Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-28 @ 6:24 PM
Study NCT ID:
NCT00877357
Status:
UNKNOWN
Last Update Posted:
2009-05-06
First Post:
2009-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine
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': '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': 'D016871', 'term': 'Pasteurellaceae Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-05-05', 'studyFirstSubmitDate': '2009-04-06', 'studyFirstSubmitQcDate': '2009-04-06', 'lastUpdatePostDateStruct': {'date': '2009-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Solicited and unsolicited local and systemic adverse events following vaccination', 'timeFrame': '4 Months'}], 'secondaryOutcomes': [{'measure': 'Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine', 'timeFrame': '12 Months'}, {'measure': 'Lot Consistency based on safety and Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine from each of the three lots', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vaccine', 'Prevention', 'Diphtheria', 'Tetanus', 'Pertussis', 'Hepatitis B', 'Haemophilus influenzae type b', 'Lot Consistency', 'Long Term Immunogenicity', 'Reactogenicity', 'Healthy infants'], 'conditions': ['Diphtheria', 'Tetanus', 'Pertussis', 'Hepatitis B', 'Haemophilus Influenzae Type B']}, 'descriptionModule': {'briefSummary': 'A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy children in the age group six to eight weeks\n* Born after a normal gestational period (36 - 42 weeks)\n* Mother's HBsAg (hepatitis B surface antigen) assured negative.\n* Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.\n\nExclusion Criteria:\n\n* Administration of immunoglobulin or any blood products since birth.\n* Use of any investigational, un-registered drug, or vaccine other than the study vaccine (with the exception of oral polio vaccination OPV \\& BCG vaccine) during the study period or within 30 days preceding the first dose of the study vaccine.\n* Previous vaccination or evidence of infection with DTP or Hib.\n* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics.\n* Major congenital or hereditary immunodeficiency.\n* Infants born to mothers known to be HIV positive.\n* Infants having evidence of disease or fever, history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a CNS disorder at the time of vaccination.\n* Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.40C, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures, encephalopathy and hypersensitivity reaction.\n* Parent/s or guardian of subject unable to maintain diary card"}, 'identificationModule': {'nctId': 'NCT00877357', 'briefTitle': 'Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shantha Biotechnics Limited'}, 'officialTitle': 'Open Label Multicentric Randomized Phase IV Post Marketing Safety, Immunogenicity and Lot-to-Lot Consistency Analysis of Shan 5 [DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine] in Indian Infants', 'orgStudyIdInfo': {'id': 'SBL/DTPwHBHib/WHOCON/2008/0100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shan 5 Lot No 1', 'interventionNames': ['Biological: Shan 5']}, {'type': 'EXPERIMENTAL', 'label': 'Shan 5 Lot No 2', 'interventionNames': ['Biological: Shan 5']}, {'type': 'EXPERIMENTAL', 'label': 'Shan 5 Lot No 3', 'interventionNames': ['Biological: Shan 5']}], 'interventions': [{'name': 'Shan 5', 'type': 'BIOLOGICAL', 'description': 'Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine', 'armGroupLabels': ['Shan 5 Lot No 1', 'Shan 5 Lot No 2', 'Shan 5 Lot No 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'state': 'Uttarakhand', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Madhu Gupta, MD', 'role': 'CONTACT', 'email': 'madhugupta21@gmail.com', 'phone': '+91-172-2755223'}, {'name': 'Madhu Gupta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'School of Public Health, Post Graduate Institute of Medical Education and Research'}], 'centralContacts': [{'name': 'Mandeep S Dhingra, MD', 'role': 'CONTACT', 'email': 'drmandeep@shanthabiotech.co.in', 'phone': '+91-40-66301000', 'phoneExt': '1801'}], 'overallOfficials': [{'name': 'Raman Rao, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shantha Biotechnics Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shantha Biotechnics Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'VP, Scientific and Medical Affairs', 'oldOrganization': 'Shantha Biotechnics Limited'}}}}