Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-26 @ 6:52 AM
Study NCT ID:
NCT02094833
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2014-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}, {'id': 'D011051', 'term': 'Poliomyelitis'}, {'id': 'D006509', 'term': 'Hepatitis B'}], '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': 'D003015', 'term': 'Clostridium 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': 'D016871', 'term': 'Pasteurellaceae 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': 'D014777', 'term': 'Virus Diseases'}, {'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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017325', 'term': 'Hepatitis B Vaccines'}, {'id': 'C426945', 'term': 'Pentavac'}, {'id': 'C484909', 'term': 'Euvax-B'}], 'ancestors': [{'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2014-03-20', 'studyFirstSubmitQcDate': '2014-03-20', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 International Units (IU)/mL', 'timeFrame': '1 month post third vaccination', 'description': 'Anti-Diphtheria antibodies will be measured by a toxin neutralization test'}, {'measure': 'Number of participants with anti-Tetanus antibody concentrations ≥ 0.1 International unit (IU)/mL', 'timeFrame': '1 month post third vaccination', 'description': 'Anti-Tetanus antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Number of participants with ≥ 4 fold increase in anti-PT and anti-FHA antibody concentrations (EU/mL) from 1 month pre-dose 1 to 1 month post-dose 3', 'timeFrame': 'I month post dose 3', 'description': 'Anti-PT and anti-FHA antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).'}], 'secondaryOutcomes': [{'measure': 'Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 IU/mL and ≥ 0.1 IU/mL International Units (IU)/mL', 'timeFrame': 'Day 0 Pre-vaccination', 'description': 'Anti-Diphtheria antibodies will be measured by a toxin neutralization test'}, {'measure': 'Number of participants with anti-Hepatitis B antibody concentrations ≥ 10 mIU/mL international unit (IU)/mL', 'timeFrame': 'Day 0 Pre-vaccination', 'description': 'Anti-Hepatitis B antibodies will be measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System using chemiluminescence detection technology'}, {'measure': 'Number of participants with anti Diphtheria antibody concentrations ≥ 0.1 IU/mL International Units (IU)/mL', 'timeFrame': '1 month post third vaccination', 'description': 'Anti-Diphtheria antibodies will be measured by a toxin neutralization test'}, {'measure': 'Number of participants reporting solicited injection site and solicited systemic reactions, unsolicited adverse events, and serious adverse events following vaccination with either DTaP-IPV-Hep B-PRP~T combined vaccine or Pentaxim™ and Euvax B® vaccine', 'timeFrame': 'Day 0 and up to Day 180 post-vaccination', 'description': 'Solicited injection site reactions Tenderness, Erythema, and Swelling. Solicited systemic reactions Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite loss, and Irritability.'}, {'measure': 'Number of participants with response to vaccine Pertussis toxoid (PT) and Filamentous Haemagglutinin (FHA) antigens', 'timeFrame': '1 month post third vaccination', 'description': 'Vaccine response defined as: Post-dose 3 anti-PT and anti-FHA antibody concentrations in ELISA units (EU)/mL ≥ 4 x Lower Limit of Quantitation (LLOQ) if pre-vaccination concentration is \\< 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diphtheria', 'Tetanus', 'Pertussis', 'Haemophilus influenzae type b infection', 'Hepatitis B', 'DTaP-IPV-Hep - PRP-T vaccine'], 'conditions': ['Diphtheria', 'Tetanus', 'Pertussis', 'Haemophilus Influenzae Type b Infection', 'Poliomyelitis', 'Hepatitis B']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP\\~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's DTaP-IPV//PRP\\~T combined vaccine (Pentaxim™) given at 2, 4, and 6 months of age and Hep B vaccine (Euvax B®) given at 1 and 6 months of age in South Korean infants that received a birth dose of Hep B and born to mothers documented to be serum anti-HBs Ag negative.\n\nPrimary Objective\n\n* To demonstrate the non-inferiority in terms of seroprotection (Diphtheria, Tetanus, poliovirus types 1, 2, and 3, PRP-T, Hep B) and vaccine response for pertussis antigens (pertussis toxoid \\[PT\\] and filamentous haemagglutinin \\[FHA\\]) of Group A versus Group B, one month after the third dose of combined vaccines.\n\nSecondary Objectives:\n\n* To further study the immunogenicity of the two vaccination schemes, before the first dose and one month after the last dose of vaccines.