Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-31 @ 12:06 AM
Study NCT ID:
NCT01111968
Status:
COMPLETED
Last Update Posted:
2013-02-06
First Post:
2010-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines
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': 'C488512', 'term': 'hexavalent group A streptococcal vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 266}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-05', 'studyFirstSubmitDate': '2010-04-14', 'studyFirstSubmitQcDate': '2010-04-27', 'lastUpdatePostDateStruct': {'date': '2013-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay', 'timeFrame': '21 days after each vaccination', 'description': 'Volunteers will receive two doses of vaccine,21 days apart.'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability', 'timeFrame': '30 minutes and 72 hours after vaccination', 'description': 'Evaluation of local and systemic adverse effects throught the study period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['vaccine', 'pandemic influenza A', 'adjuvant', 'safety'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '21945258', 'type': 'DERIVED', 'citation': 'Precioso AR, Miraglia JL, Campos LM, Goulart AC, Timenetsky Mdo C, Cardoso MR, Luna E, Mondini G, Guedes Jda S, Raw I. A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems. Vaccine. 2011 Nov 8;29(48):8974-81. doi: 10.1016/j.vaccine.2011.09.040. Epub 2011 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective phase I study to evaluate the safety, tolerability and immunogenicity of nine adjuvanted candidate vaccines against pandemic influenza A (H1N1) virus.', 'detailedDescription': 'The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Health adults of both genders\n* Age ≥ 18 ≤ 50 years\n* Able to understand every required study procedure\n* Female volunteers should agree to take an acceptable contraceptive method Menopause is characterized by absence of menstrual flux for two consective years\n* Normal values for pre-stablished laboratory assays\n* Accpetance to participate and sign the consent form\n\nExclusion Criteria:\n\n* Any chronic condition\n* Be on immunossupressive or stimulant therapy\n* Have egg alergy\n* Have past history of alergy to sazonal influenza vaccine\n* Have received another inactivated vaccine within the prior 2 weeks or a live vaccine in the past four weeks to his/her participation in the study\n* Acute infectious disease during seven days prior vaccination\n* Female on breasthfeeding\n* Confirmed prior infection by pandemic influenza A\n* Participation in another clinical trial in the last 6 months\n* Any other condition identified by the principal investigator which is considered not safe for enrollment of the volunteer'}, 'identificationModule': {'nctId': 'NCT01111968', 'briefTitle': 'Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Butantan Institute'}, 'officialTitle': 'Evaluation of Safety, Tolerability and Immunogenicity of Adjuvanted Candidate Vaccines Against Pandemic Influenza A (H1N1)', 'orgStudyIdInfo': {'id': 'BUTVAC - Influenza A (H1N1)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pandemic vaccine 1', 'description': '7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3', 'interventionNames': ['Biological: pandemic vaccine 1']}, {'type': 'EXPERIMENTAL', 'label': 'pandemic vaccine 2', 'description': '3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3', 'interventionNames': ['Biological: pandemic vaccine 2']}, {'type': 'EXPERIMENTAL', 'label': 'pandemic vaccine 5', 'description': '7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion', 'interventionNames': ['Biological: pandemic vaccine 5']}, {'type': 'EXPERIMENTAL', 'label': 'pandemic vaccine 6', 'description': '3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion', 'interventionNames': ['Biological: pandemic vaccine 6']}, {'type': 'EXPERIMENTAL', 'label': 'pandemic vaccine 9', 'description': '7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion', 'interventionNames': ['Biological: pandemic vaccine 9']}, {'type': 'EXPERIMENTAL', 'label': 'pandemic vaccine 10', 'description': '3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion', 'interventionNames': ['Biological: pandemic vaccine 10']}, {'type': 'EXPERIMENTAL', 'label': 'pandemic vaccine 11', 'description': '7,5µg of A/H1N1 with Al(OH)3', 'interventionNames': ['Biological: pandmeic vaccine 11']}, {'type': 'EXPERIMENTAL', 'label': 'pandemic vaccine 12', 'description': '3,75µg of A/H1N1 with Al(OH)3', 'interventionNames': ['Biological: pandmeic vaccine 12']}, {'type': 'EXPERIMENTAL', 'label': 'pandemic vaccine 13', 'description': '15µg of A/H1N1 with no adjuvant', 'interventionNames': ['Biological: pandmic vaccine 13']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group 14', 'description': 'placebo', 'interventionNames': ['Biological: placebo group 14']}], 'interventions': [{'name': 'pandemic vaccine 1', 'type': 'BIOLOGICAL', 'otherNames': ['vaccine group C'], 'description': '7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3', 'armGroupLabels': ['pandemic vaccine 1']}, {'name': 'pandemic vaccine 2', 'type': 'BIOLOGICAL', 'otherNames': ['vaccine group I'], 'description': '3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3', 'armGroupLabels': ['pandemic vaccine 2']}, {'name': 'pandemic vaccine 5', 'type': 'BIOLOGICAL', 'otherNames': ['vaccine group N'], 'description': '7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion', 'armGroupLabels': ['pandemic vaccine 5']}, {'name': 'pandemic vaccine 6', 'type': 'BIOLOGICAL', 'otherNames': ['vaccine group A'], 'description': '3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion', 'armGroupLabels': ['pandemic vaccine 6']}, {'name': 'pandemic vaccine 9', 'type': 'BIOLOGICAL', 'otherNames': ['vaccine group F'], 'description': '7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion', 'armGroupLabels': ['pandemic vaccine 9']}, {'name': 'pandemic vaccine 10', 'type': 'BIOLOGICAL', 'otherNames': ['vaccine group L'], 'description': '3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion', 'armGroupLabels': ['pandemic vaccine 10']}, {'name': 'pandmeic vaccine 11', 'type': 'BIOLOGICAL', 'otherNames': ['vaccine group E'], 'description': '7,5µg of A/H1N1 with Al(OH)3', 'armGroupLabels': ['pandemic vaccine 11']}, {'name': 'pandmeic vaccine 12', 'type': 'BIOLOGICAL', 'otherNames': ['vaccine group K'], 'description': '3,75µg of A/H1N1 with Al(OH)3', 'armGroupLabels': ['pandemic vaccine 12']}, {'name': 'pandmic vaccine 13', 'type': 'BIOLOGICAL', 'otherNames': ['vaccine group H'], 'description': '15µg of A/H1N1 with no adjuvant', 'armGroupLabels': ['pandemic vaccine 13']}, {'name': 'placebo group 14', 'type': 'BIOLOGICAL', 'otherNames': ['vaccine group B'], 'description': 'All elements of the vaccine but antigen and adjuvant', 'armGroupLabels': ['placebo group 14']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05508000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Centro de Pesquisa Clínica do Hospital Universitário da USP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Lucia MA Campos, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Children´s Institute - School of Medicine of University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Butantan Institute', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Hospital Universitario da USP', 'class': 'UNKNOWN'}, {'name': 'University of Sao Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}