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

NCT ID: NCT07133802

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 6680 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Nasal Spray Live Attenuated Influenza Vaccine

Group Type: EXPERIMENTAL

Test Group

Intervention Type: BIOLOGICAL

Each human dose is 0.2 mL

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo Group

Intervention Type: BIOLOGICAL

Each human dose: 0.2 mL

Interventions

Placebo Group

Each human dose: 0.2 mL

Intervention Type: BIOLOGICAL

Test Group

Each human dose is 0.2 mL

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hubei Provincial Center for Disease Control and Prevention

OTHER

Sponsor Role: collaborator

Center for Disease Control and Prevention, Fujian

OTHER

Sponsor Role: collaborator

Zhejiang Provincial Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role: collaborator

Changchun BCHT Biotechnology Co.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

huan xiao li

Role: CONTACT

lixiaohuan@bchtpharm.com

0431-87078176

Other Identifiers

B1506-20250113

Identifier Type: -

Identifier Source: org_study_id