Influenza
Conditions
Interventions
The vaccination group (Self-Controlled):Add the vaccine diluent as indicated on the label. After the vaccine is dissolved and shaken well, it is ready for use. Draw at least 0.2 ml of the reconstitute
Sponsors
Jiangsu Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
14 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Individuals aged 14-17 years. 2. Volunteers and their guardians are able and willing to comply with the requirements of the clinical trial protocol and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Allergy to any component of the vaccine product, including eggs, excipients, or gentamicin sulfate. 2. Individuals with acute illnesses, severe chronic illnesses, acute exacerbations of chronic illnesses, or fever. 3. Pregnant or lactating women. 4. Individuals with Leigh syndrome who are receiving treatment with aspirin or aspirin-containing medications. 5. Individuals with immunodeficiency, immunosuppression, or those undergoing immunosuppressive therapy. 6. Individuals with uncontrolled epilepsy, other progressive neurological disorders, or a history of Guillain-Barré syndrome. 7. Individuals with rhinitis or asthma. 8. Individuals with a personal or family history of seizures, chronic diseases, epilepsy, or allergic tendencies. 9. Asthma patients. 10. Individuals who have received immunoglobulin injections within the last 3 months prior to vaccination. 11. Individuals who have used other live attenuated vaccines within 1 month prior to vaccination. 12. Individuals planning to use antiviral drugs for influenza within 48 hours before or 2 weeks after vaccination. 13. Individuals planning to use any other intranasal medication within 2 days after vaccination. 14. Subjects with underlying gastrointestinal diseases, including but not limited to inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), chronic diarrhea, peptic ulcer, and intestinal polyps. 15. Subjects with metabolic diseases, such as diabetes mellitus, obesity (BMI >= 25.9 kg/m²), hyperlipidemia, or metabolic syndrome. 16. Subjects who have used antibiotics, probiotics, or other drugs that may affect the intestinal microbiota within the past 3 months. 17. Other circumstances in which the subject is deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The level of IgG antibodies (ng/mL) against the vaccine strain in serum at 28 days post-vaccination.;The level of sIgA antibodies (AU/mL) against the vaccine strain in nasal secretions at 28 days post-vaccination.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The levels of cytokines in serum at 7 days post-vaccination.;The levels of cytokines in nasal mucosal secretions at 7 days post-vaccination.;The levels of cytokines in serum at 28 days post-vaccination.;The levels of cytokines in nasal mucosal secretions at 28 days post-vaccination.;The level of IgG antibodies (ng/mL) against the vaccine strain in serum at 7 days post-vaccination.;The level of neutralizing antibodies (NT50 and IC50, ng/mL) against the vaccine strain in serum at 28 days post-vaccination.;The gene expression levels in PBMCs (Peripheral Blood Mononuclear Cells) at 7 days post-vaccination.;The gene expression levels in nasal mucosal cells at 7 days post-vaccination.;The gene expression levels in PBMCs (Peripheral Blood Mononuclear Cells) at 28 days post-vaccination.;The gene expression levels in nasal mucosal cells at 28 days post-vaccination.;The level of sIgA antibodies (AU/mL) against the vaccine strain in nasal secretions at 7 days post-vaccination.; | — |
Countries
China
Contacts
Public ContactJingxin Li
Jiangsu Provincial Center for Diseases Control and Prevention Nanjing, Jiangsu, China
Outcome results
None listed