Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT01357720
Status:
COMPLETED
Last Update Posted:
2013-09-09
First Post:
2011-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@crucell.com', 'phone': '+41(0)319086111', 'title': 'Medical Affairs Director', 'organization': 'Crucell Switzerland AG'}, 'certainAgreement': {'otherDetails': 'Any material for public dissemination will be submitted to the Sponsor for review at least ninety (90) days prior to submission for publication, public dissemination, or review by a publication committee', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.', 'eventGroups': [{'id': 'EG000', 'title': 'Quinvaxem', 'description': 'Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem', 'otherNumAtRisk': 200, 'otherNumAffected': 180, 'seriousNumAtRisk': 200, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tritanrix Hib/HepB + Quinvaxem', 'description': 'Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem', 'otherNumAtRisk': 200, 'otherNumAffected': 180, 'seriousNumAtRisk': 200, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 293, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 338, 'numAffected': 157}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 138, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 145, 'numAffected': 82}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 87, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 73, 'numAffected': 54}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 133, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 137, 'numAffected': 95}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 55, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 69, 'numAffected': 54}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Viral encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Idiopathic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Seroprotection Rate: Anti-PRP Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quinvaxem', 'description': 'Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem'}, {'id': 'OG001', 'title': 'Tritanrix Hib/HepB + Quinvaxem', 'description': 'Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98.1', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98.1', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the third vaccination', 'description': 'Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Available observations at Visit 4'}, {'type': 'PRIMARY', 'title': 'Seroprotection Rate: Anti-hepatitis B Surface Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quinvaxem', 'description': 'Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem'}, {'id': 'OG001', 'title': 'Tritanrix Hib/HepB + Quinvaxem', 'description': 'Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem'}], 'classes': [{'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '90.9', 'upperLimit': '97.6'}, {'value': '97.4', 'groupId': 'OG001', 'lowerLimit': '94.1', 'upperLimit': '99.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the third vaccination', 'description': 'Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate)', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Available observations at Visit 4'}, {'type': 'PRIMARY', 'title': 'Seroprotection Rate: Anti-diphtheria Toxoid Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quinvaxem', 'description': 'Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem'}, {'id': 'OG001', 'title': 'Tritanrix Hib/HepB + Quinvaxem', 'description': 'Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem'}], 'classes': [{'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98.1', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the third vaccination', 'description': 'Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate)', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Available observations at Visit 4'}, {'type': 'PRIMARY', 'title': 'Seroprotection Rate: Anti-tetanus Toxoid Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quinvaxem', 'description': 'Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem'}, {'id': 'OG001', 'title': 'Tritanrix Hib/HepB + Quinvaxem', 'description': 'Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98.2', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98.1', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the third vaccination', 'description': 'Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate)', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Available observations at Visit 4'}, {'type': 'PRIMARY', 'title': 'Seroprotection Rate: Anti-B. Pertussis Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quinvaxem', 'description': 'Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem'}, {'id': 'OG001', 'title': 'Tritanrix Hib/HepB + Quinvaxem', 'description': 'Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem'}], 'classes': [{'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000', 'lowerLimit': '96.4', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98.1', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the third vaccination', 'description': 'Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate)', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Available observations at Visit 4'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Quinvaxem', 'description': 'Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem'}, {'id': 'FG001', 'title': 'Tritanrix Hib/HepB + Quinvaxem', 'description': 'Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '195'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Participants were recruited at two vaccination sites in the Philippines:\n\nFirst subject first visit (FSFV): 30 May 2011 Last subject last visit (LSLV): 30 September 2011'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Quinvaxem', 'description': 'Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem'}, {'id': 'BG001', 'title': 'Tritanrix Hib/HepB + Quinvaxem', 'description': 'Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '0.91', 'groupId': 'BG000'}, {'value': '6.7', 'spread': '0.86', 'groupId': 'BG001'}, {'value': '6.7', 'spread': '0.