Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT00703651
Status:
COMPLETED
Last Update Posted:
2014-01-13
First Post:
2008-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C478242', 'term': 'vaxigrip'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-09', 'studyFirstSubmitDate': '2008-06-19', 'studyFirstSubmitQcDate': '2008-06-20', 'lastUpdatePostDateStruct': {'date': '2014-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine.', 'timeFrame': '21days post-vaccination'}, {'measure': 'To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine', 'timeFrame': '21 days post-vaccination and entire study duration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza', 'Orthomyxoviridae Infection', 'Inactivated, Split-virion influenza vaccine', 'Intradermal injection', 'Adults.'], 'conditions': ['Influenza', 'Orthomyxoviridae Infection', 'Myxovirus Infection']}, 'referencesModule': {'references': [{'pmid': '19341446', 'type': 'DERIVED', 'citation': 'Beran J, Ambrozaitis A, Laiskonis A, Mickuviene N, Bacart P, Calozet Y, Demanet E, Heijmans S, Van Belle P, Weber F, Salamand C. Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial. BMC Med. 2009 Apr 2;7:13. doi: 10.1186/1741-7015-7-13.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route.\n\nPrimary Objective:\n\nTo assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57 years.\n\nSecondary Objective:\n\nTo evaluate the safety profile during the 21-day period following each vaccination in each study group', 'detailedDescription': 'This is an open (for the administration route) and double-blind (only for the two dosages administered at year 0 by using the investigational administration route) randomized trial conducted in subjects aged 18 to 60 years. The subjects will receive three vaccine injections at 1-year interval.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '57 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* Subject aged between 18 and 57 years (i.e., less than 60 at the last vaccination)\n* For woman of child-bearing potential, negative urine pregnancy test at V#01\n* Use of effective contraception prior to and during the trial\n* Subject available during the trial period\n* Subject able to read and understand the informed consent form\n* Informed consent form signed and dated by the subject prior to any protocol-required intervention (and Visit 05 and Visit 07, respectively).\n\nExclusion Criteria :\n\n* Self-reported allergy to egg proteins, chick proteins, or any of the constituents of the vaccine, in particular, neomycin, formaldehyde, and octoxinol 9\n* Acute febrile disease within the 72 hours preceding V#01, or axillary temperature \\>37.5°C the day of inclusion, prior to vaccination (\\>37.0°C Czech Republic)\n* Subject with an aggravation of existing chronic illness (heart disease, respiratory disease, etc.)\n* Vaccination against influenza within the 6 months preceding V#01\n* Any vaccination within the 28 days preceding V#01 or scheduled between V#01 and V#02\n* Breast-feeding\n* Immunosuppressive therapy including long term systemic corticotherapy (20 mg/day of prednisolone or equivalent for \\>2 weeks) or cancer therapy within the month preceding V#01 or ongoing\n* Immunoglobulin injection within the 3 months preceding V#01\n* Subject taking part or planned to take part in another clinical trial (3 months before and through the trial duration)\n* Subject having received extracted pituitary hormones\n* Subjects who participated in the GID01 study (Lithuanian centers)'}, 'identificationModule': {'nctId': 'NCT00703651', 'briefTitle': 'Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Vaxigrip® in Adults', 'orgStudyIdInfo': {'id': 'GID02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Biological: Inactivated, split-virion influenza vaccine']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Biological: Inactivated, split-virion influenza vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Biological: Inactivated, split-virion influenza vaccine']}], 'interventions': [{'name': 'Inactivated, split-virion influenza vaccine', 'type': 'BIOLOGICAL', 'description': '0.1 mL, ID. 1 injection/year for 3 years', 'armGroupLabels': ['1']}, {'name': 'Inactivated, split-virion influenza vaccine', 'type': 'BIOLOGICAL', 'description': '0.1 mL, ID. 1 injection/year for 3 years.', 'armGroupLabels': ['2']}, {'name': 'Inactivated, split-virion influenza vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Vaxigrip®'], 'description': '0.5 mL, IM. 1 injection/year for 3 years', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gribomont', 'country': 'Belgium', 'geoPoint': {'lat': 49.82166, 'lon': 5.3243}}, {'city': 'Kraainem', 'country': 'Belgium', 'geoPoint': {'lat': 50.86155, 'lon': 4.46946}}, {'city': 'Linkebeek', 'country': 'Belgium', 'geoPoint': {'lat': 50.76781, 'lon': 4.33688}}, {'city': 'Molenbeek', 'country': 'Belgium', 'geoPoint': {'lat': 50.91963, 'lon': 4.94163}}, {'city': 'Thuin', 'country': 'Belgium', 'geoPoint': {'lat': 50.33933, 'lon': 4.28604}}, {'city': 'Hradec Králové', 'country': 'Czechia', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Kaunas', 'country': 'Lithuania', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'city': 'Vilnius', 'country': 'Lithuania', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasterur Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}