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method.", 'testedNonInferiority': True, 'nonInferiorityComment': 'non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve 3-fold rise in serum anti-rotavirus IgA greater than -10%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Approximately 42 days Postdose 3', 'description': 'GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered', 'unitOfMeasure': 'GMT', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population'}, {'type': 'PRIMARY', 'title': 'Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq and Oral Poliovirus (OPV) Concomitantly', 'description': 'Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart'}, {'id': 'OG001', 'title': 'RotaTeq and Oral Poliovirus (OPV) Staggered', 'description': 'Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later'}], 'classes': [{'title': 'SNA responses to rotavirus serotypes G1', 'categories': [{'measurements': [{'value': '125.8', 'groupId': 'OG000', 'lowerLimit': '106.7', 'upperLimit': '148.2'}, {'value': '182.6', 'groupId': 'OG001', 'lowerLimit': '158.2', 'upperLimit': '210.7'}]}]}, {'title': 'SNA responses to rotavirus serotypes G2', 'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000', 'lowerLimit': '22.9', 'upperLimit': '32.0'}, {'value': '30.0', 'groupId': 'OG001', 'lowerLimit': '25.9', 'upperLimit': '34.8'}]}]}, {'title': 'SNA responses to rotavirus serotypes G3', 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '24.32'}, {'value': '22.5', 'groupId': 'OG001', 'lowerLimit': '19.4', 'upperLimit': '26.0'}]}]}, {'title': 'SNA responses to rotavirus serotypes G4', 'categories': [{'measurements': [{'value': '58.5', 'groupId': 'OG000', 'lowerLimit': '50.2', 'upperLimit': '68.1'}, {'value': '74.5', 'groupId': 'OG001', 'lowerLimit': '64.3', 'upperLimit': '86.3'}]}]}, {'title': 'SNA responses to rotavirus serotypes P1A', 'categories': [{'measurements': [{'value': '84.7', 'groupId': 'OG000', 'lowerLimit': '71.97', 'upperLimit': '99.8'}, {'value': '131.4', 'groupId': 'OG001', 'lowerLimit': '112.6', 'upperLimit': '153.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Approximately 42 days Postdose 3', 'description': 'Rotavirus SNA response to serotypes G1, G2, G3, G4, and P1A measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.', 'unitOfMeasure': 'GMT', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population\n\nFor serotype G4 the RotaTeq and Oral Poliovirus (OPV) concomitantly group N = 350'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RotaTeq and Oral Poliovirus (OPV) Concomitantly', 'description': 'Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart'}, {'id': 'FG001', 'title': 'RotaTeq and Oral Poliovirus (OPV) Staggered', 'description': 'Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '372'}, {'groupId': 'FG001', 'numSubjects': '363'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Those who received all 3 doses of concomitant RotaTeq™/ OPV with blood draw \\~42 days postdose 3', 'groupId': 'FG000', 'numSubjects': '356'}, {'comment': 'Those who received all 3 doses; last 2 blood draws \\~42 days postdose 3 of RotaTeq™ and postdose OPV', 'groupId': 'FG001', 'numSubjects': '346'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Enrollment occurred at 9 study sites in Mexico, Costa Rica, Guatemala, and Brazil from 19-Oct-2005 (first subject in) to 06-Jan-2006 (last subject randomized).', 'preAssignmentDetails': 'Excluded from randomization were subjects with history of congenital abdominal disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease, chronic diarrhea, or failure to thrive, clinical evidence of active gastrointestinal illness and those with fever, a rectal temperature ≥38.1°C (≥100.5°F) at time of immunization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'BG000'}, {'value': '363', 'groupId': 'BG001'}, {'value': '735', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RotaTeq and Oral Poliovirus (OPV) Concomitantly', 'description': 'Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart'}, {'id': 'BG001', 'title': 'RotaTeq and Oral Poliovirus (OPV) Staggered', 'description': 'Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '5 Weeks of Age and Under', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': '6 to 12 Weeks of Age', 'categories': [{'measurements': [{'value': '364', 'groupId': 'BG000'}, {'value': '362', 'groupId': 'BG001'}, {'value': '726', 'groupId': 'BG002'}]}]}, {'title': 'Over 12 Weeks of