Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-03-04 @ 2:59 PM
Study NCT ID:
NCT01457508
Status:
COMPLETED
Last Update Posted:
2017-06-16
First Post:
2011-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately
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'}, {'id': 'C514867', 'term': 'Hiberix'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 440}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2000-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-15', 'studyFirstSubmitDate': '2011-10-20', 'studyFirstSubmitQcDate': '2011-10-20', 'lastUpdatePostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off value', 'timeFrame': 'One month after the 2nd dose of the primary vaccination course ( Month 3)'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity with respect to the components of the study vaccines in terms of number of seroprotected subjects', 'timeFrame': 'One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9)'}, {'measure': 'Immunogenicity with respect to the 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 ( Month 8 and 9)'}, {'measure': 'Immunogenicity with respect to the components of the study vaccines in terms of antibody titres', 'timeFrame': 'One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9)'}, {'measure': 'Immunogenicity with respect to the components of the study vaccines in terms of vaccine response', 'timeFrame': 'One month after the 3rd dose ( Month 9), and one month after the 2nd dose of the primary vaccination course ( Month3)'}, {'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 adverse events', 'timeFrame': 'Throughout the entire study up to and including 30 days post-vaccination ( Month 0 to Month 9)'}]}, 'conditionsModule': {'keywords': ['combination vaccine', 'DTPa-HBV-IPV', 'Hib'], 'conditions': ['Hepatitis B', 'Diphtheria', 'Haemophilus Influenzae Type b (Hib)', 'Poliomyelitis', 'Pertussis', 'Tetanus']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Crovari P. et al. Immunogenicity and reactogenicity of combined DTPa-HBV-IPV/Hib vaccine compared to concomitant administered DTPa-HBV-IPV and Hib vaccines given at 3, 5 and 11 months of age. Abstract presented at the 19th Annual Meeting ESPID, Istanbul, Turkey, 26-28 March 2001.'}, {'pmid': '15370670', 'type': 'BACKGROUND', 'citation': 'Gabutti G, Zepp F, Schuerman L, Dentico P, Bamfi F, Soncini R, Habermehl P, Knuf M, Crovari P; Cooperative Italian Group for the Study of Combined Vaccines. Evaluation of the immunogenicity and reactogenicity of a DTPa-HBV-IPV Combination vaccine co-administered with a Hib conjugate vaccine either as a single injection of a hexavalent combination or as two separate injections at 3, 5 and 11 months of age. Scand J Infect Dis. 2004;36(8):585-92. doi: 10.1080/00365540410017572.'}, {'pmid': '22349525', 'type': 'DERIVED', 'citation': 'Van Der Meeren O, Kuriyakose S, Kolhe D, Hardt K. Immunogenicity of Infanrix hexa administered at 3, 5 and 11 months of age. Vaccine. 2012 Apr 5;30(17):2710-4. doi: 10.1016/j.vaccine.2012.02.024. Epub 2012 Feb 18.'}]}, 'descriptionModule': {'briefSummary': "This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) 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 3 months 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\nThe following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study:\n\n* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.\n* Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination.\n* Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after.\n* Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.\n* History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.\n* History of allergic disease or reactions 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* History of seizures or of any neurological disease at study entry.\n* Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period.\n* Acute disease at time of enrolment'}, 'identificationModule': {'nctId': 'NCT01457508', 'briefTitle': 'Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Vaccine Mixed With Hib Vaccine to Healthy Infants at 3, 5 and 11 Months of Age, Compared to Each Vaccine Administered Separately', 'orgStudyIdInfo': {'id': '217744/054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Subjects will receive one single injection of DTPa-HBV-IPV vaccine mixed with Hib vaccine.', 'interventionNames': ['Biological: DTPa-HBV-IPV/Hib (Infanrix hexa™)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Subjects will receive two separate injections of DTPa-HBV-IPV and Hib vaccine.', 'interventionNames': ['Biological: DTPa-HBV-IPV (Infanrix penta™)', 'Biological: Hib (Hiberix™)']}], 'interventions': [{'name': 'DTPa-HBV-IPV/Hib (Infanrix hexa™)', 'type': 'BIOLOGICAL', 'description': 'Three doses administered intramuscularly', 'armGroupLabels': ['Group A']}, {'name': 'DTPa-HBV-IPV (Infanrix penta™)', 'type': 'BIOLOGICAL', 'description': 'Three doses administered intramuscularly', 'armGroupLabels': ['Group B']}, {'name': 'Hib (Hiberix™)', 'type': 'BIOLOGICAL', 'description': 'Three doses administered intramuscularly', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}