Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT00169858
Status:
COMPLETED
Last Update Posted:
2013-05-29
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C075654', 'term': 'Engerix-B'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-24', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the persistence of antibodies to Engerix-B in all subjects at age 25 and to compare the levels obtained in those given a booster injection at age 15 or 20 with those receiving no booster injection.', 'timeFrame': '1995 - 2011', 'description': 'Long term persistence of anti-HBs and the effect of a booster dose given 5, 10 or 15 years post-primary vaccination.'}], 'secondaryOutcomes': [{'measure': '- To determine the antibody levels obtained following primary vaccination and the proportion of children who seroconvert', 'timeFrame': '1 month post primary vaccination', 'description': 'Anti-HBs titers were measured 1 months post-primary vaccination'}, {'measure': '- To determine the antibody levels of one third of subjects at age 15, 5 years after primary vaccination (Group A)', 'timeFrame': '2001', 'description': 'Anti-HBs titers were measured 5 years post primary vaccination.'}, {'measure': '- To determine the effect on antibody levels of a booster injection at age 15 years given to one third of the subjects (Group A)', 'timeFrame': '2001', 'description': 'The effect of a booster dose was measured'}, {'measure': '- To determine the antibody levels of subjects in groups A and B at age 20, 5 years after booster (Group A), 10 years after primary vaccination (Group B)', 'timeFrame': '2006', 'description': 'Anti-HBs titers were measured 10 years post primary vaccination (Group B) and 5 years post booster dose (Group A)'}, {'measure': '- To determine the effect on antibody levels of a booster injection at age 20 years given to one third of the subjects (Group B)', 'timeFrame': '2006', 'description': 'Anti-HBs titers were measured 1 month post booster dose given 10 years post-primary vaccination'}, {'measure': '- To determine the persistence of antibody 15 years after primary vaccination (Group C)', 'timeFrame': '2011', 'description': 'Anti-HBs titers will be measured'}, {'measure': '- To determine the antibody levels of subjects in Group A and Group B one year after their 5 or 10 year booster', 'timeFrame': '2011', 'description': 'anti-HBs titers will be measured 10 years post booster dose (Group A) and 5 years post booster dose (Group B)'}, {'measure': '- To evaluate the effect of a booster dose given 15 years post primary vaccination (Group C)', 'timeFrame': '2011', 'description': 'Anti-HBs titers will be measured one month post booster dose (Group C)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatitis B', 'Vaccination', 'Engerix-B', 'Immunogenicity', 'Long-term immunity', 'Booster dose', 'Safety'], 'conditions': ['Hepatitis B', 'Vaccination']}, 'referencesModule': {'references': [{'pmid': '15750456', 'type': 'RESULT', 'citation': 'Duval B, Gilca V, Boulianne N, De Wals P, Masse R, Trudeau G, De Serres G. Comparative long term immunogenicity of two recombinant hepatitis B vaccines and the effect of a booster dose given after five years in a low endemicity country. Pediatr Infect Dis J. 2005 Mar;24(3):213-8. doi: 10.1097/01.inf.0000154329.00361.39.'}, {'pmid': '10618544', 'type': 'RESULT', 'citation': 'Duval B, Boulianne N, De Serres G, Laflamme N, De Wals P, Masse R, Trudeau G, Delage G, Desjardins L. Comparative immunogenicity under field conditions of two recombinant hepatitis B vaccines in 8-10-year-old children. Vaccine. 2000 Feb 14;18(15):1467-72. doi: 10.1016/s0264-410x(99)00422-3.'}, {'pmid': '19683086', 'type': 'RESULT', 'citation': 'Gilca V, De Serres G, Boulianne N, De Wals P, Murphy D, Trudeau G, Masse R, Duval B. Antibody kinetics among 8-10 years old respondents to hepatitis B vaccination in a low endemic country and the effect of a booster dose given 5 or 10 years later. Vaccine. 2009 Oct 9;27(43):6048-53. doi: 10.1016/j.vaccine.2009.07.100. Epub 2009 Aug 13.'}, {'pmid': '23206974', 'type': 'RESULT', 'citation': 'Gilca V, De Serres G, Boulianne N, Murphy D, De Wals P, Ouakki M, Trudeau G, Masse R, Dionne M. Antibody persistence and the effect of a booster dose given 5, 10 or 15 years after vaccinating preadolescents with a recombinant hepatitis B vaccine. Vaccine. 2013 Jan 7;31(3):448-51. doi: 10.1016/j.vaccine.2012.11.037. Epub 2012 Dec 1.'