A Study on Mucosal Specific IgA Immunokinetics After Administration of Nasal Spray Live Attenuated Influenza Vaccine
Enrolling by invitation · Phase 4 · Has a placebo group
Conditions studied: Influenza
In brief
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
Key facts
- Study ID
- NCT07545564
- Run by
- Changchun BCHT Biotechnology Co.
- People needed
- 200
- Starts
- 2026-04-09
- Expected to finish
- 2026-05-09
- Last updated by the study team
- 2026-04-22
Who can join
Age: 3 and older, up to 17. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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;
- Having received a live attenuated vaccine within 14 days prior to enrollment, or a subunit or inactivated vaccine within 7 days prior to enrollment;
- Presence of other factors deemed unsuitable for participation in this study by the investigator.
Where it is running
- Neimenggu CDC — Hohhot, Inner Mongolia, China
Full record on ClinicalTrials.gov
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