Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT00322361
Status:
COMPLETED
Last Update Posted:
2017-03-16
First Post:
2006-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 566}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-15', 'studyFirstSubmitDate': '2006-05-02', 'studyFirstSubmitQcDate': '2006-05-04', 'lastUpdatePostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric mean titer to hepatitis B surface antigen at Month 7', 'timeFrame': '4 weeks Post Dose 3'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability including use of Vaccination Report Card', 'timeFrame': 'Follow-up 14 days Post Vaccination 1, 2, & 3 (Via Vaccination Report Card)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis B', 'Hepatocellular Carcinoma']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/policies-perspectives.html', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '22227229', 'type': 'DERIVED', 'citation': 'Minervini G, McCarson BJ, Reisinger KS, Martin JC, Stek JE, Atkins BM, Nadig KB, Liska V, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy neonates. Vaccine. 2012 Feb 14;30(8):1476-80. doi: 10.1016/j.vaccine.2011.12.095. Epub 2012 Jan 5.'}], 'seeAlsoLinks': [{'url': 'http://www.merck.com/clinical-trials/policies-perspectives.html', 'label': 'Click here to access a synopsis of the study results.'}]}, 'descriptionModule': {'briefSummary': 'Hepatitis B Vaccine \\[Recombinant\\] is a well-established vaccine which has been used extensively, worldwide since its initial licensure in 1986. Hepatitis B vaccines: \\[1\\] induce protection against the morbidity and mortality of acute hepatitis B virus infection, \\[2\\] reduce the incidence of chronic infection in vaccinated populations, and \\[3\\] thereby, reduce the incidence of hepatocellular carcinoma. The purpose of the trial is to assess if the new manufacturing process of the Hepatitis B Vaccine \\[Recombinant\\] vaccine shows the same level of hepatitis B antibody response or better as the currently licensed Hepatitis B Vaccine \\[Recombinant\\] vaccine. This study will also confirm that the new process vaccine is as well tolerated as the current vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Days', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 10 days of age)\n* Born to mothers with documented negative test for HBsAg within 9 months prior to delivery\n\nExclusion Criteria:\n\n* Infant born to mother with no prenatal care\n* Known or suspected impairment of immunologic function\n* Prior vaccination with any hepatitis B vaccine for infant or mother(within 6 months prior to the birth of infant.)\n* Recent(\\<72 hours) history of febrile illness \\>/= 99.5 degrees F (\\>/= 37.5 degrees C) axillary or \\>/= 100.5 degrees F (\\>/= 38.1 degrees C) rectal\n* Any prior administration of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product, or the receipt by the mother of either immunoglobulin or HBIG within 6 months prior to birth of the infant\n* Receipt of investigational vaccines by mother or infant within 3 months prior to first injection with study vaccine or if scheduled to be given to the infant during the study\n* Known or suspected hypersensitivity to any component of study vaccine (e.g., aluminum, yeast)\n* Any infant who cannot be adequately followed for study visits during the course of the clinical study\n* Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives'}, 'identificationModule': {'nctId': 'NCT00322361', 'briefTitle': 'Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Study in Healthy Neonates of Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured Using a Modified Process', 'orgStudyIdInfo': {'id': 'V232-056'}, 'secondaryIdInfos': [{'id': '2006_007'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Modified Process Hepatitis B Vaccine', 'interventionNames': ['Biological: Comparator: Modified process Hepatitis B Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Recombivax HB™', 'interventionNames': ['Biological: Comparator: RECOMBIVAX HB™']}], 'interventions': [{'name': 'Comparator: RECOMBIVAX HB™', 'type': 'BIOLOGICAL', 'description': 'RECOMBIVAX HB™ 3 x 5-mcg regimen administered via intramuscular injection.', 'armGroupLabels': ['2']}, {'name': 'Comparator: Modified process Hepatitis B Vaccine', 'type': 'BIOLOGICAL', 'description': 'Modified Process Hepatitis B 3 x 5-mcg regimen administered via intramuscular injection.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}