Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT04073459
Status:
UNKNOWN
Last Update Posted:
2019-09-06
First Post:
2019-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy 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': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D011051', 'term': 'Poliomyelitis'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}], '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': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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': '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': 'D016871', 'term': 'Pasteurellaceae Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017778', 'term': 'Vaccines, Combined'}], 'ancestors': [{'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 336}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-03', 'studyFirstSubmitDate': '2019-08-27', 'studyFirstSubmitQcDate': '2019-08-27', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'seroprotection/seroconversion/vaccine-response rate', 'timeFrame': '4 weeks after three-dose primary series', 'description': 'Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components'}], 'secondaryOutcomes': [{'measure': 'Geometric mean concentration (GMC) or Geometric mean titer (GMT)', 'timeFrame': '4 weeks after three-dose primary series', 'description': 'GMC or GMT and their ratio of all types of antibodies'}, {'measure': 'Seroprotection rate against diphtheria with cut-off ≥ 1.0 IU/mL', 'timeFrame': '4 weeks after three-dose primary series', 'description': 'Proportion of subjects achieving anti-diphtheria toxoid antibody level with cut-off ≥ 1.0 IU/mL'}, {'measure': 'Seroprotection rate against tetanus with cut-off ≥ 1.0 IU/mL', 'timeFrame': '4 weeks after three-dose primary series', 'description': 'Proportion of subjects achieving anti-tetanus toxoid antibody level with cut-off ≥ 1.0 IU/mL'}, {'measure': 'Seroprotetion rate against PRP with cut-off ≥ 1 µg/mL', 'timeFrame': '4 weeks after three-dose primary series', 'description': 'Proportion of subjects achieving anti-PRP antibody level with cut-off ≥ 1 µg/mL'}, {'measure': 'Seroconversion rate against Salk serotypes', 'timeFrame': '4 weeks after three-dose primary series', 'description': 'Proportion of subjects achieving seroconversion of each Salk wild poliovirus serotype'}, {'measure': 'Seroprotection rate against Sabin and Salk serotypes', 'timeFrame': '4 weeks after three-dose primary series', 'description': 'Proportion of subjects achieving seroprotection of each Sabin and Salk poliovirus serotype'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diphtheria', 'Tetanus', 'Pertussis', 'Hepatitis B', 'Poliomyelitis', 'Haemophilus Influenzae Type b Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of EupentaTM Inj. and Imovax® Polio in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants and thereby to select the optimal dose of candidate vaccine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. A male or female healthy (i.e. free of obvious health problems) infant who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of first vaccination\n2. Born at full term pregnancy (Gestational age ≥ 37 weeks)\n3. Body weight ≥ 3.2 kg at the time of screening\n4. Received one dose of hepatitis B mono-vaccine within seven days of birth\n5. Born to both hepatitis B virus surface antigen (HBsAg) and human immunodeficiency virus (HIV) negative mother\n6. Subject's parent(s) or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures\n7. Written informed consent by subject's parent(s) or LAR\n\nExclusion Criteria:\n\n1. Previously received any dose of diphtheria, tetanus, pertussis, polio and/or Hib containing vaccines\n2. History of previous or concurrent vaccinations other than hepatitis B, Bacillus Calmette-Guerin (BCG), rotavirus and pneumococcal vaccine\n3. Known or suspected history of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, or Hib diseases\n4. Household contact and/or intimate exposure in the previous 30 days to an individual with ascertained diphtheria, pertussis, hepatitis B, polio or Hib diseases\n5. Experienced fever ≥ 38°C (100.4°F) within the past three days prior to screening\n6. Experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past seven days prior to screening\n7. Known or suspected immune disorder or immunodeficient condition\n8. Receipt of immunoglobulin or blood-derived product since birth\n9. Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, ≥0.5mg/kg/day. Inhaled and topical steroids are allowed.\n10. History of bleeding disorder contraindicating intramuscular injection\n11. Major congenital defects or serious chronic illness\n12. History of any neurological disorders or seizures\n13. History of allergic reactions to any vaccine components including excipients and preservatives (neomycin, streptomycin, polymyxin B, yeast or etc.)\n14. History of allergic reactions to latex\n15. Participation in another interventional trial or received any investigational product within 30 days before to the enrollment\n16. Plan to leave the area of the study site before the end of the study period\n17. Infants who are considered unsuitable for the clinical study by the investigator"}, 'identificationModule': {'nctId': 'NCT04073459', 'briefTitle': 'Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Chem'}, 'officialTitle': 'A Multi-center, Randomized, Active-controlled, Parallel-group, Open-label and Phase II Study to Evaluate Immunogenicity and Safety of LBVD (Fully Liquid Hexavalent Vaccine; Adsorbed Diphtheria-Tetanus-Pertussis-Hepatitis B- Inactivated Poliomyelitis (Sabin) and Haemophilus Influenzae Type b Conjugate Vaccine) Compared to Co-administration of EupentaTM Inj. and Imovax® Polio (Poliomyelitis Vaccine (Inactivated)) in Separate Injections in Healthy Infants at 6-10-14 Weeks of Age as Primary Series', 'orgStudyIdInfo': {'id': 'LG-VDCL002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L dose of Hexavalent', 'description': 'Low dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib)', 'interventionNames': ['Biological: DTwP-HepB-Sabin IPV-Hib']}, {'type': 'EXPERIMENTAL', 'label': 'M dose of Hexavalent', 'description': 'Middle dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib)', 'interventionNames': ['Biological: DTwP-HepB-Sabin IPV-Hib']}, {'type': 'EXPERIMENTAL', 'label': 'H dose of Hexavalent', 'description': 'High dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib).', 'interventionNames': ['Biological: DTwP-HepB-Sabin IPV-Hib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pentavalent+IPV', 'description': 'Co-administration of EupentaTM Inj and Imovax Polio', 'interventionNames': ['Biological: Pentavalent vaccine and Salk IPV']}], 'interventions': [{'name': 'DTwP-HepB-Sabin IPV-Hib', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection into the anterolateral area of the thigh', 'armGroupLabels': ['H dose of Hexavalent', 'L dose of Hexavalent', 'M dose of Hexavalent']}, {'name': 'Pentavalent vaccine and Salk IPV', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection into anterolateral area of the thigh', 'armGroupLabels': ['Pentavalent+IPV']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yunjeong Yang', 'role': 'CONTACT', 'email': 'yangyj@lgchem.com', 'phone': '+82-2-6987-4158'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Chem', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}