}]}, 'descriptionModule': {'briefSummary': 'Hepatitis B immunization has been offered to all grade 4 students (age 9-10) in the province of Quebec, using Engerix-B at a dose of 10 mkg. The peak incidence of hepatitis B occurs between age 15 and 35; the proportion of vaccinated children who will still be protected at this age is currently unknown. This study is designed to determine:\n\n* persistence of immunity until age 25\n* persistence of immunological memory as demonstrated by an anamnestic response following a booster dose\n* the effect of a booster dose on immunogenicity at either 5, 10 or 15 years after the primary vaccination course (at age (15, 20 or 25).', 'detailedDescription': 'Three doses of Engerix-B vaccine (10 mkg) were administered according to 0, 1, 6 month schedule to 1126 9-10 year-old children.\n\nThe primary objective of the study is to evaluate the persistence of antibodies to Engerix-B in all subjects at age 25 and to compare the levels obtained in those given a booster injection at age 15 or 20 with those receiving no booster injection.\n\nSecondary objectives\n\n* To determine the antibody levels obtained following primary vaccination and the proportion of children who seroconvert\n* To determine the antibody levels of one third of subjects at age 15, 5 years after primary vaccination (Group A)\n* To determine the effect on antibody levels of a booster injection at age 15 years given to one third of the subjects (Group A)\n* To determine the antibody levels of subjects in groups A and B at age 20, 5 years after booster (Group A), 10 years after primary vaccination (Group B)\n* To determine the effect on antibody levels of a booster injection at age 20 years given to one third of the subjects (Group B)\n* To determine the effect on antibody levels of a booster injection at age 25 years given to one third of the subjects (Group C)\n* To determine the antibody levels of subjects in Group A and Group B one year after their 5 or 10 year booster\n* To evaluate safety'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Previously completed the 1995 to 1996 Hepatitis B vaccination program vaccinations (Primary study) to the best of his/her knowledge and already enrolled and followed in the long term study\n* Must be HBc negative\n* Required standard interval between last dose of primary immunization and booster vaccination\n* Written informed consent obtained from the subject\n* Free of obvious health problems as established by medical history and clinical examination before entering into the study\n* Previously completed routine childhood vaccination to the best of his/her knowledge\n* If the subject is female, and the potential of pregnancy exists, it must be asked prior to immunization by the study nurse. According to the protocol d'immunisation du Québec, Engerix-B is not contra-indicated during pregnancy. However, if a participant thinks she could be pregnant (sexually active and no oral contraception or intra uterine device), a pregnancy test will be carried out. In case of pregnancy, the booster vaccination will be performed after delivery.\n\nExclusion Criteria:\n\n\\- Not applicable"}, 'identificationModule': {'nctId': 'NCT00169858', 'briefTitle': 'Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Open Randomised Clinical Study of the Long Term Immunogenicity of Engerix-B in 10 Year Old Children and of the Effect of Booster Injections Given 5, 10 or 15 Years After Primary Vaccination', 'orgStudyIdInfo': {'id': 'HBV-257 ext. HBV-278'}, 'secondaryIdInfos': [{'id': '103860/257 ext. 278'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Engerix-B', 'type': 'BIOLOGICAL', 'description': '10 mkg per dose; 3 doses according to 0, 1, 6 month schedule; booster doses 5, 10 or 15 years post-primary vaccination.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1E 7G9', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Vladimir Gilca', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Bernard Duval, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laval University Hospital Center, Public Health Research Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National en Santé Publique du Québec', 'class': 'OTHER'}, {'name': 'Centre de Recheche du Centre Hospitalier Université Laval', 'class': 'OTHER'}, {'name': 'SmithKlinBeecham Biologicals', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Vladimir Gilca', 'investigatorAffiliation': 'Laval University'}}}}