Influenza
Conditions
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
Interventions
BIOLOGICALLAIV
Nasal spray live attenuated influenza vaccine
BIOLOGICALPlacebo
sterile water
Sponsors
Changchun BCHT Biotechnology Co.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
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; * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Membrane-specific sIgA antibody | 14days after vaccination |
Countries
China
Outcome results
None listed