Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-01-01 @ 5:31 PM
Study NCT ID:
NCT00731393
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2008-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-14', 'studyFirstSubmitDate': '2008-08-07', 'studyFirstSubmitQcDate': '2008-08-07', 'lastUpdatePostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GMT of the haemagglutination-inhibiting (HI) antibodies and calculation of seroconversion factor, seroconversion rate & seroprotection rate, checked against CHMP criteria (for 18 - 60 years old); seroprotection power is also calculated.', 'timeFrame': 'On Day 21 (+- 2) after the second vaccination'}], 'secondaryOutcomes': [{'measure': 'Descriptive comparison of the occurrence and severity of solicited local and general symptoms', 'timeFrame': 'Within 4 days after each vaccination'}, {'measure': 'Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms', 'timeFrame': 'Within 30 days after each vaccination'}, {'measure': 'Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs).', 'timeFrame': 'Throughout the study'}, {'measure': 'GMT of the HI antibodies in each case against the 3 influenza virus strains of the vaccine separately for both age groups.', 'timeFrame': 'On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thiomersal-free influenza split vaccine 2003/2004', 'Influsplit SSW®/Fluarix™ 2003/2004', 'Influenza'], 'conditions': ['Influenza']}, 'referencesModule': {'availIpds': [{'id': '100351', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '100351', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '100351', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '100351', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '100351', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '100351', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '100351', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to assess the reactogenicity and immunogenicity of a thiomersal-free influenza vaccine. For comparison, a group of subjects is administered the standard formulation of Influsplit SSW® 2003/2004.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol\n* Male or female children over 6 months of age at the time of vaccination, but who are not yet 6 years old.\n* All children included in the study must never have been given a prophylactic influenza inoculation.\n* Written consent to vaccination must be available from both parents or only the single parent after the parents/guardians have been briefed on the study in an understandable language.\n\nExclusion Criteria:\n\n* Use of study or unlicensed medication or administration of a vaccine other than the study vaccine within 30 days preceding vaccination and/or during the study period until 30 days after administration of the second vaccine dose.\n* Acute disease at the beginning of the study\n* Acute clinically significant changes in the lungs, cardiovascular system, liver or kidney function, identified by physical examination or laboratory tests.\n* Known allergic reactions that might have been caused by one or more components of the vaccine.\n* Administration of immunoglobulins and/or other blood products within 3 months before the beginning of the study or planned administration during the study period.'}, 'identificationModule': {'nctId': 'NCT00731393', 'briefTitle': 'Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "To Determine the Immunogenicity and Reactogenicity of a Thiomersal Free Trivalent Influenza Split Vaccine 2003/2004 or of GSK Biologicals' Standard Formulation Influsplit SSW®/Fluarix™ 2003/2004 in Children Aged From 6 Months Until 6 Years", 'orgStudyIdInfo': {'id': '100351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Subjects aged between 6 months and 3 years.', 'interventionNames': ['Biological: Thiomersal free trivalent influenza split vaccine 2003/2004']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Subjects aged 3 to 6 years.', 'interventionNames': ['Biological: Thiomersal free trivalent influenza split vaccine 2003/2004']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'Subjects aged between 6 months and 3 years.', 'interventionNames': ["Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D', 'description': 'Subjects aged 3 to 6 years.', 'interventionNames': ["Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004"]}], 'interventions': [{'name': 'Thiomersal free trivalent influenza split vaccine 2003/2004', 'type': 'BIOLOGICAL', 'description': '2 doses, intramuscular injection', 'armGroupLabels': ['Group A', 'Group B']}, {'name': "GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004", 'type': 'BIOLOGICAL', 'otherNames': ['Thiomersal free trivalent influenza split vaccine 2003/2004'], 'description': '2 doses, intramuscular injection', 'armGroupLabels': ['Group C', 'Group D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18246', 'city': 'Bützow', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.84133, 'lon': 11.98145}}, {'zip': '18106', 'city': 'Rostock', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '01877', 'city': 'Bischofswerda', 'state': 'Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.12771, 'lon': 14.17974}}, {'zip': '01640', 'city': 'Coswig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.13204, 'lon': 13.58312}}, {'zip': '01169', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '04209', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '23795', 'city': 'Bad Segeberg', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.93775, 'lon': 10.30745}}, {'zip': '24937', 'city': 'Flensburg', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 54.78805, 'lon': 9.43722}}, {'zip': '25813', 'city': 'Husum', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 54.4858, 'lon': 9.05239}}, {'zip': '10315', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12627', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13355', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], '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'}}}}