NCT07545564
Enrolling By Invitation
Phase 4
A Study on Nasal Mucosal Specific IgA Antibody Levels and Immunokinetics After Administration of Nasal Spray Live Attenuated Influenza Vaccine
Changchun BCHT Biotechnology Co.1 site in 1 country200 target enrollmentStarted: April 9, 2026Last updated:
Overview
- Phase
- Phase 4
- Status
- Enrolling By Invitation
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Membrane-specific sIgA antibody
Overview
Brief Summary
Mucosal-specific sIgA antibody GMT;Evaluate the achievement of 2-fold and 4-fold increases in the geometric mean titer (GMT) of specific nasal mucosal sIgA antibodies after vaccination
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 3 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •People aged 3 to 17 years old who voluntarily receive the live attenuated influenza nasal spray vaccine;
- •The participant themselves can comply with the protocol requirements and complete sample collection;
- •Obtain the consent of the participants' guardians and sign the informed consent form;
Exclusion Criteria
- •Axillary temperature \> 37.0°C on the day of enrollment;
- •Received any influenza vaccine within the past 2 years and plans to receive other influenza vaccines during the trial period;
- •Clinically diagnosed with influenza in a medical institution within the past year (with confirmed etiological diagnosis);
- •Individuals with known hypersensitivity to any ingredient contained in this product, including eggs, excipients, and gentamicin sulfate;
- •Individuals suffering from acute diseases, severe chronic diseases, acute exacerbations of chronic diseases, and fever;
- •Pregnant women;
- •Patients with Leigh syndrome who are being treated with aspirin or aspirin-containing medications;
- •Individuals with immunodeficiency or those undergoing immunosuppressive therapy;
- •Individuals with uncontrolled epilepsy and other progressive neurological diseases, or those with a history of Guillain-Barré syndrome;
- •Nasal abnormalities that, in the judgment of a clinician, may affect vaccination, individuals in the medication period for allergic rhinitis, or those currently receiving nasal spray administration;
Arms & Interventions
Placebo
Placebo Comparator
sterile water
Intervention: Placebo (Biological)
Vaccine
Experimental
LAIV
Intervention: LAIV (Biological)
Outcomes
Primary Outcomes
Membrane-specific sIgA antibody
Time Frame: 14days after vaccination
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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