Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-26 @ 12:40 AM
Study NCT ID:
NCT00325260
Status:
COMPLETED
Last Update Posted:
2006-11-01
First Post:
2006-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-Inferiority Study Comparing the Subunit Vaccines Influvac and Agrippal in China
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568705', 'term': 'influvac'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 900}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'lastUpdateSubmitDate': '2006-10-31', 'studyFirstSubmitDate': '2006-05-11', 'studyFirstSubmitQcDate': '2006-05-11', 'lastUpdatePostDateStruct': {'date': '2006-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HI titers 4 weeks after vaccination (efficacy) and safety and tolerability'}], 'secondaryOutcomes': [{'measure': 'HI derived parameters: seroprotection, seroconversion and mean fold increase 4 weeks after vaccination'}]}, 'conditionsModule': {'keywords': ['influenza', 'non-inferiority', 'Influvac', 'Agrippal', 'healthy subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'In the study Influvac will be compared to Agrippal, another subunit influenza vaccine that is already on the market in China. The main objective of the study is to show that both vaccines are comparable with regard to efficacy. In addition, safety and efficacy data with Influvac will be assessed in the Chinese population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed and dated informed consent\n* being healthy\n* mental health enough to understand the study, the informed consent form and the questionnaire\n\nExclusion Criteria:\n\n* known to be allergic to constituents of the vaccine\n* having an autoimmune disorder, taking immunomodulating drugs or having immune disfunction secondary to HIV\n* having had a documented serious adverse reaction to previous influenza vaccination\n* having had documented influenza infection or vaccination in the six months prior to the start of the study\n* having received any other vaccines, immunoglobulins or investigational drugs in the month prior to the start of the study'}, 'identificationModule': {'nctId': 'NCT00325260', 'briefTitle': 'Non-Inferiority Study Comparing the Subunit Vaccines Influvac and Agrippal in China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solvay Pharmaceuticals'}, 'officialTitle': 'A Randomized, Endpoint-Blind, Parallel Group Study to Demonstrate the Non-Inferiority of the Subunit Influenza Vaccine Influvac® to the Subunit Influenza Vaccine Agrippal® in Healthy Children, Adults and Elderly in China.', 'orgStudyIdInfo': {'id': 'S201.3.121'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Influvac; subunit influenza vaccine', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'country': 'China', 'facility': 'Site 1', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Global Clinical Director Solvay', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Solvay Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solvay Pharmaceuticals', 'class': 'INDUSTRY'}}}}