\n* To study the safety after each and any dose of vaccines administered in the two vaccination schemes", 'detailedDescription': 'Study participants who received a first dose of recombinant Hep B vaccine at birth will receive either DTaP-IPV-Hep B-PRP\\~T combined vaccine at 2, 4, and 6 months of age + 3 doses of Hep B vaccine or Hep B vaccine (Euvax B®) at 1 and 6 months of age and DTaP IPV//PRP\\~T combined vaccine (Pentaxim™) at 2, 4, and 6 months of age, according to the official vaccination schedule for Hep B, DTaP, poliovirus, and Hib vaccinations in South Korea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '1 Month', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 30 to 40 days on the day of the first study visit\n* Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg\n* Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative\n* Participant and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures\n* Born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available)\n* Have received one documented dose of Hep B vaccine at birth according to the national recommendations.\n\nExclusion Criteria:\n\n* Participation in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure\n* Receipt of any vaccine in the 4 weeks preceding any trial vaccination (except Bacille Calmette Guerin (BCG) vaccine) or planned receipt of any vaccine in the 8 days following any trial vaccination\n* Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth) diseases or Haemophilus influenzae type b infection with either the trial vaccine or another vaccine\n* Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)\n* Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity\n* History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infection, confirmed either clinically, serologically, or microbiologically\n* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances\n* Known thrombocytopenia, as reported by the parent/legally acceptable representative\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination\n* In an emergency setting, or hospitalized involuntarily\n* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion\n* Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided\n* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study\n* History of seizures.'}, 'identificationModule': {'nctId': 'NCT02094833', 'briefTitle': 'DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': "Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP~T Combined Vaccine at 2, 4, and 6 Months of Age Versus Sanofi Pasteur's DTaP IPV//PRP~T Combined Vaccine at 2, 4, and 6 Months of Age + Hep B Vaccine at 1 and 6 Months of Age, in South Korean Infants Primed With Hep B at Birth", 'orgStudyIdInfo': {'id': 'A3L31'}, 'secondaryIdInfos': [{'id': 'U1111-1127-6896', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Participants will receive 3 injections of the study vaccine (DTaP-IPV-Hep B-PRP\\~T combined vaccine) at 2, 4, and 6 months of age', 'interventionNames': ['Biological: DTaP-IPV-Hep B-PRP~T combined vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Participants will receive 2 injections of monovalent Hep B vaccine (Euvax B®) at age 1 and 6 months and 3 injections of DTaP IPV//PRP\\~T vaccine (Pentaxim™) at age 2, 4, and 6 months', 'interventionNames': ['Biological: DTaP-IPV//PRP~T and Hepatitis B vaccine']}], 'interventions': [{'name': 'DTaP-IPV-Hep B-PRP~T combined vaccine', 'type': 'BIOLOGICAL', 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Group A']}, {'name': 'DTaP-IPV//PRP~T and Hepatitis B vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Pentaxim™', 'Euvax B®'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '301 724', 'city': 'Daejeon', 'country': 'South Korea', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '425 707', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '641 560', 'city': 'Gyeongsangnam Do', 'country': 'South Korea'}, {'city': 'Gyeongsangnam Do', 'country': 'South Korea'}, {'zip': '570 711', 'city': 'Jeollabuk Do', 'country': 'South Korea'}, {'zip': '561 712', 'city': 'Jeonbuk', 'country': 'South Korea'}, {'zip': '220 701', 'city': 'Kangwon Do', 'country': 'South Korea'}, {'zip': '420 717', 'city': 'Kyunggi Do', 'country': 'South Korea'}, {'zip': '120 752', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '130 87', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137 701', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '139 709', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '158 710', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '442 723', 'city': 'Suwon Gyeonggi Do', 'country': 'South Korea'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur SA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}