Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-01 @ 8:57 PM
Study NCT ID:
NCT07133802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-21
First Post:
2025-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine (LAIV) in Adults Aged 18-59 Years Post-Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6680}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2025-08-14', 'studyFirstSubmitQcDate': '2025-08-14', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Protective Efficacy', 'timeFrame': 'at 14 days post-vaccination', 'description': 'To evaluate the protective efficacy of a nasal spray live attenuated influenza vaccine (LAIV) against laboratory-confirmed influenza in participants aged 18-59 years at 14 days post-vaccination'}], 'secondaryOutcomes': [{'measure': 'Protective Efficacy', 'timeFrame': 'at 14 days post-vaccination', 'description': 'To evaluate the protective efficacy of a nasal spray live attenuated influenza vaccine (LAIV) against laboratory-confirmed vaccine-matched influenza in participants aged 18-59 years at 14 days post-vaccination'}, {'measure': 'Protective Efficacy', 'timeFrame': 'Throughout the entire study period', 'description': 'To evaluate the protective efficacy of a nasal spray live attenuated influenza vaccine (LAIV) against laboratory-confirmed influenza in participants aged 18-59 years post-vaccination'}, {'measure': 'Protective Efficacy', 'timeFrame': 'Throughout the entire study period', 'description': 'To evaluate the protective efficacy of a nasal spray live attenuated influenza vaccine (LAIV) against laboratory-confirmed, vaccine-matched influenza in participants aged 18-59 years post-vaccination'}, {'measure': 'Safety', 'timeFrame': '14 days post-vaccination', 'description': 'Incidence of solicited adverse events (local and systemic) within 14 days post-vaccination'}, {'measure': 'Safety', 'timeFrame': '30 days post-vaccination', 'description': 'Incidence of unsolicited adverse events within 30 days post-vaccination'}, {'measure': 'Safety', 'timeFrame': 'During the study period', 'description': 'Incidence of serious adverse events (SAEs) in all participants from vaccination to end of study'}, {'measure': 'Safety', 'timeFrame': 'Day 15 post-vaccination', 'description': 'Viral shedding assessment at Day 3, Day 7, and Day 15 post-vaccination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prevention of Influenza']}, 'descriptionModule': {'briefSummary': 'A Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine (LAIV) in Adults Aged 18-59 Years Post-Vaccination'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy participants aged 18-59 years\n2. Capable of providing informed consent in person\n3. Willing and able to comply with all clinical trial requirements\n\nExclusion Criteria:\n\n1. Axillary temperature \\>37.0°C on enrollment day \\*\n2. Received any influenza vaccine within the past 6 months or plans to receive other influenza vaccines during the trial\n3. History of laboratory-confirmed influenza (by clinical, serological, or microbiological methods) within the past 6 months\n4. Female participants of childbearing potential with positive urine pregnancy test, currently breastfeeding, or planning pregnancy within 6 months\n5. Acute phase of any infectious disease/chronic illness within 3 days, or recent use (≤3 days) of antipyretics/analgesics/antihistamines \\*\n6. History of severe allergies requiring medical intervention (e.g., anaphylaxis, angioedema, Arthus reaction) or hypersensitivity to vaccine components (egg proteins, gentamicin sulfate, etc.)\n7. Known malignancies, autoimmune diseases (e.g., SLE, rheumatoid arthritis), or immunodeficiency (HIV, organ transplantation, etc.)\n8. Asplenia, functional asplenia, or any splenectomy history\n9. Use of immunosuppressants/immunomodulators (e.g., systemic corticosteroids \\>14 days) within 6 months or planned use during study\n10. Congenital anomalies affecting organ function, uncontrolled hypertension (≥140/90 mmHg despite treatment), or severe hepatic/renal diseases (e.g., diabetes-complicated)\n11. Active asthma or clinical remission for \\<12 months\n12. History or family history of neurological/psychiatric disorders (e.g., epilepsy, Guillain-Barré syndrome)\n13. Salicylate use (e.g., aspirin) within 30 days or planned use within 6 weeks post-vaccination\n14. Nasal abnormalities potentially affecting vaccine administration (e.g., active allergic rhinitis with medication, ongoing nasal sprays)\n15. Blood products/immunoglobulin administration within 3 months or planned use during trial\n16. Live-attenuated vaccines within 14 days or subunit/inactivated vaccines within 7 days prior to enrollment \\*\n17. Participation in other clinical trials within 1 month or concurrent involvement in interventional studies\n18. Any condition deemed by investigators to compromise trial integrity'}, 'identificationModule': {'nctId': 'NCT07133802', 'briefTitle': 'Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine (LAIV) in Adults Aged 18-59 Years Post-Vaccination', 'organization': {'class': 'INDUSTRY', 'fullName': 'Changchun BCHT Biotechnology Co.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine in Adults Aged 18-59 Years', 'orgStudyIdInfo': {'id': 'B1506-20250113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nasal Spray Live Attenuated Influenza Vaccine', 'interventionNames': ['Biological: Test Group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Biological: Placebo Group']}], 'interventions': [{'name': 'Placebo Group', 'type': 'BIOLOGICAL', 'description': 'Each human dose: 0.2 mL', 'armGroupLabels': ['Placebo']}, {'name': 'Test Group', 'type': 'BIOLOGICAL', 'description': 'Each human dose is 0.2 mL', 'armGroupLabels': ['Nasal Spray Live Attenuated Influenza Vaccine']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'huan xiao li', 'role': 'CONTACT', 'email': 'lixiaohuan@bchtpharm.com', 'phone': '0431-87078176'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changchun BCHT Biotechnology Co.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hubei Provincial Center for Disease Control and Prevention', 'class': 'OTHER'}, {'name': 'Center for Disease Control and Prevention, Fujian', 'class': 'OTHER'}, {'name': 'Zhejiang Provincial Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}