Age', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '352', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic American', 'categories': [{'measurements': [{'value': '263', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '520', 'groupId': 'BG002'}]}]}, {'title': 'Multi-Racial', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 735}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-12', 'studyFirstSubmitDate': '2005-08-12', 'resultsFirstSubmitDate': '2009-08-07', 'studyFirstSubmitQcDate': '2005-08-12', 'lastUpdatePostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-08-17', 'studyFirstPostDateStruct': {'date': '2005-08-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3', 'timeFrame': 'Approximately 42 days Postdose 3', 'description': 'GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.'}, {'measure': 'GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)', 'timeFrame': 'Approximately 42 days Postdose 3', 'description': 'GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered'}, {'measure': 'Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered', 'timeFrame': 'Approximately 42 days Postdose 3', 'description': 'Rotavirus SNA response to serotypes G1, G2, G3, G4, and P1A measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.'}]}, 'conditionsModule': {'conditions': ['Rotavirus Infections', 'Gastroenteritis']}, 'referencesModule': {'references': [{'pmid': '18756184', 'type': 'RESULT', 'citation': 'Ciarlet M, Sani-Grosso R, Yuan G, Liu GF, Heaton PM, Gottesdiener KM, Arredondo JL, Schodel F. Concomitant use of the oral pentavalent human-bovine reassortant rotavirus vaccine and oral poliovirus vaccine. Pediatr Infect Dis J. 2008 Oct;27(10):874-80. doi: 10.1097/INF.0b013e3181782780.'}]}, 'descriptionModule': {'briefSummary': 'The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing the safety or immunogenicity of either vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants in good health\n\nExclusion Criteria:\n\n* Previous administration of any oral poliovirus vaccine (OPV) and rotavirus vaccine\n* Receipt of inactivated poliovirus vaccine (IPV) prior to the first dose of either study vaccine, or at any time during the course of the study\n* Any condition resulting in depressed immunity\n* Any allergy to any vaccine component as stated in the package circulars\n* Allergies to polymyxin B, neomycin or any other antibiotics\n* Receipt of intramuscular, oral, or intravenous corticosteroid treatment\n* History of congenital abdominal disorders, intussusception, or abdominal surgery; clinical evidence of active gastrointestinal illness\n* History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive\n* Prior receipt of a blood transfusion or blood products, including immunoglobulin\n* Fever, with a rectal temperature of ≥38.1°C (≥ 100.5°F) at the time of immunization\n* Infants residing in a household with an immunocompromised person'}, 'identificationModule': {'nctId': 'NCT00130832', 'briefTitle': 'Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Safety and Immunogenicity of Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants', 'orgStudyIdInfo': {'id': 'V260-014'}, 'secondaryIdInfos': [{'id': '2005_030'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'RotaTeq and OPV concomitantly', 'interventionNames': ['Biological: Rotavirus Vaccine, Live, Oral, Pentavalent', 'Biological: Comparator: Oral Poliovirus Vaccine (OPV)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'RotaTeq and OPV on staggered schedule', 'interventionNames': ['Biological: Rotavirus Vaccine, Live, Oral, Pentavalent', 'Biological: Comparator: Oral Poliovirus Vaccine (OPV) (staggered)']}], 'interventions': [{'name': 'Rotavirus Vaccine, Live, Oral, Pentavalent', 'type': 'BIOLOGICAL', 'description': 'Three doses of rotavirus vaccine, live, oral, pentavalent. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.', 'armGroupLabels': ['1', '2']}, {'name': 'Comparator: Oral Poliovirus Vaccine (OPV)', 'type': 'BIOLOGICAL', 'description': 'Three doses OPV. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.', 'armGroupLabels': ['1']}, {'name': 'Comparator: Oral Poliovirus Vaccine (OPV) (staggered)', 'type': 'BIOLOGICAL', 'description': 'Three doses OPV. Dose 1 was given 14 to 28 days post Dose 1 of RotaTeq, Dose 2 was given 14 to 28 days post Dose 2 of RotaTeq, and Dose 3 was given 14 to 28 days post Dose 3 of RotaTeq.', 'armGroupLabels': ['2']}]}, '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'}}}}