Enrolling by invitation NCT07545564
A Study on Mucosal Specific IgA Immunokinetics After Administration of Nasal Spray Live Attenuated Influenza Vaccine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LAIV, Placebo.
- Who it may be relevant to
- Registry conditions: Influenza. Basic parameters: 3 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study on Nasal Mucosal Specific IgA Antibody Levels and Immunokinetics After Administration of Nasal Spray Live Attenuated Influenza Vaccine
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
Interventions
- Biological LAIV
Nasal spray live attenuated influenza vaccine - Biological Placebo
sterile water
Primary outcome measures
- Membrane-specific sIgA antibody [Time frame: 14days after vaccination]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Neimenggu CDC — Hohhot
Identifiers
NCT: NCT07545564 · PFLG20260224