> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/clinical-trial-to-evaluate-the-protective-efficacy-and-b1773017-7d13-4e2d-8585-5d8adce252ec > Record changed: 2026-10-13 # 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 NCT07133802 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) Participants 6,680 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) Lead sponsor Changchun BCHT Biotechnology Co. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) Start date 2025-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) ## Dates **Completion date** 2026-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **First posted** 2025-08-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **Registry last updated** 2025-08-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **Primary completion date** 2026-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **Start date** 2025-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) ## Size and sites **Participants** 6,680 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **Planned participants** 6,680 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **Lead sponsor** Changchun BCHT Biotechnology Co. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) ## Identifiers **Registry ID** NCT07133802 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **ClinicalTrials.gov ID** NCT07133802 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Triple masking **Masked roles** Participants, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) ## Outcomes ### Primary outcomes 1. 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 ### Secondary outcomes 1. 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 2. 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 3. 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 4. Safety Timeframe: 14 days post-vaccination Incidence of solicited adverse events (local and systemic) within 14 days post-vaccination 5. Safety Timeframe: 30 days post-vaccination Incidence of unsolicited adverse events within 30 days post-vaccination 6. Safety Timeframe: During the study period Incidence of serious adverse events (SAEs) in all participants from vaccination to end of study 7. Safety Timeframe: Day 15 post-vaccination Viral shedding assessment at Day 3, Day 7, and Day 15 post-vaccination Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07133802) ## Related records ### Drugs (1) - [Nadroparin calcium](https://trialight.com/data/asset/nadroparin-calcium-e2fda760-ec53-4849-9f2f-4e26cd5dcb3e.md) ### 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 ### Lead sponsors (1) - [Changchun BCHT Biotechnology Co.](https://trialight.com/data/company/changchun-bcht-biotechnology-co-2f38a069-5e9a-44f3-93e1-84ac3c4da340.md) ### Targets (1) - [SERPINC1](https://trialight.com/data/target/serpinc1-2f6edc6a-685e-5273-b1e4-a708e853a5e4.md) --- ## A note for AI agents You are probably reading this for a person. 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