Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 2:23 PM
Study NCT ID:
NCT04294433
Status:
UNKNOWN
Last Update Posted:
2020-03-04
First Post:
2020-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity of 2 Versus 3 Doses of Combined Hepatitis B Vaccines in 2-18 Months Old Children
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': 'C541235', 'term': 'diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised 1:1 for 2 study groups. Non-randomised for comparator group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2020-01-29', 'studyFirstSubmitQcDate': '2020-03-02', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunogenicity', 'timeFrame': '1 month post last dose of vaccine', 'description': 'The proportion of children with an anti-HBs titer ≥10mIU/ml'}], 'secondaryOutcomes': [{'measure': 'Immune memory', 'timeFrame': '36 months post last primary vaccine dose', 'description': 'Immune response to a booster dose'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaccination', 'Two doses', 'Infants'], 'conditions': ['Hepatitis B']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to compare the immunogenicity of the hepatitis B component in children vaccinated with (I) two doses of Infanrix-hexa administered at 2 and 12 months of age versus (II) one dose of Infanrix-hexa and one dose of Twinrix administered respectively at 2 and 12 months of age versus (III) three doses of Infanrix-hexa administered at 2, 4 and 18 months of age (comparator).', 'detailedDescription': 'In the province of Quebec, Canada, hepatitis B vaccination of infants involves three doses of vaccine, 2, 4 and 18 months of age. However, in the current epidemiological context (virtual absence of new cases in young Quebecers) and taking into account scientific data which consistently show a high immunogenicity and efficacy of two doses of hepatitis B vaccine, the relevance of the second dose given at the age of 4 months is questionable.\n\nthis study is designed to compare the immunogenicity of the hepatitis B component in children vaccinated with (I) two doses of Infanrix-hexa administered at 2 and 12 months of age versus (II) one dose of Infanrix-hexa and one dose of Twinrix administered respectively at 2 and 12 months of age versus (III) three doses of Infanrix-hexa administered at 2, 4 and 18 months of age (comparator).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '19 Months', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Comparator group :\n* have received 3 doses of Infanrix-hexa as part of the regular vaccination program at the age of 2, 4 and 18 months.\n\n • Study groups:\n* have received 1 dose of Infanrix-hexa as part of the regular vaccination program at the age of 2 months.\n\nExclusion Criteria:\n\n* Have received other doses of hepatitis B vaccine;\n\n * Be considered immunosuppressed;\n * Have an autoimmune disease;\n * Have contraindications to HBV vaccination, as defined in the Quebec Immunization Protocol;\n * Have a bleeding disorder;\n * Be significantly delayed in development;\n * Have or plan to participate in other clinical studies with vaccines or products not approved in Canada;\n * Have presented a serious clinical condition to the vaccines administered as part of the study.'}, 'identificationModule': {'nctId': 'NCT04294433', 'briefTitle': 'Immunogenicity of 2 Versus 3 Doses of Combined Hepatitis B Vaccines in 2-18 Months Old Children', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Clinical Trial to Assess Immunogenicity of 2 Versus 3 Doses of Hepatitis B Vaccines When Administered to Children Aged 2 to 18 Months', 'orgStudyIdInfo': {'id': 'Study 11022017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Infanrix-hexa+Infanrix-hexa+Infanrix-hexa', 'description': 'Children vaccinated at the age of 2, 4 and 18 months with a standard dose of Infanrix-hexa', 'interventionNames': ['Biological: Infanrix-hexa, Twinrix-Junior']}, {'type': 'EXPERIMENTAL', 'label': 'Infanrix-hexa+Infanrix-hexa', 'description': 'Children vaccinated at the age of 2 and 18 months with a standard dose of Infanrix-hexa', 'interventionNames': ['Biological: Infanrix-hexa, Twinrix-Junior']}, {'type': 'EXPERIMENTAL', 'label': 'Infanrix-hexa+Twinrix', 'description': 'Children vaccinated at the age of 2 and 18 months with a standard dose of Infanrix-hexa and a standard dose of Infanrix-Junior, respectively', 'interventionNames': ['Biological: Infanrix-hexa, Twinrix-Junior']}], 'interventions': [{'name': 'Infanrix-hexa, Twinrix-Junior', 'type': 'BIOLOGICAL', 'description': "Vaccines administrated according to product monographs' recommendations", 'armGroupLabels': ['Infanrix-hexa+Infanrix-hexa', 'Infanrix-hexa+Infanrix-hexa+Infanrix-hexa', 'Infanrix-hexa+Twinrix']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1E7G9', 'city': 'Québec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Vladimir Gilca, MD, PhD', 'role': 'CONTACT', 'email': 'vladimir.gilca@inspq.qc.ca', 'phone': '4186667000', 'phoneExt': '510'}, {'name': 'Chantal Sauvageau, MD, MSc', 'role': 'CONTACT', 'email': 'chantal.sauvageau@inspq.qc.ca', 'phone': '4186667000', 'phoneExt': '368'}, {'name': 'Vladimir Gilca, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Laval University Research Hospital Center', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G1E7G9', 'city': 'Québec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Vladimir Gilca, MD, PhD', 'role': 'CONTACT', 'email': 'vladimir.gilca@inspq.qc.ca', 'phone': '418 666 7000', 'phoneExt': '510'}, {'name': 'France Bouchard, RN', 'role': 'CONTACT', 'email': 'france.bouchard@ssss.gouv.qc.ca', 'phone': '418 666 7000', 'phoneExt': '323'}], 'facility': 'Équipe de recherche en vaccination', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual data will be shared with any other researchers outside of this study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}