Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-02-04 @ 6:21 PM
Study NCT ID:
NCT03183492
Status:
WITHDRAWN
Last Update Posted:
2018-03-02
First Post:
2017-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Persistence of GlaxoSmithKline (GSK) Biologicals' Havrix® in Healthy Adult Subjects Vaccinated at Infancy Under the Hepatitis A Universal Mass Vaccination (UMV) Program in Israel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006506', 'term': 'Hepatitis A'}], 'ancestors': [{'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022362', 'term': 'Hepatitis A Vaccines'}], 'ancestors': [{'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor cancelled the study as real life impact data has already shown the value of HepA vaccination \\& as no critical need to gather additional data in Israel.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-05-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2019-01-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-01', 'studyFirstSubmitDate': '2017-05-30', 'studyFirstSubmitQcDate': '2017-06-08', 'lastUpdatePostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of immunity to hepatitis A in terms of anti-HAV (Antibodies against Hepatitis A virus) seropositivity status.', 'timeFrame': 'At the pre-challenge time-point (Day 1)', 'description': 'A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value of 15mIU/mL.'}, {'measure': 'Evaluation of immunity to hepatitis A in terms of anti-HAV antibody concentrations.', 'timeFrame': 'At the pre-challenge time-point (Day 1)', 'description': 'Immunogenicity will be assessed in terms of Geometric Mean Concentration (GMC) of anti-HAV antibody concentrations.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of immunity to hepatitis A in terms of anti-HAV anamnestic response to hepatitis A vaccine challenge dose.', 'timeFrame': '30 days (Day 31) after challenge dose', 'description': 'Anti-HAV anamnestic response to the challenge dose is defined as:\n\nAt least a 4-fold increase in anti-HAV antibody concentrations in subjects seropositive at the pre-challenge time-point.\n\nAnti-HAV antibody concentrations at least 4 time the assay cut-off (i.e.60 mIU/mL) in subjects seronegative at the pre-challenge time-point.'}, {'measure': 'Evaluation of immunity to hepatitis A in terms of anti-HAV seropositivity status in response to hepatitis A vaccine challenge dose.', 'timeFrame': '30 days (Day 31) after challenge dose', 'description': 'A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value of 15mIU/mL .'}, {'measure': 'Evaluation of immunity to hepatitis A in terms of anti-HAV antibody concentrations in response to hepatitis A vaccine challenge dose.', 'timeFrame': '30 days (Day 31) after challenge dose', 'description': 'Immunogenicity will be assessed in terms of GMC of anti-HAV antibody concentrations.'}, {'measure': 'Occurrence of solicited local and general symptoms.', 'timeFrame': 'During the 4-day (Days 1-4) follow-up period after the challenge dose', 'description': 'The following local (injection-site) AEs will be solicited:\n\nPain at injection site, Redness at injection site, Swelling at injection site.\n\nThe following general AEs will be solicited:\n\nFatigue, Fever\\*, Gastrointestinal symptoms\\*\\*, Headache.\n\n\\*Fever is defined as temperature ≥38.0°C / 100.4°F. The preferred location for measuring temperature in this study will be the oral cavity.\n\n\\*\\*Gastrointestinal symptoms include nausea, vomiting, diarrhea and/or abdominal pain.\n\nThe AEs will be categorized depending on their intensity into the following grades:\n\n1. (mild) = An AE which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities.\n2. (moderate) = An AE which is sufficiently discomforting to interfere with normal everyday activities.\n3. (severe) = An AE which prevents normal, everyday activities.'}, {'measure': 'Occurrence of unsolicited symptoms, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification.', 'timeFrame': 'During the 31-day (Days 1-31) follow-up period after the challenge dose', 'description': 'Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.'}, {'measure': 'Occurrence of Serious Adverse Events (SAEs).', 'timeFrame': 'After the challenge dose up to the study end (Days 1-31)', 'description': 'SAEs to be assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Israel', 'Universal Mass Vaccination', 'Havrix®', 'Hepatitis A', 'Healthy adults', 'Long term persistence', 'Toddlers'], 'conditions': ['Hepatitis A']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the persistence, immunogenicity and safety of Havrix® (hepatitis A vaccine) in adults primed in infancy. The enrolled subjects will be assessed for circulating antibodies against hepatitis A and will also receive a challenge dose of Havrix Adult vaccine. In the present study, the anamnestic response will be assessed 30 days after the challenge dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '19 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol\n* Written informed consent obtained from the subject prior to performing any study specific procedure\n* A male or female subject aged 18 to 19 years at the time of enrolment (up to but excluding the 20th birthday)\n* Documented administration of 2 doses of Havrix® Junior in the second year of life\n* Healthy subjects as established by medical history and clinical examination before entering into the study\n* Female subjects of childbearing potential may be enrolled in the study, if the subject:\n\nhas practiced adequate contraception for 30 days prior to study vaccine administration, and has a negative pregnancy test on the day of vaccine administration, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study vaccine administration\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the dose of study vaccine (Day 29 to Day1), or planned use during the study period\n* Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe\n* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed\n* Administration of long-acting immune-modifying drugs at any time during the study entry\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product\n* Administration of any hepatitis A vaccine dose, with the exception of the two doses of routine toddler vaccination for the subjects\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine\n* Planned enrolment in the Israel Defense Forces within 30 days of study enrolment or activity that would prohibit the subject to return for Visit 2\n* Acute disease and/or fever at the time of enrolment Fever is defined as temperature ≥38.0°C / 100.4°F. The preferred location for measuring temperature in this study will be the oral cavity Subjects with a minor illness without fever may be enrolled at the discretion of the investigator\n* Pregnant or lactating female\n* Female planning to become pregnant or planning to discontinue contraceptive precautions'}, 'identificationModule': {'nctId': 'NCT03183492', 'briefTitle': "Immunogenicity and Persistence of GlaxoSmithKline (GSK) Biologicals' Havrix® in Healthy Adult Subjects Vaccinated at Infancy Under the Hepatitis A Universal Mass Vaccination (UMV) Program in Israel", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Long-term Persistence of Hepatitis A Immunity in Healthy Adults Vaccinated as Part of a Hepatitis A Universal Mass Vaccination Program', 'orgStudyIdInfo': {'id': '116762'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HAV Group', 'description': 'Subjects who were vaccinated under UMV with 2 doses of Havrix® Junior at infancy and will receive a single challenge dose of Havrix Adult at Visit 1 (Day 1).', 'interventionNames': ['Biological: Havrix®']}], 'interventions': [{'name': 'Havrix®', 'type': 'BIOLOGICAL', 'otherNames': ["GSK Biologicals' inactivated hepatitis A vaccine"], 'description': 'One challenge dose of Havrix® administered intramuscularly (IM) in the deltoid region of the non-dominant arm.', 'armGroupLabels': ['HAV Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}