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-29', 'studyFirstSubmitDate': '2011-05-19', 'resultsFirstSubmitDate': '2013-03-27', 'studyFirstSubmitQcDate': '2011-05-20', 'lastUpdatePostDateStruct': {'date': '2013-09-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-27', 'studyFirstPostDateStruct': {'date': '2011-05-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroprotection Rate: Anti-PRP Antibodies', 'timeFrame': '1 month after the third vaccination', 'description': 'Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)'}, {'measure': 'Seroprotection Rate: Anti-hepatitis B Surface Antibodies', 'timeFrame': '1 month after the third vaccination', 'description': 'Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate)'}, {'measure': 'Seroprotection Rate: Anti-diphtheria Toxoid Antibodies', 'timeFrame': '1 month after the third vaccination', 'description': 'Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate)'}, {'measure': 'Seroprotection Rate: Anti-tetanus Toxoid Antibodies', 'timeFrame': '1 month after the third vaccination', 'description': 'Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate)'}, {'measure': 'Seroprotection Rate: Anti-B. Pertussis Antibodies', 'timeFrame': '1 month after the third vaccination', 'description': 'Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vaccination', 'Immunisation', 'Virus', 'Diphtheria', 'Pertussis', 'Tetanus', 'Hepatitis B', 'Haemophilus Influenzae', 'Immunity'], 'conditions': ['Diphtheria', 'Pertussis', 'Tetanus', 'Hepatitis B', 'Haemophilus Infections']}, 'referencesModule': {'references': [{'pmid': '24176498', 'type': 'DERIVED', 'citation': 'Capeding MR, Jica C, Macura-Biegun A, Rauscher M, Alberto E. Interchangeability of Quinvaxem during primary vaccination schedules: results from a phase IV, single-blind, randomized, controlled, single-center, non-inferiority study. Vaccine. 2014 Feb 7;32(7):888-94. doi: 10.1016/j.vaccine.2013.10.059. Epub 2013 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'This is a study to show that vaccination with 1 dose of Tritanrix HB+Hib followed by Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for all 3 doses, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) 1 month after completion of the 6-10-14 week vaccination course.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '64 Days', 'minimumAge': '42 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A male or female between, and including, 42 and 64 days of age at the time of the first vaccination\n* Written informed consent obtained from parents/legal guardian of the subject\n* Free of obvious health problems as established by medical history and/or clinical examination before entering the study\n* Hepatitis B vaccination at birth (within 48 hours) Available for all scheduled study visits\n\nExclusion Criteria:\n\n* Use of any investigational drug or any investigational vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up\n* Planned administration of a vaccine not foreseen by the study protocol\n* Known or suspected impairment of immune function, known Human immunodeficiency virus (HIV)-positivity, receiving immunosuppressive therapy, or having received systemic immunosuppressive therapy within 1 month prior to study entry (note: inhaled and topical steroids are allowed)\n* Administration of parenteral immunoglobulin preparation and/or blood products since birth\n* Previous vaccination against Haemophilus influenzae type b (Hib) and/or diphtheria, tetanus, pertussis (DTP)\n* History of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component or to products containing mercury compounds, such as sodium ethylmercuro-thiosalicylate\n* Significant acute infection\n* Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives\n* Participation in another clinical study'}, 'identificationModule': {'nctId': 'NCT01357720', 'briefTitle': 'Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination', 'organization': {'class': 'INDUSTRY', 'fullName': 'Crucell Holland BV'}, 'officialTitle': 'A Phase IV, Single-blind, Randomized, Controlled, Monocentric Study to Assess the Interchangeability of Quinvaxem (DTwP-HepB-Hib) as the 2nd and 3rd Dose After Initial Vaccination With Tritanrix HB+Hib (DTwP-HepB/Hib) With Respect to Safety and Immunogenicity in Healthy Infants at 6, 10 and 14 Weeks of Age', 'orgStudyIdInfo': {'id': 'QVX-V-A001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quinvaxem', 'interventionNames': ['Biological: Quinvaxem']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tritanrix Hib/HepB + Quinvaxem', 'interventionNames': ['Biological: Quinvaxem/Tritanrix']}], 'interventions': [{'name': 'Quinvaxem', 'type': 'BIOLOGICAL', 'description': 'A single dose (0.5 mL) of Quinvaxem contains:\n\ndiphtheria antitoxin (\\>= 30 IU), tetanus antitoxin (\\>= 60 IU), whole-cell inactive pertussis bacteria (\\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen\n\nOne dose of Quinvaxem given at Weeks 6, 10 and 14', 'armGroupLabels': ['Quinvaxem']}, {'name': 'Quinvaxem/Tritanrix', 'type': 'BIOLOGICAL', 'description': 'A single dose (0.5 mL) of Quinvaxem contains:\n\ndiphtheria antitoxin (\\>= 30 IU), tetanus antitoxin (\\>= 60 IU), inactive pertussis bacteria (\\>= 4 IU), 10 mcg Hib polysaccharide conjugate (approx. 25 mcg tetanus toxoid), 10 mcg Hepatitis B surface antigen\n\nOne dose of Quinvaxem given at Weeks 6, 10 and 14', 'armGroupLabels': ['Tritanrix Hib/HepB + Quinvaxem']}]}, 'contactsLocationsModule': {'locations': [{'city': 'City of Muntinlupa', 'country': 'Philippines', 'facility': 'Research Institute for Tropical Medicine', 'geoPoint': {'lat': 14.39028, 'lon': 121.0475}}], 'overallOfficials': [{'name': 'Maria RZ Capeding, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Institute for Tropical Medicine (RITM)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Crucell Holland BV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}