Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-02-21 @ 8:40 AM
Study NCT ID:
NCT01457495
Status:
COMPLETED
Last Update Posted:
2017-06-16
First Post:
2011-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}, {'id': 'D011051', 'term': 'Poliomyelitis'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D013742', 'term': 'Tetanus'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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': 'D016871', 'term': 'Pasteurellaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D003015', 'term': 'Clostridium Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541235', 'term': 'diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '1999-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-15', 'studyFirstSubmitDate': '2011-10-13', 'studyFirstSubmitQcDate': '2011-10-20', 'lastUpdatePostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with antibody titers equal to or greater than cut-off value.', 'timeFrame': 'One month after the 2nd dose of the primary vaccination course (month 3)'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity with respect to components of the study vaccines in terms of number of seropositive subjects', 'timeFrame': 'One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9)'}, {'measure': 'Immunogenicity with respect to components of the study vaccines in terms of antibody titers', 'timeFrame': 'One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9)'}, {'measure': 'Immunogenicity with respect to components of the study vaccines in terms of number of subjects with a vaccine response', 'timeFrame': 'One month after the 3rd dose of the primary vaccination course (Month 9)'}, {'measure': 'Occurrence of solicited local symptoms', 'timeFrame': 'Within 4 days after each vaccination and overall'}, {'measure': 'Occurrence of solicited general symptoms', 'timeFrame': 'Within 4 days after each vaccination and overall'}, {'measure': 'Occurrence of unsolicited symptoms', 'timeFrame': 'Within 30 days after each vaccination, and overall'}, {'measure': 'Occurrence of serious AEs', 'timeFrame': 'Throughout the entire study (approximately 9 months per subject) up to and including 30 days post-vaccination'}]}, 'conditionsModule': {'keywords': ['Infants', 'combined vaccine', 'DTPa-HBV-IPV/Hib', 'DTPa-IPV/Hib', 'safety', 'Immunogenicity', 'HBV'], 'conditions': ['Hepatitis B', 'Diphtheria', 'Haemophilus Influenzae Type b (Hib)', 'Poliomyelitis', 'Pertussis', 'Tetanus']}, 'descriptionModule': {'briefSummary': "This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 months of age."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Weeks', 'minimumAge': '12 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A male or female between 12 and 16 weeks of age at the time of the first vaccination.\n* Free of obvious health problems as established by medical history and clinical examination before entering into the study.\n* Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.\n* Administration of chronic immunosuppressants or immune-modifying drugs during the study period.\n* Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose and ending one month after each dose.\n* Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib diseases.\n* History of/or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.\n* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B.\n* Major congenital defects or serious chronic illness.\n* Progressive neurological disorders.\n* Administration of immunoglobulins and/or any blood products since birth and during the study period.\n* Acute febrile illness at the time of planned vaccination.'}, 'identificationModule': {'nctId': 'NCT01457495', 'briefTitle': 'Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Study to Assess Immunogenicity and Reactogenicity of SB Biologicals' DTPa-HBV-IPV/Hib Vaccine Given as Three-dose Primary Vaccination Course Compared to DTPa-IPV/Hib and HBV Administered Concomitantly at Separate Sites", 'orgStudyIdInfo': {'id': '217744/031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DTPa 1 Group', 'interventionNames': ['Biological: DTPa-HBV-IPV/Hib (Infanrix-hexa™)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DTPa 2 Group', 'interventionNames': ['Biological: DTPa-IPV/Hib (Infanrix-IPV/Hib™)', 'Biological: HBV (Engerix™-B)']}], 'interventions': [{'name': 'DTPa-HBV-IPV/Hib (Infanrix-hexa™)', 'type': 'BIOLOGICAL', 'description': '3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8', 'armGroupLabels': ['DTPa 1 Group']}, {'name': 'DTPa-IPV/Hib (Infanrix-IPV/Hib™)', 'type': 'BIOLOGICAL', 'description': '3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8', 'armGroupLabels': ['DTPa 2 Group']}, {'name': 'HBV (Engerix™-B)', 'type': 'BIOLOGICAL', 'description': '3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8', 'armGroupLabels': ['DTPa 2 Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}