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
Not Applicable
Not yet recruiting
- Conditions
- Prevention of Influenza
- Interventions
- Biological: Test GroupBiological: Placebo Group
- Registration Number
- NCT07133802
- Lead Sponsor
- Changchun BCHT Biotechnology Co.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 6680
Inclusion Criteria
- Healthy participants aged 18-59 years
- Capable of providing informed consent in person
- Willing and able to comply with all clinical trial requirements
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nasal Spray Live Attenuated Influenza Vaccine Test Group - Placebo Placebo Group -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Protective Efficacy Throughout the entire study period 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
Safety Day 15 post-vaccination Viral shedding assessment at Day 3, Day 7, and Day 15 post-vaccination