Language: BG BG
← Back to results
By invitation only Phase 4 NCT07545564

A Study on Mucosal Specific IgA Immunokinetics After Administration of Nasal Spray Live Attenuated Influenza Vaccine

Phase 4 – monitoring after market approval
Conditions: Influenza

Sponsor: Changchun BCHT Biotechnology Co.

trial.available_in: БГ
Overview
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
Who can participate
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.
Interventions
LAIV
BIOLOGICAL
Placebo
BIOLOGICAL
Locations 1
China (1)
Neimenggu CDC
Hohhot , Inner Mongolia
Technical details
Status
By invitation only
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
3 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
09.04.2026
Completion date
09.05.2026
Registry ID
NCT07545564
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.