Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-26 @ 3:21 PM
Study NCT ID:
NCT00496327
Status:
COMPLETED
Last Update Posted:
2019-01-18
First Post:
2007-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX in Healthy Indian Children (V210-056)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002644', 'term': 'Chickenpox'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053061', 'term': 'Herpes Zoster Vaccine'}], 'ancestors': [{'id': 'D019433', 'term': 'Chickenpox Vaccine'}, {'id': 'D022283', 'term': 'Herpesvirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2005-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-16', 'studyFirstSubmitDate': '2007-07-03', 'studyFirstSubmitQcDate': '2007-07-03', 'lastUpdatePostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of subjects with VZV specific antibody titre>= 5gp ELISA units/ml 6 weeks post-vaccination', 'timeFrame': '6 weeks post-vaccination'}]}, 'conditionsModule': {'conditions': ['Varicella']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/policies-perspectives.html', 'type': 'CSR Synopsis'}], 'references': [{'type': 'RESULT', 'citation': 'Subba Rao SD, Panday S, Maiya PP, Samdani PG, Lokeshwar MR, Bhave S, Bafna S. Immunogenecity and safety of Oka varicella-zoster virus vaccine (VaripedTM) in Indian children. New Indian Journal of Pediatrics. 2018;7.1(Jan-Mar):7-14. https://nijp.org/immunogenicity-and-safety-of-oka-varicella-zoster-virus-vaccine-varipedtm-in-indian-children/'}]}, 'descriptionModule': {'briefSummary': 'To observe the safety and tolerability of the administration of VARIVAX in varicella history negative Indian children 12 months to 12 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Children, Between 12 Months And 12 Years Of Age\n* Parent Or Legal Guardian Should Be Willing And Able To Sign The Informed Consent Form Prior To Entry Into The Study\n\nExclusion Criteria:\n\n* Any Immune Impairment Or Deficiency, Neoplastic Disease, Or Depressed Immunity, Including That Resulting From Corticosteroid Or Other Immunosuppressive Therapy\n* Any Immunoglobulin Or Blood Products 5 Months Prior To Or Expected Within 3 Months After Enrollment In This Study\n\nAny Medical Condition Which, In The Opinion Of The Investigator May Interfere With The Evaluation Of Teh Study Objectives\n\n* Any Other Inactivated Vaccine Administered Within 14 Days Before Or Expected Within 42 Days After Administration Of The Study Vaccination\n* Any Other Live Vaccine Administered Within 30 Days Before Or Expected Within 42 Days After Administration Of The Study Vaccination\n* Female Subjects Who Are Pregnant Or Nursing\n* History Of Anaphylactic Or Other Immediate Allergic Reactions\n* Hypersensitivity To Any Of The Components Of The Vaccine Administered Under This Protocol Such As Gelatin Or Neomycin\n* Past History Of Varicella\n* Previous Vaccination With Any Varicella Vaccine In Either Monovalent Or Combination Form\n* Recent Household, Daycare, Or School Exposure(In The Last 4 Weeks) To Varicella'}, 'identificationModule': {'nctId': 'NCT00496327', 'briefTitle': 'Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX in Healthy Indian Children (V210-056)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX (V210)in Healthy Indian Children', 'orgStudyIdInfo': {'id': 'V210-056'}, 'secondaryIdInfos': [{'id': '2007_019'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Open label', 'interventionNames': ['Biological: Varicella Virus Vaccine Live (Oka-Merck)']}], 'interventions': [{'name': 'Varicella Virus Vaccine Live (Oka-Merck)', 'type': 'BIOLOGICAL', 'description': 'VARIVAX(TM) (Refrigerated) \\[Varicella Virus Vaccine Live (Oka/Merck), Refrigerator-Stable Formulation.\\] Subjects enrolled in the study received one 0.5 mL subcutaneous dose of VARIVAX(TM). Frequency is single dose.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}