Prevention of Influenza
Conditions
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
Interventions
BIOLOGICALPlacebo Group
Each human dose: 0.2 mL
BIOLOGICALTest Group
Each human dose is 0.2 mL
Sponsors
Hubei Provincial Center for Disease Control and Prevention
Center for Disease Control and Prevention, Fujian
Zhejiang Provincial Center for Disease Control and Prevention
Changchun BCHT Biotechnology Co.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy participants aged 18-59 years 2. Capable of providing informed consent in person 3. Willing and able to comply with all clinical trial requirements
Exclusion criteria
1. Axillary temperature \>37.0°C on enrollment day \* 2. Received any influenza vaccine within the past 6 months or plans to receive other influenza vaccines during the trial 3. History of laboratory-confirmed influenza (by clinical, serological, or microbiological methods) within the past 6 months 4. Female participants of childbearing potential with positive urine pregnancy test, currently breastfeeding, or planning pregnancy within 6 months 5. Acute phase of any infectious disease/chronic illness within 3 days, or recent use (≤3 days) of antipyretics/analgesics/antihistamines \* 6. History of severe allergies requiring medical intervention (e.g., anaphylaxis, angioedema, Arthus reaction) or hypersensitivity to vaccine components (egg proteins, gentamicin sulfate, etc.) 7. Known malignancies, autoimmune diseases (e.g., SLE, rheumatoid arthritis), or immunodeficiency (HIV, organ transplantation, etc.) 8. Asplenia, functional asplenia, or any splenectomy history 9. Use of immunosuppressants/immunomodulators (e.g., systemic corticosteroids \>14 days) within 6 months or planned use during study 10. Congenital anomalies affecting organ function, uncontrolled hypertension (≥140/90 mmHg despite treatment), or severe hepatic/renal diseases (e.g., diabetes-complicated) 11. Active asthma or clinical remission for \<12 months 12. History or family history of neurological/psychiatric disorders (e.g., epilepsy, Guillain-Barré syndrome) 13. Salicylate use (e.g., aspirin) within 30 days or planned use within 6 weeks post-vaccination 14. Nasal abnormalities potentially affecting vaccine administration (e.g., active allergic rhinitis with medication, ongoing nasal sprays) 15. Blood products/immunoglobulin administration within 3 months or planned use during trial 16. Live-attenuated vaccines within 14 days or subunit/inactivated vaccines within 7 days prior to enrollment \* 17. Participation in other clinical trials within 1 month or concurrent involvement in interventional studies 18. Any condition deemed by investigators to compromise trial integrity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protective Efficacy | at 14 days post-vaccination | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Protective Efficacy | at 14 days post-vaccination | 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 |
| Safety | 14 days post-vaccination | Incidence of solicited adverse events (local and systemic) within 14 days post-vaccination |
Contacts
Primary Contacthuan xiao li
Outcome results
None listed