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
- 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
- Short 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
- Official title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2026-07-01
- First posted
- 2025-08-21
- Registry last updated
- 2025-08-21
- Primary completion date
- 2026-03-01
- Start date
- 2025-08-01
- Participants
- 6,680
- Participant count basis
- Estimated
- Planned participants
- 6,680
- Protocol amendments
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07133802
- ClinicalTrials.gov ID
- NCT07133802
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Triple masking
- Masked roles
- Participants, Investigators, Outcome assessors
Protective Efficacy
Timeframe: 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
Protective Efficacy
Timeframe: 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
Protective Efficacy
Timeframe: Throughout the entire study period
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
Protective Efficacy
Timeframe: 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
Timeframe: 14 days post-vaccination
Incidence of solicited adverse events (local and systemic) within 14 days post-vaccination
Safety
Timeframe: 30 days post-vaccination
Incidence of unsolicited adverse events within 30 days post-vaccination
Safety
Timeframe: During the study period
Incidence of serious adverse events (SAEs) in all participants from vaccination to end of study
Safety
Timeframe: Day 15 post-vaccination
Viral shedding assessment at Day 3, Day 7, and Day 15 post-vaccination
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 59 Years
- Healthy volunteers
- Yes
- Healthy participants aged 18-59 years
- Capable of providing informed consent in person
- Willing and able to comply with all clinical trial requirements
- 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
Related records
Drugs (1)
Collaborators (3)
- Center for Disease Control and Prevention, Fujian
- Hebei Provincial Center for Disease Control and Prevention
- Zhejiang Provincial Center for Disease Control and Prevention