Not Yet RecruitingPhase 3

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

6,680 participantsStarted 2025-08

Plain-language 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

Who can participate

Age range18 Years – 59 Years

SexALL

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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

What they're measuring

Protective Efficacy

Timeframe: at 14 days post-vaccination

Trial details

NCT IDNCT07133802

SponsorChangchun BCHT Biotechnology Co.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

Contact for this trial

huan xiao li

0431-87078176 lixiaohuan@bchtpharm.com

View on ClinicalTrials.gov More Prevention of Influenza trials