Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-02 @ 8:20 AM
Study NCT ID:
NCT01656356
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2012-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Safety and Immunogenicity of Live Attenuated Influenza H5 Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2) in Healthy Thai Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005585', 'term': 'Influenza in Birds'}], 'ancestors': [{'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001715', 'term': 'Bird Diseases'}, {'id': 'D000820', 'term': 'Animal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'lastUpdateSubmitDate': '2012-08-07', 'studyFirstSubmitDate': '2012-07-25', 'studyFirstSubmitQcDate': '2012-08-02', 'lastUpdatePostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Avian Flu', 'H5N2'], 'conditions': ['Preventive Avian Flu']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety and reactogenicity of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO, in Thailand to previously healthy Thais.', 'detailedDescription': 'It is a phase I randomized placebo controlled trial (vaccine and placebo ratio of 2:1). A phase II study is planned to be conducted following review of results of this phase.\n\nPhase I: It is a double blind randomized placebo controlled trial involving 24 participants age 18-49 years (16 will receive vaccines and 8 will receive placebo). All will be admitted in the isolation ward for 10-14 days after each immunization mainly for safety assessment. Two doses of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) will be given by intranasal route 21 days apart. Each group of 4 participants will be immunized at a time at 30-60 mins interval. All participants will be followed 21 days after each immunization. Total follow up is 60 day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Age 18-49 years old\n* Having Thai ID card or equivalent\n* Are seronegative to the specific H5 influenza virus determined by antibody titer less than 1:40 by HAI test to the corresponding antigen.\n* Anti HIV - Negative\n* All hematology \\& biochemistry and urine analysis are within normal range or of no clinical significance (not more than 1.5 times of normal value)\n* Able to read and write and sign written informed consent.\n\nExclusion Criteria:\n\n* Known history of egg allergy\n* Having had recently influenza infection confirmed as H5\n* History of bronchial asthma\n* History of chronic lung diseases\n* History of chronic rhinitis\n* History of immunodeficiency state\n* History of immunosuppression\n* History of heavy smoking (more than 5 rolls per day)\n* History of alcoholic (pure drink 200 ml per day)\n* Acute infectious and noninfectious diseases (within 2 weeks)\n* Exacerbation of chronic diseases or cancer or HIV positives\n* Anamnestic leukocytosis, hepatitis B and C positives\n* The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past three months before the beginning of the experiment\n* Participation in other research study or stop participant less than 1 month\n* Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding\n* Any concomitant medication with Aspirin\n* The volunteers who have family members with immunodeficiency\n* Poultry workers\n* Have undertaken international travel within the one week prior to immunization'}, 'identificationModule': {'nctId': 'NCT01656356', 'briefTitle': 'Phase I Safety and Immunogenicity of Live Attenuated Influenza H5 Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2) in Healthy Thai Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Phase I Safety and Immunogenicity of Live Attenuated Influenza H5 Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2) in Healthy Thai Volunteers', 'orgStudyIdInfo': {'id': 'GPO AVIAN FLU Vaccine-V02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A/17/turkey/Turkey/05/133 (H5N2)', 'interventionNames': ['Biological: Avian Flu Vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Avian Flu Vaccine', 'type': 'BIOLOGICAL', 'armGroupLabels': ['A/17/turkey/Turkey/05/133 (H5N2)']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Tropical Medicine', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Punnee Pitisuttithum', 'investigatorAffiliation': 'Mahidol University'}}}}