Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-28 @ 10:44 PM
Study NCT ID:
NCT05284851
Status:
UNKNOWN
Last Update Posted:
2022-03-17
First Post:
2022-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The design of this trail is based on random, one-blind, placebo control. The subjects will not know the masking status, unless the specific subjects who required treatment for serious adverse events .'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Totally 2520 health people aged 3-59 years old will be divided into two age group, containing 1260 in 18-59 years old and 1260 in 3-19 years old. All subjects will receive vaccination either LAVI(non freeze- dried), LAVI(freeze- dried) or placebo in a ratio of 2:2:1.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2520}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2022-03-09', 'studyFirstSubmitQcDate': '2022-03-09', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of participants with positive sIgA as assessed by SAS v9.4', 'timeFrame': 'within 10 days after vaccination', 'description': 'The Mucosal convention rate of sIgA in all subjects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunogenicity', 'Safety', 'Live Attenuated Influenza Vaccine'], 'conditions': ['Influenza Prevention']}, 'descriptionModule': {'briefSummary': 'Live Attenuated freeze-dried Influenza Vaccine has been licensed for use in 2020 (Approval No.S20200002), the sponsor of this research submitted an new application for non freeze-dried Live Attenuated Influenza Vaccine in 2021. The main objective of phase two trail is to evaluate the immunogenicity of LAVI (non freeze- dried). The secondary objective is to evaluate the safety of LAVI (non freeze- dried).', 'detailedDescription': 'Totally 2520 health people aged 3-59 years old will be divided into two age group, containing 1260 in 18-59 years old and 1260 in 3-19 years old. All subjects will receive vaccination either LAVI(non freeze- dried), LAVI(freeze- dried) or placebo in a ratio of 2:2:1.\n\nAll subjects will be collected any adverse events within 30 days and any serious adverse events within 6 months for safety evaluation. All subjects will be collected blood sample and nasopharyngeal swab for immunogenicity evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '59 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers aged in 3-59 years old\n* Had not received vaccination of Influenza vaccine in the past one year\n* Had not infected with Influenza virus\n* This trail has been agreed by volunteers or his/her legal guardian\n* Volunteers or his/her legal guardian will fellow this trail protocol\n\nExclusion Criteria:\n\n* People with fever before vaccination, temperature higher than 37.0 #\n* Females in suckling period, pregnancy (pregnancy test positive) or prepared to be pregnant\n* People given whole blood, plasma or immunoglobulin therapy within 3 months before vaccination\n* According to judgement of researchers, the subjects have any other factors that are not appropriate for this clinical trials\n* Acute infectious disease or acute attack of chronic disease before inoculation\n* People get any vaccine within 14 days before the trial\n* People in immune deficiency or diagnosed with congenital or acquired immunodeficiency, people with immunosuppressive therapy in the past six months\n* People with epilepsy or a history of mental illness'}, 'identificationModule': {'nctId': 'NCT05284851', 'briefTitle': 'The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Changchun BCHT Biotechnology Co.'}, 'officialTitle': 'A Random, Double-Blind, Multicenter, Positive Control and Placebo Control Phase Two Trail to Evaluate the Safety and Immunogenicity of Live Attenuated Influenza Vaccine in 3-59y Healthy People', 'orgStudyIdInfo': {'id': 'Bchtpharm'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group 1', 'description': 'Healthy people in experimental group will receive a dose of Live Attenuated Influenza Vaccine (non freeze- dried)', 'interventionNames': ['Biological: Live Attenuated Influenza Vaccine(non freeze-dried)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Positive control group', 'description': 'Healthy people in Positive control group will receive a dose of Live Attenuated Influenza Vaccine ( freeze- dried)', 'interventionNames': ['Biological: Live Attenuated Influenza Vaccine(freeze-dried)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Healthy people in placebo group will receive a dose of placebo', 'interventionNames': ['Biological: Live Attenuated Influenza Vaccine placebo']}], 'interventions': [{'name': 'Live Attenuated Influenza Vaccine(non freeze-dried)', 'type': 'BIOLOGICAL', 'description': 'Live Attenuated Influenza Vaccine Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.', 'armGroupLabels': ['Experimental group 1']}, {'name': 'Live Attenuated Influenza Vaccine(freeze-dried)', 'type': 'BIOLOGICAL', 'description': 'Live Attenuated Influenza Vaccine Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.', 'armGroupLabels': ['Positive control group']}, {'name': 'Live Attenuated Influenza Vaccine placebo', 'type': 'BIOLOGICAL', 'description': 'Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050021', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Hebei Provincial Center for Disease Control and Prevention', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changchun BCHT Biotechnology Co.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'He Bei province Center for Disease control and prevention', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}