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 | Not Yet Recruiting Phase 3

• 1 other identifier: B1506-20250113
• Study Type: interventional
• Target: 6,680
• Locations: 0 countries
• Sites: N/A

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

Conditions

Prevention of Influenza

Outcome Measures

Primary Outcomes (1)

• Protective Efficacy

  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

  at 14 days post-vaccination

Secondary Outcomes (7)

• Protective Efficacy

  at 14 days post-vaccination

• Protective Efficacy

  Throughout the entire study period

• Protective Efficacy

  Throughout the entire study period

• Safety

  14 days post-vaccination

• Safety

  30 days post-vaccination

Study Arms (2)

Nasal Spray Live Attenuated Influenza Vaccine

EXPERIMENTAL

Biological: Test Group

Placebo

PLACEBO COMPARATOR

Biological: Placebo Group

Interventions

Placebo Group BIOLOGICAL

Each human dose: 0.2 mL

Placebo

Test Group BIOLOGICAL

Each human dose is 0.2 mL

Nasal Spray Live Attenuated Influenza Vaccine

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants aged 18-59 years
• Capable of providing informed consent in person
• Willing and able to comply with all clinical trial requirements

You may not qualify if:

• 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

Sponsors & Collaborators

• Changchun BCHT Biotechnology Co.: lead
• Hubei Provincial Center for Disease Control and Prevention: collaborator
• Center for Disease Control and Prevention, Fujian: collaborator
• Zhejiang Provincial Center for Disease Control and Prevention: collaborator

Central Study Contacts

huan xiao li

CONTACT

0431-87078176; lixiaohuan@bchtpharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: August 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share