Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Changchun BCHT Biotechnology Co.
Collaborating Sponsors:
Hubei Provincial Center for Disease Control and Prevention
Center for Disease Control and Prevention, Fujian
Conditions:
Prevention of Influenza
Eligibility:
All Genders
18-59 years
Phase:
PHASE3
Brief Summary
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
Eligibility Criteria
Inclusion
- Healthy participants aged 18-59 years
- Capable of providing informed consent in person
- Willing and able to comply with all clinical trial requirements
Exclusion
- Axillary temperature \>37.0°C on enrollment day \*
- Received any influenza vaccine within the past 6 months or plans to receive other influenza vaccines during the trial
- History of laboratory-confirmed influenza (by clinical, serological, or microbiological methods) within the past 6 months
- Female participants of childbearing potential with positive urine pregnancy test, currently breastfeeding, or planning pregnancy within 6 months
- Acute phase of any infectious disease/chronic illness within 3 days, or recent use (≤3 days) of antipyretics/analgesics/antihistamines \*
- History of severe allergies requiring medical intervention (e.g., anaphylaxis, angioedema, Arthus reaction) or hypersensitivity to vaccine components (egg proteins, gentamicin sulfate, etc.)
- Known malignancies, autoimmune diseases (e.g., SLE, rheumatoid arthritis), or immunodeficiency (HIV, organ transplantation, etc.)
- Asplenia, functional asplenia, or any splenectomy history
- Use of immunosuppressants/immunomodulators (e.g., systemic corticosteroids \>14 days) within 6 months or planned use during study
- Congenital anomalies affecting organ function, uncontrolled hypertension (≥140/90 mmHg despite treatment), or severe hepatic/renal diseases (e.g., diabetes-complicated)
- Active asthma or clinical remission for \<12 months
- History or family history of neurological/psychiatric disorders (e.g., epilepsy, Guillain-Barré syndrome)
- Salicylate use (e.g., aspirin) within 30 days or planned use within 6 weeks post-vaccination
- Nasal abnormalities potentially affecting vaccine administration (e.g., active allergic rhinitis with medication, ongoing nasal sprays)
- Blood products/immunoglobulin administration within 3 months or planned use during trial
- Live-attenuated vaccines within 14 days or subunit/inactivated vaccines within 7 days prior to enrollment \*
- Participation in other clinical trials within 1 month or concurrent involvement in interventional studies
- Any condition deemed by investigators to compromise trial integrity
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
6680 Patients enrolled
Trial Details
Trial ID
NCT07133802
Start Date
August 1 2025
End Date
July 1 2026
Last Update
August 21 2025
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